[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hiv-1-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hiv-1-infection":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,58,0,25,[9,58,77,105,136,166,191,211,240,267,289,316,337,365,393,419,440,477,501,522,550,575,605,629,656],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":34,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100053374","fuyang-jiedu-granules-plus-antiretroviral-therapy-for-hiv-immune-non-responders-with-spleen-kidney-yang-deficiency-100053374",false,"NCT07698548","Fuyang Jiedu Granules Plus Antiretroviral Therapy for HIV Immune Non-Responders With Spleen-Kidney Yang Deficiency","A Pragmatic Randomized Controlled Trial of Fuyang Jiedu Granules Combined With Antiretroviral Therapy for Immune Reconstitution Failure in People With HIV and Spleen-Kidney Yang Deficiency Syndrome","FYJD-INR-pRCT","Inclusion Criteria:Aged 18 to 60 years, male or female. CD4+ T lymphocyte count \\\u003C350 cells\u002FuL. Meets diagnostic criteria for HIV-1 infection according to the Chinese Guidelines for Diagnosis and Treatment of HIV\u002FAIDS (2024 edition).\n\nMeets diagnostic criteria for incomplete immune reconstitution: ART for more than 4 years; peripheral blood viral load below the lower limit of detection (\\\u003C50 copies\u002FmL) for more than 3 years; persistent CD4+ T-cell count \\\u003C350 cells\u002FuL; and exclusion of other causes of long-term low CD4+ T-cell count.\n\nMeets the Traditional Chinese Medicine diagnostic criteria for spleen-kidney yang deficiency syndrome, supported by the designated four-diagnostic instrument (model SZY-ZM-1) where applicable.\n\nVoluntarily agrees to participate and signs informed consent. -\n\nExclusion Criteria:Uncontrolled acute or chronic physical or mental illness. Poor adherence to ART. WBC \\\u003C2 x 10\\^9\u002FL, neutrophils \\\u003C1.0 x 10\\^9\u002FL, hemoglobin \\\u003C90 g\u002FL, platelets \\\u003C75 x 10\\^9\u002FL, or abnormal hepatic\u002Frenal function. Hepatic abnormality is defined as AST, ALT, or total bilirubin \\>=2 times the upper limit of normal; renal abnormality is defined as creatinine clearance below the normal value.\n\nOther serious comorbid disease, such as tumor, cirrhosis, or cardiovascular\u002Fcerebrovascular disease.\n\nPregnancy, lactation, or recent plan for pregnancy\u002Fchildbearing. Use of immunosuppressants or immunomodulators within 6 months before screening. Any other condition judged by the investigator to make the participant unsuitable for the study.\n\n\\-","ALL","18 Years","60 Years",{"count":22,"type":23},240,"ESTIMATED","INTERVENTIONAL",[26],"NA","This pragmatic randomized controlled trial evaluates whether Fuyang Jiedu Granules combined with antiretroviral therapy (ART) improves immune reconstitution in people with HIV who meet criteria for immune reconstitution failure and spleen-kidney yang deficiency syndrome. Eligible participants are adults aged 18 to 60 years with HIV-1 infection, long-term viral suppression on ART, and persistently low CD4+ T-cell counts. A total of 240 participants will be randomized 1:1 to receive Fuyang Jiedu Granules plus ART or ART alone. Treatment lasts 48 weeks, followed by 48 weeks of follow-up. The primary outcomes are absolute CD4+ T-cell count and immune reconstitution response rate. Secondary outcomes include immune homeostasis markers, T-cell activation and Treg proportion, thymic output and inflammation-related markers, HIV RNA viral load, quality of life, clinical symptom scores, all-cause mortality, and safety.",[29,30,31,32,33],"HIV-1 Infection","Acquired Immunodeficiency Syndrome","Immune Reconstitution Failure","Immunological Non-responder","Spleen-Kidney Yang Deficiency Syndrome",[35,36,37,38,39,40,41,42,43,44],"HIV","AIDS","immune non-responder","incomplete immune reconstitution","ART","CD4+ T cell","Traditional Chinese Medicine","Fuyang Jiedu Granules","pragmatic randomized controlled trial","pRCT","NOT_YET_RECRUITING","2026-07-07",{"date":48,"type":49},"2026-07-13","ACTUAL",{"date":51,"type":23},"2026-08",{"date":53,"type":23},"2029-02",{"name":55,"class":56},"Beijing University of Chinese Medicine","OTHER",1,{"id":59,"slug":60,"hasResults":12,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":66,"targetDuration":4,"studyType":24,"phases":67,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":75,"leadSponsor":76,"locationsCount":57},"100053530","qiling-yiqi-tablets-plus-antiretroviral-therapy-for-hiv-immune-non-responders-with-lung-spleen-qi-deficiency-100053530","NCT07698574","Qiling Yiqi Tablets Plus Antiretroviral Therapy for HIV Immune Non-responders With Lung-Spleen Qi Deficiency","A Pragmatic Randomized Controlled Trial of Qiling Yiqi Tablets Combined With Antiretroviral Therapy for Immune Reconstitution Failure in People With HIV and Lung-Spleen Qi Deficiency Syndrome","QLYQ-INR-pRCT","Inclusion Criteria:Aged 18 to 60 years, male or female. CD4+ T lymphocyte count \\\u003C350 cells\u002FuL. Meets diagnostic criteria for HIV-1 infection according to the Chinese Guidelines for Diagnosis and Treatment of HIV\u002FAIDS (2024 edition).\n\nMeets diagnostic criteria for incomplete immune reconstitution: ART for more than 4 years; peripheral blood viral load below the lower limit of detection (\\\u003C50 copies\u002FmL) for more than 3 years; persistent CD4+ T-cell count \\\u003C350 cells\u002FuL; and exclusion of other causes of long-term low CD4+ T-cell count.\n\nMeets the Traditional Chinese Medicine diagnostic criteria for lung-spleen qi deficiency syndrome, supported by the designated four-diagnostic instrument (model SZY-ZM-1) where applicable.\n\nVoluntarily agrees to participate and signs informed consent. -\n\nExclusion Criteria:Uncontrolled acute or chronic physical or mental illness. Poor adherence to ART. WBC \\\u003C2 x 10\\^9\u002FL, neutrophils \\\u003C1.0 x 10\\^9\u002FL, hemoglobin \\\u003C90 g\u002FL, platelets \\\u003C75 x 10\\^9\u002FL, or abnormal hepatic\u002Frenal function. Hepatic abnormality is defined as AST, ALT, or total bilirubin \\>=2 times the upper limit of normal; renal abnormality is defined as creatinine clearance below the normal value.\n\nOther serious comorbid disease, such as tumor, cirrhosis, or cardiovascular\u002Fcerebrovascular disease.\n\nPregnancy, lactation, or recent plan for pregnancy\u002Fchildbearing. Use of immunosuppressants or immunomodulators within 6 months before screening. Any other condition judged by the investigator to make the participant unsuitable for the study.\n\n\\-",{"count":22,"type":23},[26],"This pragmatic randomized controlled trial evaluates whether Qiling Yiqi Tablets combined with antiretroviral therapy (ART) improves immune reconstitution in people with HIV who meet criteria for immune reconstitution failure and lung-spleen qi deficiency syndrome. Eligible participants are adults aged 18 to 60 years with HIV-1 infection, long-term viral suppression on ART, and persistently low CD4+ T-cell counts. A total of 240 participants will be randomized 1:1 to receive Qiling Yiqi Tablets plus ART or ART alone. Treatment lasts 48 weeks, followed by 48 weeks of follow-up. The primary outcomes are absolute CD4+ T-cell count and immune reconstitution response rate. Secondary outcomes include immune homeostasis markers, T-cell activation and Treg proportion, thymic output and inflammation-related markers, HIV RNA viral load, quality of life, clinical symptom scores, all-cause mortality, and safety.",[29,30,31,32,70],"Lung-Spleen Qi Deficiency Syndrome",[35,36,37,38,39,40,41,72,43,44],"Qiling Yiqi Tablets",{"date":48,"type":49},{"date":51,"type":23},{"date":53,"type":23},{"name":55,"class":56},{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":18,"minAge":19,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":24,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":57},"100640474","phase-1-iap-086-1-a-phase-1-single-ascending-dose-first-time-in-human-study-100640474","NCT07596888","IAP-086-1: A Phase 1 Single Ascending Dose First-Time in Human Study","IAP-086-1: A Phase 1 Single Ascending Dose First-Time in Human Study of the Safety, Tolerability and Pharmacokinetics of IAP086 in Persons With HIV-1 on Antiretroviral Therapy","Inclusion Criteria:\n\n1. Able and willing to provide informed consent. Participants must be willing and able to comply with study procedures\n2. Able and willing to provide adequate locator information\n3. Able and willing to comply with all study requirements through Day 28\n4. Agrees not to enroll on another study of an investigational agent during the study period, defined as any unlicensed investigational drug not yet approved for use in humans\n5. Aged ≥ 18 years and ≤ 70 years of age, at the time of informed consent\n6. HIV infection documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E\u002FCIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and\u002For E\u002FCIA, or by HIV-1 antigen, plasma HIV-1 RNA viral assay.\n\n   NOTE: The term \"licensed\" refers to a US FDA-approved kit, which is required for all Investigational New Drug (IND) studies. World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment.\n7. Plasma HIV-1 RNA viral load must meet the following conditions:\n\n   1. \\\u003C 50 copies\u002FmL at 2 time points within 12 months prior to screening\n   2. \\\u003C 50 copies\u002FmL at screening\n   3. Not \\> 1000 copies\u002FmL at any time within 6 months prior to screening\n8. On continuous ART for at least 24 months prior to screening and must continue ART throughout the study. Permitted ART regimens include:\n\n   1. At least 3 ART drugs, one ART drug must include an integrase inhibitor or non-nucleoside reverse transcriptase inhibitor (NNRTI), efavirenz excluded (see 5.2) or\n   2. At least 2 ART drugs including injectables, in which one drug is an integrase inhibitor that is FDA approved or recommended by Department of Health and Human Services Treatment Guidelines.\n\n   NOTE: Other potent fully suppressive antiretroviral combinations will be considered on a case-by-case basis.\n\n   NOTE: No changes or modifications of ART dosing allowed within 30 days prior to screening.\n9. CD4 cell count \\> 350 cells\u002Fmm3 at screening\n10. Hepatitis C virus (HCV) antibody negative or HCV RNA negative at screening\n11. Hepatitis B surface antigen negative at screening\n12. Clinical laboratory parameters obtained at screening as follows:\n\n    1. Platelet count ≥ 125 × 103\u002FµL\n    2. Absolute neutrophil count ≥ 1.5 × 103\u002FµL\n    3. Absolute Lymphocyte levels ≥ 1000 cells\u002FuL\n    4. Hemoglobin ≥ 12 g\u002FdL (male) and ≥ 11 g\u002FdL (females)\n    5. Prothrombin time or international normalized ratio (INR) ≤ 1.1 × upper limit of normal (ULN)\n    6. Serum total bilirubin ≤ 1.5 × ULN. If total bilirubin is elevated, direct bilirubin ≤ 2 × ULN. If ART includes atazanavir, direct bilirubin must be ≤ 1.0 mg\u002FdL\n    7. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 × ULN\n    8. Alkaline phosphatase (ALP) ≤ 1.5 × ULN\n    9. Serum glucose (fasting or non-fasting) ≤ Grade 1\n    10. Lipase ≤ 1.5 × ULN\n    11. Estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin as determined by the 2021 Chronic Kidney Disease Epidemiology Collaboration equation (CKD-Epi equation) found at: https:\u002F\u002Fwww.mdcalc.com\u002Fcalc\u002F3939\u002Fckd-epi-equations-glomerular-filtration-rate-gfr\n    12. Negative serum pregnancy test for women of childbearing potential (WOCBP) with a sensitivity of at least 25 milli-International Units (mIU)\u002FmL at screening\n13. All participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization, egg donation) starting with screening visit through 30 days after receiving study drug\n14. WOCBP, defined as female at birth, is not pregnant, expecting to become pregnant, or breastfeeding or participant assigned male at birth is not expecting to father children, starting with screening visit through 30 days after receiving study product\n15. WOCBP, not surgically sterilized (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy), and not post-menopausal for at least 24 consecutive months, i.e., have had menses within the preceding 24 months, must have a negative serum pregnancy test performed within 72 hours prior to initiation of study drug\n16. WOCBP and male participants of reproductive potential with WOCBP partners must agree to consistently use a highly effective method of contraception and a barrier method (condom, diaphragm or cervical cap) for the duration and for 30 days afterwards. Highly effective methods include the following:\n\n    Highly effective methods include:\n    * Contraceptive subdermal implant\n    * Intrauterine device or intrauterine system\n    * Combined estrogen and progestogen oral contraceptive\n    * Injectable progestogen\n    * Contraceptive vaginal ring\n    * Percutaneous contraceptive patches\n    * True sexual abstinence (only if it is the participant's consistent lifestyle choice and not just trial-related).\n    * Sterilization of male partner with documentation of azoospermia prior to the participant's entry into the study, and this individual is the sole partner for the participant. The documentation of partner sterility can come from the site personnel's review of medical records, medical examination and\u002For semen analysis, or medical history interview provided by the participant or the partner. Self-reported documentation of reproductive potential should be entered in the source documents.\n\n    Barrier method may include:\n    * Male or female condoms with or without a cream or gel that kills sperm\n    * Diaphragm or cervical cap with a cream or gel that kills sperm\n    * Sponge\n17. Participants not of reproductive potential are eligible without requiring the use of contraceptives. Acceptable documentation are specified below.\n\n    NOTE: Men who have sex with men only will not be required to use contraception NOTE: Women who have sex with women only will not be required to use contraception\n\n    NOTE: Written\u002Foral documentation communicated by clinician\u002Fclinician's staff of one of the following:\n    1. Physician report\u002Fletter\n    2. Operative report or other source documentation in the patient record (a laboratory report of azoospermia is required to document successful vasectomy)\n    3. Discharge summary\n    4. Follicle stimulating hormone-release factor (FSH) measurement elevated into the menopausal range as established by the reporting laboratory\n18. Willingness to defer vaccinations, including influenza and Coronavirus Disease (COVID-19) vaccines, from 30 days prior to Day -1 through Day 28 post-infusion\n19. Willingness to abstain from alcohol, illicit drugs and grapefruit juice and limit caffeine intake from 24 hours prior to study treatment through Day 7\n20. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests\n21. Body mass index of less than 35\n\nExclusion Criteria:\n\n1. Current use of moderate or strong CYP3A inhibitors or inducers for any indication including current use of a protease inhibitor, ritonavir, cobicistat, or efavirenz as part of ART regimen (See Section 6.1.1)\n2. Significant history or presence of respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological disorders, immunodeficiency other than HIV-1, or clinical condition capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data\n3. Unstable asthma (e.g. sudden acute attacks occurring without an obvious trigger) or asthma requiring:\n\n   1. Daily steroid or long-acting beta-agonist prevention\n   2. Hospitalization in the last two years\n4. Clinically significant cardiovascular disease within 12 months prior to screening including but not limited to:\n\n   1. Myocardial infarction or unstable angina\n   2. Cardiac arrhythmias\n   3. Uncontrolled hypertension at screening: systolic blood pressure \\> 180 mmHg, diastolic blood pressure \\>100 mmHg that is sustained on repeat measurement (without intervention)\n   4. Cerebrovascular accident\n   5. Congestive heart failure, New York Heart Association class II-IV\n5. QTc \\>450 msec at screening NOTE: QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), and\u002For another method, machine-read or manually over-read\n6. Diabetes mellitus ≥ Grade 3 per DAIDS criteria (defined as uncontrolled despite treatment modification or hospitalization for immediate glucose control indicated)\n7. History of malignancy within the last 3 years NOTE: History of non-melanoma skin cancer (e.g., basal cell carcinoma or squamous cell skin cancer) is not exclusionary with documentation of resolution per topical treatment or complete resection as determined by a dermatologist at least 3 months prior to screening\n8. Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral antibiotic, antiviral, or antifungal treatment within 14 days prior to the initiation of study drug.\n9. History of coagulopathy or other bleeding disorder or current or anticipated need for chronic anti-coagulation\n10. An underlying skin disease or disorder including, but not limited to, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria, or tattoo that would interfere with assessment of infusion sites\n11. History of severe allergic reaction with generalized urticarial, angioedema, or anaphylaxis\n12. Use of any prescription or non-prescription drugs or dietary supplements that are prohibited (See Section 6.11), within 7 days prior to dosing\n13. Use of any immunosuppressive, immunomodulatory or cytokine therapy within 90 days prior to entry. Not Exclusionary: \\[1\\] corticosteroid nasal spray; \\[2\\] inhaled corticosteroids; \\[3\\] topical steroids for mild, uncomplicated dermatitis unless it interferes with assessment of infusion site reactions; or \\[4\\] a single course of oral \u002Fparenteral prednisone or equivalent at doses \\\u003C20mg\u002Fday and length of therapy \\\u003C14 days with completion at least 30 days prior to enrollment.\n14. Use of any other investigational treatment within 6 months prior to enrollment, with the exception of Phase II or higher studies of antiretroviral agents\n15. Regular use (daily to weekly) of known drugs of abuse within 3 months of enrollment\n16. Increased alcohol consumption within 6 months prior to screening, defined as an average weekly intake of \\>14 units for males or \\>7 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\\~240mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.\n17. Current tobacco use or current use of nicotine-containing products (e.g. nicotine patches or vaporizing devices) within 6 months prior to screening\n18. Known sensitivity to any of the study interventions, or components thereof, or study drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study\n19. Any other clinical condition, behavior or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits",true,"70 Years",{"count":87,"type":23},30,[89],"PHASE1","Purpose: To assess the safety and tolerability of a single dose of IAP086 in persons with HIV suppressed on stable ART Participants: 30 people from UNC within 18 to 70years of age. People with HIV on ART with plasma HIV-1 RNA \\\u003C 50 copies\u002FmL for 12 months prior to screening.\n\nProcedures (methods):\n\nThe participant's standard of care ART regimen is continued throughout the study period.\n\nThis study requires an overnight stay in a research unit. During the overnight stay, participants will receive a single infusion (medicine given slowly through a vein in their arm) of IAP086 and be monitored for 24 hours. Each later participant receives IAP086 at the same or a higher dose decided in advance. The dose will increase as more participants receive IAP086 without concerning side effects. Study visits also occur 2, 3, 7, 14, 21 and 28 days after the study drug is given. Study procedures include review of the medical history, physical exams, and blood draws.",[92],"HIV-1-infection",[94],"HIV-1 on Antiretroviral Therapy","RECRUITING","2026-06-22",{"date":98,"type":49},"2026-06-24",{"date":100,"type":49},"2026-06-18",{"date":102,"type":23},"2027-05",{"name":104,"class":56},"University of North Carolina, Chapel Hill",{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":84,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":24,"phases":114,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":4},"100641318","intestinal-tissue-resident-memory-t-cells-and-hiv-1-persistence-during-antiretroviral-therapy-100641318","NCT07656077","Intestinal Tissue-Resident Memory T Cells and HIV-1 Persistence During Antiretroviral Therapy","Intestinal Tissue-Resident Memory T Cells in HIV-1 Infection: Mechanisms Involved in Their Depletion and Role in Viral Persistence During Antiretroviral Therapy","ANRSGALT-2","I - Inclusion criteria\n\n1 - Group 1: People Living With HIV-1\n\n* Age ≥ 18 years\n* Documented HIV-1 infection\n* Continuous suppressive antiretroviral therapy initiated during chronic infection for at least 12 months\n* Plasma HIV-1 RNA ≤ 50 copies\u002FmL for at least 6 months under ART (one isolated blip ≤ 200 copies\u002FmL allowed)\n* Blood CD4+ T-cell count ≥ 350 cells\u002Fmm³\n* Clinically indicated colonoscopy independent of the research protocol\n* Affiliation with a social security system\n* Written informed consent obtained before any study-specific procedure\n\n  2- Group 2: HIV-Seronegative Controls\n* Age ≥ 18 years\n* HIV-seronegative status\n* Clinically indicated colonoscopy independent of the research protocol\n* Affiliation with a social security system\n* Written informed consent obtained before any study-specific procedure\n\nII - Exclusion Criteria\n\n1. Group 1: People Living With HIV-1\n\n   * HIV-2 infection\n   * Inflammatory bowel disease (Crohn's disease or ulcerative colitis) or celiac disease\n   * Platelet count \\\u003C 50 G\u002FL or uncorrectable coagulation disorders contraindicating biopsies\n   * Decompensated cirrhosis\n   * History of lymphoma\n   * Participation in an HIV vaccine or immunotherapy study\n   * Pregnant or breastfeeding women\n   * Participation in another clinical study with an ongoing exclusion period\n   * Vulnerable individuals, including minors, individuals under guardianship, or persons deprived of liberty\n2. Group 2: HIV-Seronegative Controls\n\n   * HIV-1 or HIV-2 infection\n   * Refusal to undergo HIV serology testing\n   * Inflammatory bowel disease (Crohn's disease or ulcerative colitis) or celiac disease\n   * Platelet count \\\u003C 50 G\u002FL or uncorrectable coagulation disorders contraindicating biopsies\n   * Decompensated cirrhosis\n   * History of lymphoma\n   * Pregnant or breastfeeding women\n   * Participation in another clinical study with an ongoing exclusion period\n   * Vulnerable individuals, including minors, individuals under guardianship, or persons deprived of liberty",{"count":87,"type":23},[26],"The study aims to better characterize intestinal tissue-resident memory T cells (TRM) in people living with HIV-1 receiving suppressive antiretroviral therapy (ART). TRM cells are key components of tissue immunity and may contribute to HIV-1 persistence within the intestinal mucosa, a major viral reservoir. The phenotypic, transcriptomic, and functional characteristics of intestinal CD4+ and CD8+ TRM cells, their susceptibility to HIV-1 infection, and their potential role as viral reservoirs will be investigated. Blood samples and additional colonic biopsies obtained during routine clinically indicated colonoscopy will be collected from HIV-1-infected participants and HIV-seronegative controls.",[29,117,118],"HIV Reservoir","Antiretroviral Therapy",[120,121,122,39,123,124,125,126],"HIV-1","Tissue-Resident Memory T Cells","Viral Reservoir","Intestinal Mucosa","Mucosal Immunity","CD4 T Cells","HIV Persistence","2026-06-14",{"date":100,"type":49},{"date":130,"type":23},"2026-08-01",{"date":132,"type":23},"2030-07-31",{"name":134,"class":135},"ANRS, Emerging Infectious Diseases","OTHER_GOV",{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":85,"enrollmentInfo":143,"targetDuration":4,"studyType":24,"phases":145,"briefSummary":146,"conditions":147,"keywords":148,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":165},"100591968","phase-1-a-study-to-evaluate-the-safety-and-antiviral-activity-of-two-human-monoclonal-antibodies-vrc07-523ls-and-pgt121414ls-during-analytic-treatment-interruption-in-participants-living-with-hiv-who-initiated-art-during-acuteearly-hiv-1-infection-100591968","NCT06987318","A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) During Analytic Treatment Interruption in Participants Living With HIV Who Initiated ART During Acute\u002FEarly HIV-1 Infection","A Phase I Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) During Analytic Treatment Interruption in Participants Living With HIV Who Initiated ART During Acute\u002FEarly HIV-1 Infection","Inclusion Criteria:\n\n* Ability and willingness of participant to provide informed consent.\n* Initiation of combination ART within 90 days of acute HIV diagnosis as defined by any of the criteria listed below:\n\n  * A negative HIV Ab or HIV Ag\u002FAb Combination Assay and a detectable HIV-1 RNA (qualitative or quantitative) or a subsequently positive Western blot (WB) or equivalent HIV-1 confirmatory assay (e.g. Geenius assay) if no positive HIV-1 RNA test was available.\n  * A positive HIV Ab or HIV Ag\u002FAb Combination Assay or p24 antigen test and a negative or indeterminate HIV confirmatory\u002Fdifferentiating test with a detectable HIV-1 RNA (qualitative or quantitative).\n  * A positive HIV Ab or HIV-1 RNA or p24 antigen and positive WB or Geenius HIV-1\u002FHIV-2 Supplemental Assay that is negative for p31 band.\n  * Two different rapid HIV tests with discordant results followed by subsequently positive HIV serum antibody and\u002For HIV-1 RNA tests.\n  * A positive HIV antibody test according to standard criteria obtained within 60 days after an initial negative or indeterminate HIV antibody, antigen, or nucleic acid amplification.\n* For women who are able to become pregnant, negative serum or urine pregnancy test within 48 hours prior to Step 1 entry.\n* All study candidates must agree not to participate in an assisted conception process (e.g., sperm donation, intrauterine insemination, in vitro fertilization) from the screening visit until 12 weeks after the final study visit.\n* Women who can become pregnant and are engaging in sexual activity that could lead to pregnancy must agree to use one highly effective method of contraception from Step 1 entry until 12 weeks after the final study visit.\n* Willingness to use barrier protection (male or female) during sexual activity during ATI and through confirmed viral resuppression.\n* Weight ≥50 kg and ≤150 kg at screening.\n* On stable suppressive ART for at least 12 months prior to Step 1 entry. No known ART interruption for longer than 14 days within 12 months prior to Step 1 entry. No more than two known ART interruptions of a duration between 14 and 60 consecutive days since initiation of ART.\n* ART regimens must contain a protease inhibitor (PI) or integrase strand transfer inhibitor (INSTI) as one of the active drugs in the ART regimen at the time of Step 1 entry.\n* CD4+ cell count of \\>450 cells\u002FmL obtained within 60 days prior to Step 1 entry.\n* Within 60 days prior to Step 1 entry, plasma HIV-1 RNA \\\u003C 50 copies\u002FmL of plasma.\n* Plasma HIV-1 RNA \\\u003C50 copies\u002FmL (or below the assay limit of quantification if the local assay limit of quantification is \\>50 copies\u002FmL) since initial viral suppression on ART and for at least 1 year prior to Step 1 entry.\n* Willingness to participate in an ATI.\n* The following laboratory values obtained within 60 days prior to Step 1 entry:\n\n  * Absolute neutrophil count (ANC) ≥1000 cells\u002Fmm\\^3\n  * Hemoglobin ≥12.0 g\u002FdL for men and ≥11.0 g\u002FdL for women\n  * Platelet count ≥125,000\u002Fmm\\^3\n  * Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73 m\\^2 calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) 2021 equation\n  * Total bilirubin \\\u003C1.5 x upper limit of normal (ULN)\n  * Aspartate aminotransferase (AST) (SGOT) \\\u003C1.5 x ULN\n  * Alanine aminotransferase (ALT) (SGPT) \\\u003C1.5 x ULN\n  * Alkaline phosphatase \\\u003C1.5 x ULN\n* Hepatitis C virus (HCV) antibody negative result within 60 days prior to Step 1 entry or, for participants who are HCV antibody positive (based on testing performed at any time prior to Step 1 entry), a negative HCV RNA result obtained within 60 days prior to Step 1 entry.\n* Negative hepatitis B surface antigen (HBsAg) result obtained within 60 days prior to Step 1 entry.\n* Ability and willingness to restart ART following ATI according to study guidelines.\n* Completion of pre-entry leukapheresis or Large Volume Blood Draw (LVBD).\n\nExclusion Criteria:\n\n* Breastfeeding or plans to become pregnant within the next 36 months.\n* Known allergy\u002Fsensitivity or any hypersensitivity to components of study treatment or its formulation.\n* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n* Receipt of any investigational vaccine within 6 months prior to Step 1 entry.\n* Receipt of any vaccine within 14 days prior to Step 1 entry.\n* Prior receipt of anti-HIV broadly neutralizing antibody therapy.\n* Prior receipt of a latency-reversing agent (LRA), whether licensed or investigational, unless reviewed and approved by the study's CMC.\n* AIDS-defining illness or opportunistic infection within 24 months prior to Step 1 entry.\n* Any clinically significant acute or chronic medical condition (such as autoimmune diseases), other than HIV infection, that in the opinion of the investigator would preclude participation.\n* Any history of an HIV-associated malignancy, including Kaposi's sarcoma and any type of lymphoma, or virus-associated cancers.\n* History of progressive multifocal leukoencephalopathy (PML).\n* Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery within 36 months prior to Step 1 entry or for whom such therapies are expected in the subsequent 12 months.\n* Receipt of cabotegravir-LA intramuscular (IM) or rilpivirine-LA IM or lenacapavir (SQ) within 24 months prior to Step 1 entry.\n* Resistance to one or more drugs in two or more ARV drug classes.\n* History of systemic corticosteroids (long-term use), immunosuppressive anti-cancer or other immunosuppressive agents, interleukins, systemic interferons, systemic chemotherapy, or other medications considered significant by the investigator within the 6 months prior to Step 1 entry.\n* History of or current clinical atherosclerotic cardiovascular disease (ASCVD), as defined by 2013 ACC\u002FAHA guidelines, including a previous diagnosis of any of the following:\n\n  * Acute myocardial infarction\n  * Acute coronary syndromes\n  * Stable or unstable angina\n  * Coronary or other arterial revascularization\n  * Stroke\n  * Transient ischemic attack\n  * Peripheral arterial disease presumed to be of atherosclerotic origin\n* For participants aged ≥40: 10-year ASCVD risk score estimated by Pooled Cohort Equations \\>20% within 60 days prior to Step 1 entry.\n* Acute or serious illness requiring systemic treatment and\u002For hospitalization within 60 days prior to Step 1 entry.",{"count":144,"type":23},40,[89],"The purpose of this study is to evaluate the safety, tolerability, and efficacy of combination broadly neutralizing antibodies (bNAbs), to induce HIV-1 control during analytic treatment interruption (ATI).",[92],[149,150,151,152,35,153,154],"Suppressive Antiretroviral Therapy","Acute HIV-1","Broadly neutralizing antibody","Antibodies","HIV antibody","HIV Broadly neutralizing antibody","2026-06-12",{"date":157,"type":49},"2026-06-15",{"date":159,"type":23},"2026-12-01",{"date":161,"type":23},"2028-05-07",{"name":163,"class":164},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",13,{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":12,"sex":18,"minAge":173,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":24,"phases":176,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":190},"100541989","phase-4-a-study-to-provide-continued-access-to-study-drug-to-children-and-adolescents-who-have-completed-clinical-studies-involving-gilead-hiv-treatments-100541989","NCT06337032","A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments","An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments","Key Inclusion Criteria:\n\n* Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, or GS-US-216-0128, and gave consent to study participation.\n\nKey Exclusion Criteria:\n\n* Individuals planning to switch to B\u002FF\u002FTAF on Day 1 with plasma HIV RNA ≥ 50 copies\u002FmL during the last parent study visit prior to screening\u002FDay 1 visit.\n\n  * Note: individuals planning to switch after Day 1 must not have plasma HIV RNA ≥ 50 copies\u002FmL (or detectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies\u002FmL).\n* Individuals planning to switch to B\u002FF\u002FTAF with any ongoing Grade 3 or 4 drug-related AE or clinically relevant Grade 3 or 4 drug-related laboratory abnormality (confirmed on repeat) related to any component of B\u002FF\u002FTAF prior to treatment switch.\n* For those on B\u002FF\u002FTAF or planning to switch to B\u002FF\u002FTAF: previous treatment discontinuation of any component of B\u002FF\u002FTAF due to toxicity or intolerance.\n* For those planning to switch to B\u002FF\u002FTAF: known hypersensitivity to any component of the study drug, its metabolites, or formulation excipients.\n* Ongoing treatment with or prior use of any prohibited medications.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","1 Month",{"count":175,"type":23},350,[177],"PHASE4","The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events.\n\nThe primary objectives of this study are as follows:\n\n* To provide continued access to the study drug received in the parent protocol or switch to bictegravir\u002Femtricitabine\u002Ftenofovir (B\u002FF\u002FTAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment.\n* To evaluate the safety of the study drug(s) in participants with HIV-1.",[92],"2026-06-09",{"date":182,"type":49},"2026-06-10",{"date":184,"type":49},"2024-08-27",{"date":186,"type":23},"2034-03",{"name":188,"class":189},"Gilead Sciences","INDUSTRY",15,{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":24,"phases":200,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":4},"100642421","phase-2-a-study-of-gs-3242-in-combination-with-lenacapavir-versus-biktarvy-in-virologically-suppressed-people-with-hiv-1-100642421","NCT07645287","A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1","A Phase 2 Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir\u002FEmtricitabine\u002FTenofovir Alafenamide) in Virologically Suppressed People With HIV-1","Key Inclusion Criteria:\n\n* Documented human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \\\u003C 50 copies\u002FmL for ≥ 6 months before screening.\n* Plasma HIV-1 RNA levels \\\u003C 50 copies\u002FmL at screening.\n* Receiving bictegravir\u002Femtricitabine\u002Ftenofovir alafenamide (coformulated; Biktarvy®) (B\u002FF\u002FTAF) for ≥ 6 months prior to screening.\n* No documented resistance to GS-3242 (integrase mutation Q148H\u002FK\u002FR plus at least 2 of the following integrase mutations: L74I\u002FM, T97A, E138A\u002FK\u002FT, or G140A\u002FC\u002FS).\n\nKey Exclusion Criteria:\n\n* Prior use of, or exposure to GS-3242 or LEN.\n* History of virologic failure while on an integrase strand transfer inhibitor (INSTI)-based regimen.\n* Prior use of any long-acting parenteral antiretroviral therapy (ART) medications such as monoclonal antibodies or broadly neutralizing antibodies targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":199,"type":23},175,[201],"PHASE2","The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir\u002Femtricitabine\u002Ftenofovir alafenamide (B\u002FF\u002FTAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35. In Part B the goal of the study is to compare the effectiveness of switching to the study drugs, GS-3242 and LEN versus continuing B\u002FF\u002FTAF in Groups 4 and 3 at Week 26.\n\nThe primary objective of part A is to evaluate the efficacy of switching to intramuscular (IM) GS-3242 plus IM LEN versus continuing on B\u002FF\u002FTAF PWH who are virologically suppressed in treatment Groups 1, 2, and 3 at Week 35 and Part B is to evaluate the efficacy of switching to IM GS-3242 plus IM LEN versus continuing on B\u002FF\u002FTAF in PWH who are virologically suppressed in Treatment Groups 4 and 3 at Week 26.",[92],"2026-06-08",{"date":155,"type":49},{"date":207,"type":23},"2026-06",{"date":209,"type":23},"2033-04",{"name":188,"class":189},{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":24,"phases":220,"briefSummary":221,"conditions":222,"keywords":223,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":239},"100521605","phase-1-evaluation-of-safety-immunogenicity-and-efficacy-of-a-triple-immune-regimen-in-adults-initiated-on-art-during-acute-hiv-1-100521605","NCT06071767","Evaluation of Safety, Immunogenicity and Efficacy of a Triple Immune Regimen in Adults Initiated on ART During Acute HIV-1","A Phase I\u002FIIa Randomized, Placebo-Controlled Trial of Conserved-Mosaic T-cell Vaccine in a Regimen With Vesatolimod and Broadly Neutralizing Antibodies in Adults Initiated on Suppressive Antiretroviral Therapy During Acute HIV-1","Inclusion Criteria\n\n* Provision of written informed consent.\n* History of Initiation of combination ART within 90 days of acute HIV diagnosis\n* On ART for at least 12 months with no known ART interruption \\>28 consecutive days within 12 months prior to Step 1 Study Entry\n* ART with an integrase inhibitor-based regimen with two NRTIs or dolutegravir\u002Flamivudine regimen for at least 6 weeks prior to Study Entry.\n* Willingness to participate in the ATI and willingness to restart ART according to study guidelines.\n* Willingness to adhere to protocol therapy and complete all study visits.\n* Weight ≥50 kg and ≤150 kg at Screening.\n* CD4 cell count ≥450 cells\u002Fmm3 obtained within 60 days prior to Study Entry.\n* HIV-1 RNA \\\u003C50 copies\u002FmL (or below the assay limit of quantification if local assay lower limit of quantification is \\>50 copies\u002FmL) for at least 1 year and within 60 days prior to Study Entry.\n* Select laboratory results within 60 days of study entry\n* For cisgender women and transgender men of reproductive potential, negative urine or serum pregnancy test within 48 hours prior to or at study Entry.\n* Participants who are able to become pregnant and who are engaging in sexual activity that could lead to pregnancy must agree to use two methods of contraception, one of which must be a highly effective methods for contraception. Barrier methods of contraception are required for the second method of contraception.\n* Availability of results of HLA typing (required for randomization).\n* Completion of pre-entry leukapheresis or LVBD.\n\nExclusion Criteria\n\n* Currently pregnant or breastfeeding or planning to become pregnant during study participation.\n* Prior receipt of anti-HIV broadly neutralizing antibody therapy.\n* Receipt of any non-HIV monoclonal antibody therapy within 1 year prior to study entry.\n* Prior receipt of a latency-reversing agent (LRA).\n* Receipt of HIV-1 or other investigational vaccines within 6 months prior to Study Entry.\n* Receipt of a live-virus vaccine within 60 days or any vaccination within 14 days prior to Study Entry.\n* Receipt of any simian adenovirus-vectored vaccine (e.g., anti-COVID-19 AZD1222) within 12 months prior to Step 1 Study Entry.\n* Known allergy\u002Fsensitivity or any hypersensitivity to components of study treatments or their formulations.\n* Known severe chicken egg allergy.\n* Known history of a severe reaction or anaphylaxis to prior vaccinations or antibody preparations (e.g., intravenous immunoglobulin).\n* Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity).\n* Any history of anaphylaxis and related symptoms such as hives, respiratory difficulty, or angioedema.\n* Previous or current history of bleeding factor deficiency, coagulopathy or platelet disorder or on chronic anticoagulation.\n* History of inflammatory neurologic diseases.\n* History of pregnancy, head trauma or major surgery within 90 days prior to Step 1 Study Entry.\n* History of use of any immunomodulatory medications within the 6 months prior to Step 1 Study Entry.\n* Significant serious skin disease, such as but not limited to active rash, eczema, psoriasis, or urticaria.\n* Autoimmune disease (e.g., lupus, multiple sclerosis, and others) requiring ongoing immunosuppression.\n* Known history of CDC Stage 3 opportunistic infection (OI).\n* Any history of an HIV-associated malignancy.\n* Known or suspected active or untreated latent Mycobacterium tuberculosis infection.\n* Active or recent non-HIV-associated malignancy.\n* Serious illness requiring systemic treatment and\u002For hospitalization within 90 days prior to study entry.\n* Known resistance to one or more drugs in two or more ARV drug classes.\n* History of or current clinical atherosclerotic cardiovascular disease\n* Current advanced liver disease.\n* Use of complementary or alternative medicines within 14 days prior study entry.",{"count":219,"type":23},36,[89,201],"The purpose of this study is to evaluate the safety, tolerability, and efficacy of therapeutic vaccination with chimpanzee adenovirus ChAdOx1- and poxvirus modified vaccinia Ankara (MVA)-vectored conserved mosaic T-cell vaccines in a sequential regimen with the toll-like receptor 7 (TLR7) agonist vesatolimod (VES) and two broadly neutralizing antibodies (bNAbs) compared to placebo, to induce HIV-1 control during analytic treatment interruption (ATI).",[92],[149,35,150,224,225,226,227,228,229,230,231,232,151,152,153,154],"HIV vaccine","T-cell vaccine","Therapeutic T-cell vaccine","ChAdOx1","MVA","Conserved region vaccine","HIVconsvX","Toll-like receptor 7 agonist","TLR7",{"date":182,"type":49},{"date":235,"type":49},"2024-04-01",{"date":237,"type":23},"2029-08-01",{"name":163,"class":164},12,{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":248,"minAge":249,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":24,"phases":252,"briefSummary":253,"conditions":254,"keywords":255,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":262,"leadSponsor":264,"locationsCount":266},"100638694","phase-4-dolutegravirlamivudine-in-treatment-nave-pregnant-women-100638694","NCT07616739","Dolutegravir\u002FLamivudine in Treatment-Naïve Pregnant Women","Evaluating the Efficacy and Safety of Dolutegravir\u002FLamivudine (DTG\u002F3TC) in ART-Naïve Pregnant Women","PREDUAL","Inclusion Criteria:\n\nAll persons who are eligible must meet all of the following:\n\n1. Confirmed HIV-1 infection: All tests must use blood, serum, or plasma samples. Documentation may be obtained from medical records. HIV-1 positive is defined as having HIV-1 RNA in plasma ≥ 1000 copies\u002FmL, plus one antibody test or two positive HIV antibody tests (two different rapid tests or one rapid test and one positive ELISA\u002FEIE test). If any of these diagnostic test results are not available, they will be performed at the SCR visit. In all cases, an HIV viral load test will be performed.\n2. Not exposed to prior antiretroviral therapy (ART): No prior antiretroviral therapy, including exposure to PrEP and\u002For PEP in the last 6 months.\n3. Ability to sign the informed consent form.\n4. Plasma HIV-1 RNA ≥1000 copies\u002FmL. Viral load from the last 30 days may be valid. . Age ≥ 16 years or older in Argentina, ≥ 15 years or older in Brazil. The participant must be of the age required in their country of residence to give legal informed consent. Otherwise, informed consent must be signed by a parent or legal guardian, according to country guidelines, in addition to the participant.\n\n6\\. Pregnant at any gestational age up to 32 weeks at the time of the screening visit: Viable pregnancy with a gestational age ≤32 weeks, defined according to menstrual history and\u002For ultrasound. Note: If the menstrual history is unknown or if there is a discrepancy between the menstrual history and the ultrasound, the gestational age will be determined based on the best technology available at each center.\n\n7\\. The participant intends to continue with the pregnancy.\n\nExclusion Criteria:\n\nAll eligible individuals must NOT meet any of the following criteria:\n\n1. Documented resistance to 3TC (presence of the M184V\u002FI mutation) or DTG (defined as the presence of G118R, Q148 H\u002FK\u002FR, or R263K).\n2. Active hepatitis C infection. 3. Active hepatitis B (HBsAg positive or detectable HBV viral load in cases with isolated positive HBV anti-core).\n3. Hemoglobin \\\u003C8 g\u002FdL.\n4. Fetal abnormalities detected on ultrasound\n5. Concomitant medications required with possible drug interactions specified in section 5.10.\n6. ALT \\>=5 times the ULN, or ALT \\>=3xULN and bilirubin \\>=1.5xULN (with \\>35% direct bilirubin). Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification\n7. Presence of severe preeclampsia or other pregnancy-related events, in current or previous pregnancies, such as renal or hepatic abnormalities (grade 2 or higher proteinuria, elevated serum creatinine, CrCl \\\u003C50 mL\u002Fmin, total bilirubin, ALT, or AST).\n8. Active opportunistic infection at screening: active severe opportunistic infections and\u002For severe bacterial infection, including active tuberculosis or severe disease or unstable clinical condition within 14 days prior to study entry.\n9. Any patient or disease-related condition that, in the investigator's opinion, would prevent the patient from adhering to study medication or complying with study visits or procedures.\n10. Problematic drug and\u002For alcohol use, which in the opinion of the site investigator could interfere with therapeutic compliance with study requirements.\n11. Known allergy or sensitivity to any of the study medications or their formulations.\n12. Vomiting or any other reason generating inability to swallow medications due to a pre-existing active disorder that prevents proper swallowing and absorption of study medications.\n13. Creatinine Clearance of \\\u003C30 mL\u002Fmin . If a creatinine value was obtained within 30 days prior to the screening visit, it may be used to calculate the CrCl.","FEMALE","15 Years",{"count":251,"type":23},210,[177],"Protocol Number: FH-94\n\nStudy Objetives:\n\nPrimary:\n\n* To evaluate the virological response to Dolutegravir\u002FLamivudine in naive pregnant women with HIV who are starting antiretroviral therapy and vertical transmission in exposed neonates.\n\nSecondary:\n\n* To evaluate the incidence of maternal adverse events.\n* To evaluate perinatal outcomes at delivery.\n* To evaluate maximum virological suppression at delivery.\n* To evaluate the incidence of changes in body weight exceeding what is expected for gestation.\n* To evaluate the immune response based on changes in CD4, CD8, and CD4\u002FCD8 ratio values during pregnancy.\n* Assess baseline resistance and the development of resistance to virological failure to integrase inhibitors and INTRs during treatment with DTG+3TC or DTG+TDF\u002FXTC or DTG+TAF\u002FFTC.\n* To evaluate the incidence of HIV infection in children that breastfeed.\n* To evaluate safety outcomes and virological response of DTG+3TC compared to DTG+TDF\u002FXTC or DTG+TAF\u002FFTC.\n\nExploratory:\n\n* To explore the non-inferiority of DTG+3TC therapy compared to DTG+TDF\u002FXTC or DTG+TAF\u002FFTC treatment.\n* To evaluate the frequency of antiretroviral therapy withdrawal or modification before delivery.",[92],[256,257],"antiretroviral naive triple therapy","Dolutegravir-Lamivudine dual-therapy","2026-05-27",{"date":260,"type":49},"2026-06-01",{"date":157,"type":23},{"date":263,"type":23},"2028-09-15",{"name":265,"class":56},"Fundación Huésped",10,{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":18,"minAge":274,"maxAge":275,"enrollmentInfo":276,"targetDuration":4,"studyType":24,"phases":278,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":239},"100490042","phase-1-study-of-oral-and-long-acting-injectable-cabotegravir-and-rilpivirine-in-virologically-suppressed-children-living-with-hiv-1-two-to-less-than-12-years-of-age-100490042","NCT05660980","Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age","Phase I\u002FII Study of the Safety, Tolerability, Acceptability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age","Inclusion Criteria, Step 1: Entry for Cohort 1, Cohort 2a, and Cohort 2b\n\n* Parent or legal guardian is willing and able to provide written permission for child's study participation and, when applicable per institutional review board\u002Fethics committee (IRB\u002FEC) policies and procedures, child is willing and able to provide written assent for study participation.\n\nNote: All sites must follow all applicable IRB\u002FEC policies and procedures; for US sites, this includes single IRB (sIRB) policies and procedures.\n\n* Age two years old to less than 12 years old at entry\n* Body weight ≥10 kg and \\\u003C40 kg at entry\n* At entry, willing and able to comply with the study visit schedule and other study requirements, as determined by the site investigator or designee.\n* Confirmed HIV-1-infection based on documented testing of two samples collected from two separate blood collection tubes per Sample #1 and Sample #2 requirements. Test results may be obtained from medical records or from testing performed during the study screening period\n* Has been on a stable unchanged ART regimen consisting of two or more drugs from two or more antiretroviral drug classes for at least six consecutive months (defined as 180 consecutive days) prior to entry.\n* Has no prior history of switching ART regimens for reasons related to treatment failure based on parent\u002Fguardian report and\u002For available medical records.\n\nNote: Participants undergoing dose modifications for growth or who have switched to a new formulation due to toxicity, tolerability, or changes in national treatment guidelines are considered eligible per this inclusion criterion. Treatment failure should be defined by local guidelines.\n\n* From a specimen collected less than six months (defined as within 179 days) prior to entry, has at least one of the following documented plasma HIV-1 RNA results:\n\n  * \\\u003C50 copies\u002FmL, or\n  * less than the lower limit of detection of the assay\n* From a specimen collected in the 6-18 months (defined as 180 to 545 days) prior to entry, has at least one of the following documented plasma HIV-1 RNA results:\n\n  * \\\u003C50 copies\u002FmL, or\n  * less than the lower limit of detection of the assay\n* At screening, a documented plasma HIV-1 RNA \\\u003C50 copies\u002FmL.\n\nNote: HIV-1 RNA test results at screening cannot be used to satisfy previously listed inclusion criterion. If participant does not have a documented HIV-1 RNA test result at screening that satisfies previously listed criteria, they should be referred for standard of care testing and return at a later date for screening.\n\n* Has normal, Grade 1, or Grade 2 results for all the following laboratory tests at screening (i.e., within 28 days prior to entry) based on grading per the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events:\n\n  * AST (\\\u003C5.0 x ULN)\n  * ALT (\\\u003C5.0 x ULN)\n  * Total bilirubin (\\\u003C2.6 x ULN)\n  * Lipase (\\\u003C3 x ULN)\n  * Estimated glomerular filtration rate (eGFR; ≥60 ml\u002Fmin\u002F1.73 m2)\n  * Platelets (≥50,000 cells\u002Fmm3 or ≥50.00 x 109 cells\u002FL)\n  * Hemoglobin (≥8.5 g\u002FdL or ≥5.25 mmol\u002FL)\n  * Neutrophils (≥600 cells\u002Fmm3)\n\nNote: Laboratory tests may be repeated during the study screening period (i.e., within 28 days prior to entry), with the latest result used for eligibility determination. ALT and total bilirubin should also be assessed\n\n* Has no evidence of chronic hepatitis B infection based on hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), and hepatitis B surface antibody (HBsAb) testing at screening; any of the following three combinations of test results are acceptable for inclusion:\n\n  * HBsAg negative, HBcAb negative, HBsAb negative\n  * HBsAg negative, HBcAb negative, HBsAb positive\n  * HBsAg negative, HBcAb positive, HBsAb positive\n* At screening, has a mean QTc interval (based upon a triplicate reading) less than or equal to 450 msec based on an electrocardiogram (ECG) automated machine readout or calculated using the Fridericia formula.\n* For female participants of childbearing potential, not pregnant based upon negative blood or urine pregnancy test at entry. Childbearing potential is defined as nine years of age or older and:\n\n  * Having reached menarche or\n  * Engaging in sexual activity (self-reported) that could lead to pregnancy\n* For female participants of childbearing potential who are engaging in sexual activity (self-reported) that could lead to pregnancy, at entry, currently using at least one allowable highly effective method of contraception and agrees to use at least one allowable highly effective method of contraception throughout study participation and for at least 30 days after last oral product use and 48 weeks after last injectable study product use.\n\nHighly effective methods of contraception include:\n\n* Surgical sterilization (i.e., hysterectomy, bilateral oophorectomy, tubal ligation, or salpingectomy)\n* Contraceptive intrauterine device or intrauterine system\n* Subdermal contraceptive implant\n* Progestogen injections\n* Combined estrogen and progestogen oral contraceptive pills\n* Percutaneous contraceptive patch\n* Contraceptive vaginal ring\n\nInclusion Criteria, Step 2: Continuation for Cohort 1 and Cohort 2a to injection phase\n\nAll participants enrolled in Cohort 1 or Cohort 2a will be assessed for eligibility to progress from the oral lead-in phase (Step 1) to the injection phase (Step 2), primarily based on the safety assessments from the Step 1 Week 4a study visit. Clinical assessments conducted prior to administering the first injection at the Week 4b visit will also be used to confirm eligibility to receive the injectable study product.\n\nAll of the following criteria must be met in order for a participant enrolled in Cohort 1 or Cohort 2a to be included in Step 2\n\n* Currently enrolled as a participant in Step 1.\n* Has normal, Grade 1, or Grade 2 results from all of the following laboratory test results based upon specimens collected at the Week 4a study visit or from confirmatory repeat testing of Week 4a study visit laboratory tests:\n\n  * AST (\\\u003C5.0 x ULN)\n  * ALT (\\\u003C5.0 x ULN)\n  * Lipase (\\\u003C 3 x ULN)\n  * Estimated glomerular filtration rate (eGFR; ≥60 ml\u002Fmin\u002F1.73 m2))\n  * Platelets (≥50,000 cells\u002Fmm3 or ≥50.00 x 109 cells\u002FL)\n  * Hemoglobin (≥8.5 g\u002FdL or ≥5.25 mmol\u002FL)\n  * CK (\\\u003C10 x ULN)\n\nNote: For a Grade 2 ALT test result from this visit, refer to protocol for required participant management.\n\n* For female participants of childbearing potential not pregnant based upon negative blood or urine pregnancy test at the Week 4b study visit.\n* Assessed by the IoR or designee as sufficiently adherent to study products in Step 1 to permit an adequate evaluation of safety and tolerability as part of the oral lead in phase prior to entry into the injection phase.\n\nInclusion Criteria for Parents\u002FCaregivers\n\nParents\u002Fcaregivers of participants will be considered for enrollment to complete quantitative behavioral surveys and\u002For qualitative in-depth interviews (IDIs), as indicated in the SoE. One parent\u002Fcaregiver per participant should be enrolled to complete all behavioral assessments, including the IDI, when applicable. Informed consent for parent\u002Fcaregiver enrollment should be obtained at the entry visit, after the child participant's eligibility has been confirmed, and may be completed at a later date, if necessary. However, parent\u002Fcaregiver consent must occur prior to any study assessments being conducted. The enrolled caregiver may be the different than the parent or legal guardian who provided written permission for the child to participate. If, at any point the enrolled parent\u002Fcaregiver for a given participant withdraws from the study or is unable to complete remaining study assessments for any reason, they may be replaced.\n\nCaregivers must meet the following criteria to be eligible to enroll in IMPAACT 2036:\n\n* 18 years of age or older\n* Able and willing to provide written informed consent consistent with site IRB\u002FEC policies and procedures\n* Caregiver, defined as a biological parent, legal guardian, or other person who provides significant emotional, psychological, and\u002For physical care to a child enrolled in IMPAACT 2036, based on self-report\n\nExclusion Criteria, Step 1: Entry for Cohort 1, Cohort 2a, and Cohort 2b\n\nPotential participants must be excluded from the study if any of the conditions specified below are identified during the screening period (i.e., within 28 days prior to study entry). The screening period begins when parental permission and informed assent (if applicable) are obtained and ends immediately prior to enrollment. For criteria involving a potential participant's medical history, it is expected that each exclusionary condition will be assessed at screening and subsequently reviewed and confirmed on the day of study entry, prior to enrollment. In these criteria, \"at entry\" is used to refer to the day of enrollment in the study\n\n* Within 6 months prior to entry, any HIV-1 RNA value \\>400 copies\u002FmL OR two consecutive \"viral blips,\" defined as an HIV-1 RNA value ≥50 copies\u002FmL but ≤400 copies\u002FmL.\n* As determined by the IoR or designee, and based on available medical records, known or suspected resistance to NNRTIs.\n\nNote: Prior receipt of NNRTIs for prophylaxis or treatment is not exclusionary\n\n* As determined by the IoR or designee, and based on available medical records, known or suspected resistance to INSTIs.\n* Ongoing congestive heart failure, symptomatic arrhythmia, or any current clinically significant cardiac disease, as determined by the IoR or designee, and based on available medical records.\n* Has any of the following, as determined by the IoR or designee based on participant\u002Fparent\u002Fguardian report and available medical records:\n\n  * Current hepatitis C infection\n  * Current clinically significant hepatic disease\n  * Current or anticipated need for chronic anti-coagulation\n  * History of known or suspected bleeding disorder, including a history of prolonged bleeding\n  * History of sensitivity to heparin or heparin-induced thrombocytopenia, as determined by the IoR or designee, based on available medical records\n  * Risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, hypomagnesemia)\n  * Known or suspected allergy to study product components.\n  * Known phobia to needles\n* More than one seizure within one year (defined as within 365 days) prior to entry, or unstable or poorly controlled seizure disorder, as determined by the IoR or designee, and based on available medical records.\n* Has the following combination of laboratory test results at screening (i.e., from specimens collected within 28 days prior to entry): ALT greater than or equal to 3 x ULN and total bilirubin greater than or equal to 1.5 x ULN and direct bilirubin greater than 35% of total bilirubin.\n* At entry, known active tuberculosis infection, as determined by the IoR or designee based on participant\u002Fparent\u002Fguardian report and available medical records.\n* At entry, any ongoing pancreatitis as determined by the IoR or designee based on participant\u002Fparent\u002Fguardian report and available medical records.\n* At entry, has symptoms suggestive of active coronavirus disease 2019 (COVID-19) or test results or contacts that require quarantine per local clinical practice, public health, and\u002For infection control guidelines as determined by the IoR or designee based on participant\u002Fparent\u002Fguardian report and available medical records.\n\nNote: Potential participants with symptoms suggestive of active COVID-19, test results, and\u002For contacts that require quarantine may resume screening (or be re-screened) after symptoms have resolved and applicable quarantine requirements have been completed.\n\n* Receipt of any prohibited medication within 7 days prior to entry, with the exception of antiviral agents that are part of the participant's ART regimen, as determined by the site investigator based on participant\u002Fparent\u002Fguardian report and available medical records\n\nNote: Medications and vaccines approved for emergency use (e.g., COVID vaccines) that do not appear in the IMPAACT 2036 Prohibited and Precautionary Medications listing are not exclusionary may be administered as per standard of care.\n\n* Any past or current exposure to CAB LA or RPV LA\n* At entry, based on physical examination, has a current inflammatory skin condition that compromises the safety of intramuscular injections, as determined by the IoR or designee.\n* At entry, based on physical examination, has a dermatological condition overlying the buttock or upper thigh region, which, in the IoR or designee's opinion, may interfere with the interpretation of injection site reactions.\n* Enrolled in another clinical trial of an investigational agent, device, or vaccine.\n* Has any documented or suspected clinically significant medical or psychiatric condition or any other condition or social circumstance that, in the opinion of the site investigator, would make participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.\n\nExclusion Criteria, Step 2: Continuation for Cohort 1 and Cohort 2a to injection phase\n\nParticipants in Cohort 1 or Cohort 2a who meet any of the following criteria will be excluded from Step 2:\n\n* Has permanently discontinued oral study product.\n* Occurrence of any grade 3 or higher adverse event assessed as related to study product during Step 1.\n* Any other condition or social circumstance situation that, in the opinion of the IoR or designee, would make continued study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.\n\nExclusion Criteria for Parents\u002FCaregivers\n\n* Any condition or social circumstance situation that, in the opinion of the IoR or designee, would make study participation unsafe for the caregiver or the child study participant, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.","2 Years","11 Years",{"count":277,"type":23},90,[89,201],"The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a long-acting injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to Less Than 12 Years of Age",[92],"2026-05-18",{"date":283,"type":49},"2026-05-19",{"date":285,"type":49},"2024-01-24",{"date":287,"type":23},"2029-03-31",{"name":163,"class":164},{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":18,"minAge":296,"maxAge":297,"enrollmentInfo":298,"targetDuration":4,"studyType":24,"phases":300,"briefSummary":301,"conditions":302,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":315},"100558714","phase-2-tesamorelin-as-an-adjunct-to-exercise-for-improving-physical-function-in-hiv-100558714","NCT06554717","Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV","TRIUMPH","Inclusion Criteria:\n\n1. Men and women, 50-80 years old\n2. Documented HIV infection on suppressive antiretroviral therapy for at least 1 year with HIV-1 RNA \\\u003C200 copies\u002FmL and CD4+ T cell count \\>200\u002FµL 3\n3. Sedentary lifestyle, defined as self-reported physical activity that breaks a sweat \\\u003C3 days\u002Fweek with no regular resistance exercise in the past 3 months\n4. ≥1 Fried frailty criterion (weakness, slow gait speed, exhaustion, decreased physical activity, or unintentional weight loss as defined by specific thresholds)\n5. Excess abdominal adiposity as indicated by at least one of the following elevated anthropometric measures assessed at Screen: (1) waist circumference ≥102 cm in non-Asian males (≥90 cm in Asian males) or ≥88 cm in non-Asian females (≥80 cm in Asian females); (2) waist-to-hip ratio ≥0.9 in males or ≥0.85 in females; (3) waist-to-height ratio ≥0.5 in males and females\n6. Normal mammogram within 2 years (females ≤74 years old) or prostate specific antigen \\\u003C4 ng\u002FmL (males ≤70 years old) per U.S. Preventive Services Task Force (USPSTF) age-appropriate cancer screening guidelines\n7. For females, postmenopausal defined as no menses for ≥12 months and anti-müllerian hormone (AMH) \\\u003C20 pg\u002FmL or history of bilateral oophorectomy at least 3 months ago\n8. Provider approval to participate\n\nExclusion Criteria:\n\n1. Use of tesamorelin or other growth hormone (GH)-based therapy within 6 months\n2. Insulin-like growth factor 1 (IGF-1) z-score \\>2.0\n3. HbA1c \\>8%\n4. Active or suspected malignancy (with the exception of non-melanoma skin cancer) within 24 months\n5. Supraphysiologic testosterone or corticosteroid exposure, or change in exogenous testosterone or corticosteroid dose within 3 months\n6. Change in glucose-lowering medication (e.g., glucagon-like peptide-1 receptor agonists) within 3 months\n7. Active or unstable coronary artery disease, chest pain suspicious for angina, or serious arrythmia\n8. History of hypopituitarism, head irradiation, or other conditions known to affect the GH\u002FIGF-1 axis\n9. Known hypersensitivity to tesamorelin or mannitol\n10. Acute or chronic illness judged by the investigator to represent a contraindication to study participation","50 Years","80 Years",{"count":299,"type":23},100,[201],"People with HIV experience earlier impairments in physical function compared to people in the general population. They also exhibit an earlier presentation and more rapid development of frailty, a multisystemic syndrome of aging characterized by reduced activity, fatigue, slowness, weakness, and weight loss. While exercise can improve physical function in people with HIV, it is less effective in doing so than in the general population and is difficult to sustain in the long-term.\n\nThe goal of this clinical trial is to learn whether the medication tesamorelin will improve physical function and muscle health in adults with HIV when combined with exercise. Tesamorelin is a growth hormone-releasing hormone analogue that is FDA-approved to treat abdominal fat accumulation in people with HIV. While tesamorelin has also been shown to increase muscle mass and improve measures of muscle health, its effects on physical performance and muscle strength have not yet been evaluated.\n\nDuring a 24-week intervention phase, half of participants will be randomly assigned to receive tesamorelin and half of participants will be randomly assigned to receive placebo (a look-alike substance that contains no drug). All participants also will engage in a home-based exercise intervention supervised by an exercise coach. During a subsequent 24-week extension phase, individuals will be monitored off study drug and supervised exercise, and be encouraged to continue to exercise independently.\n\nThe investigators will investigate effects of tesamorelin on physical function, muscle mass and quality, quality of life, and exercise adherence and self-efficacy. They also will evaluate whether effects of tesamorelin are maintained following treatment cessation. This study may identify an important strategy to improve how individuals aging with HIV function and feel with potential applications to other patient populations.",[92,303,304,305,306],"Frailty","Impaired Physical Function","Abdominal Obesity","Aging","2026-05-15",{"date":283,"type":49},{"date":310,"type":49},"2025-07-10",{"date":312,"type":23},"2028-12-01",{"name":314,"class":56},"Massachusetts General Hospital",2,{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":326,"phases":4,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":333,"leadSponsor":335,"locationsCount":4},"100638908","persistance-of-long-acting-injectable-cabrpv-in-a-cohort-of-virologically-suppressed-plwh-a-real-life-study-100638908","NCT07579546","PERsistance of Long-Acting inJEctable CAB+RPV in a Cohort of Virologically-suppressed PLWH: a Real-life Study","Evaluating Persistence of Switching From Oral RPV\u002FFTC\u002FTAF to Long- Acting Injectable CAB+RPV in a Cohort of Virologically-suppressed PLWH: a Real-life Study","PERLAJE","Inclusion Criteria:\n\n* Age ≥ 18 years\n* HIV infection\n* Virologically suppression (defined as VL\\\u003C50 copies\u002FmL in at least two consecutive determinations with a minimum interval of at least two months±2weeks between each determination)\n* Informed consent form signed\n\nExclusion Criteria:\n\n* none",{"count":325,"type":23},200,"OBSERVATIONAL","People living with HIV (PLWH) need to take antiretroviral therapy (ART) long-life. The development of new and more effective ART regimens has increased viral suppression and improved the recovery of immune function, leading to an extension of the lifespan of PLWH. However, antiretroviral drugs have short- and long-term side effects. In fact, ART has recently been reported as one of the significant factors associated with metabolic syndromes (obesity, liver disease, and factor). This insidious progression of long-term metabolic complications has become a new challenge for our clinics. Therefore, optimizing ART in the context of viral suppression is mandatory. In recent years, thanks to the availability of more potent drugs with a high genetic barrier, simplification strategies have been explored with various regimens containing fewer drugs for PLWH who are virologically suppressed on a standard three-drug regimen. Based on international guidelines, following the results of clinical trials, two-drug regimens are now recommended as pro-active switch strategies within preventive strategies to reduce morbidity in PLWH. Following the results of the ATALS-2M, FLAIR, and SOLAR studies, the long-acting parenteral regimen containing cabotegravir and rilpivirine (CAB+RPV), administered every 2 months, has been included in the guidelines as a pro-active switch strategy for maintaining virological suppression. Cabotegravir, a new integrase inhibitor (INI), has demonstrated high efficacy, excellent tolerability, and safety, with a higher-than-average genetic barrier.\n\nRilpivirine is a non-nucloside reverse transcriptase inhibitor (NNRTI) with potent virological efficacy and a favorable safety profile compared to other NNRTIs. This type of strategy has several primary advantages: improve adherence, especially in complex PLWH, easier to integrate into daily activities, less likely to generate stigma and\u002For discrimination.\n\nFurthermore, intramuscular administration, bypassing intestinal metabolism, potentially reduces the severity of drug-drug interactions. In light of the growing attention to the metabolic impact of various antiretroviral therapy regimens and their associated adverse events, it is crucial to examine the tolerability of this injectable regimen as a medium- and long-term switching strategy. The results of the Phase 3 studies are based on populations with a short exposure to antiretroviral drugs, which may not be generalized to PLWH with a long history of ART, who represent the majority of patients in clinical practice in high-income countries. This study aims, in a clinical practice setting, to evaluate the cumulative probability of treatment discontinuation (TD) at 48 weeks in PLWH switching to the injectable LA CAB + RPV (LAI CAB + RPV) regimen from an oral regimen with rilpivirine\u002Femtricitabine\u002Ftenofovir alafenamide fumarate (RPV + FTC + TAF).",[92],"2026-05-05",{"date":331,"type":49},"2026-05-12",{"date":260,"type":23},{"date":334,"type":23},"2027-06-01",{"name":336,"class":56},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":84,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":24,"phases":346,"briefSummary":347,"conditions":348,"keywords":353,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":364},"100636255","a-study-to-evaluate-performance-usability-and-contrived-result-interpretation-of-truplex-hivhepbsyphilis-rapid-test-100636255","NCT07563309","A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV\u002FHepB\u002FSyphilis Rapid Test","A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of TruPlex HIV\u002FHepB\u002FSyphilis Rapid Test by Trained Personnel at Near-Patient and Point-of-Care Settings","Inclusion Criteria:\n\n* 18 years of age or older\n* Subject is able to provide and willing to sign and date the Informed Consent Form\n* Subject is able to complete the required testing on the allocated testing day.\n* Subject able to speak\u002Fread\u002Fwrite English or a translator is available\n* Subject is getting tested for HIV, and\u002For Syphilis, and\u002For Hepatitis B for one or more of the following reasons:\n\n  * At risk for any one of the target diseases\n  * Having signs or symptoms indicative of the target diseases\n  * Routine testing\n  * Note: Subjects who are pregnant and re-infected are eligible to participate\n* Unknown HIV or known HIV positive status with less than 12 months of Anti-Retroviral Treatment (ART).\n* Subject is willing to provide the fingerstick blood sample(s) and whole blood samples collected through venous blood draw (approximately 16 ml) required for the study.\n* Subject willing to participate in the study site's standard of care counselling and testing program and receive the study site's standard of care test results\n\nExclusion Criteria:\n\n* Subject has a bleeding disorder\n* Subject is currently undergoing Syphilis treatment\n* Subject has received any experimental HIV vaccine\n* Subject received HBV vaccine within the last 7 days\n* Known HIV positive subjects and currently on ART for 12 months or longer\n* Any condition which, in the opinion of the Investigator, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of study assessment, consent form and questionnaire etc. or bias the study outcome.",{"count":345,"type":23},1000,[26],"The objectives of this study are as follows:\n\nTo evaluate the clinical performance of the TruPlex test using capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care settings\n\nTo evaluate the usability of the TruPlex test through:\n\nStructured usability assessments, via a questionnaire, completed by trained operators in point-of-care settings.\n\nTo assess user interpretation accuracy through a contrived result interpretation questionnaire, where intended users evaluate a set of pre-defined test results (e.g., strong\u002Fweak positives, negatives, invalids).\n\nTo monitor test system reliability, including invalid rates.",[349,350,351,352],"HIV 1 Infection","HIV 2 Infection","Syphilis Infection","Hepatitis B Infection",[354],"TruPlex HIV\u002FHepB\u002FSyphilis Rapid Test","2026-04-29",{"date":357,"type":49},"2026-05-04",{"date":359,"type":49},"2025-12-18",{"date":361,"type":23},"2027-01-01",{"name":363,"class":189},"bioLytical Laboratories",3,{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":24,"phases":374,"briefSummary":375,"conditions":376,"keywords":378,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":57},"100375918","semaglutides-efficacy-in-achieving-weight-loss-for-those-with-hiv-100375918","NCT04174755","Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV","SWIFT","Inclusion Criteria:\n\n* Be over 18 years old\n* Be HIV-1 antibody positive as determined by a positive 4th generation Ag\u002FAb ELISA assay\n* Be stable on ART with a viral load suppressed \\\u003C40 copies\u002FmL for a minimum of 2 years\n* Have a CD4 count ≥200 cells\u002Fmm3 for a minimum of 1 year\n* Have a BMI ≥30kg\u002Fm2 or have a BMI ≥27kg\u002Fm2 and hypertension, dyslipidaemia or type 2 diabetes mellitus\n* Understand the study procedures, be able to comply with the study procedures, and voluntarily agree to participate by giving written informed consent for the trial\n\nExclusion Criteria:\n\n* Subjects unable to comply with the study protocol or unable to self-administer subcutaneous semaglutide\n* History of obesity induced by other endocrine disorders: hypothyroidism, Cushing's syndrome, primary and secondary hypogonadism, hypothalamic disorders, polycystic ovary syndrome, insulinoma\n* History of obesity induced by use of anti-psychotic medications known to be associated with weight gain (i.e. olanzapine, clozapine).\n* Treatment with GLP-1 receptor agonists (including liraglutide, semaglutide or exenatide), dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months (including saxagliptin, linagliptin, sitagliptin)\n* History of severe renal impairment, as defined by a baseline creatinine clearance \\\u003C30ml\u002Fmin\n* Individuals with a diagnosis of HIV-associated lipoatrophy\u002Flipodystrophy, based on physician's assessment\n* Individuals with severe hepatic impairment (Child Pugh score \\>9)\n* Subjects with active hepatitis B infection (defined as hepatitis B sAg positive) or hepatitis C (defined as hepatitis C Ab and RNA positive) co-infection\n* Any active illness (including AIDS-defining illness) which in the opinion of the investigator precludes participation in the study\n* History of cancer (apart from treated Kaposi's Sarcoma) and\u002For receiving chemotherapy or radiotherapy\n* Active illicit intravenous drug use\n* Subjects concurrently enrolled in another clinical trial of an investigational medicinal product.\n* The investigator may decide that a subject cannot proceed in the study if there is any relevant other abnormal results in the screening assessments\n* Subjects with any known or suspected hypersensitivity to semaglutide or any of the excipients of semaglutide\n* Subjects on another medicinal product prescribed primarily for weight loss e.g. orlistat (see prohibited\u002Fcautioned concomitant medications\u002Ftherapies section)\n* For female subjects: pregnancy or breastfeeding at screening, planning future pregnancies or unwilling to take measures to avoid pregnancy for the duration of the study",{"count":373,"type":23},80,[26],"The prevalence of obesity is rising worldwide, both in low- and high-income countries, including people with HIV (PWH). Semaglutide's efficacy in achieving weight loss in obese PWH is still unexplored. The aim of this study is to assess the efficacy and safety of semaglutide in achieving greater weight loss compared to diet and excercise alone in obese PWH and to explore the effect of semaglutide on the immune function, markers of immune activation, viral reservoir, markers of glucose and lipid metabolism and gut microbiome.",[377,92],"Obesity",[379,35,380,381,382,383,384],"obesity","weight loss","GLP-1 analogue","immune activation","viral reservoir","gut microbiome","2026-04-28",{"date":355,"type":49},{"date":388,"type":49},"2022-06-22",{"date":390,"type":23},"2027-07",{"name":392,"class":56},"University College Dublin",{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":84,"sex":18,"minAge":19,"maxAge":399,"enrollmentInfo":400,"targetDuration":4,"studyType":24,"phases":402,"briefSummary":404,"conditions":405,"keywords":406,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":57},"100430298","early-phase-1-cannabis-use-cognition-and-the-endocannabinoid-system-in-hiv-100430298","NCT04883255","Cannabis Use, Cognition, and the Endocannabinoid System in HIV","Inclusion Criteria\n\n1. Aged 18-65\n2. Possess the capacity to provide informed consent to a set of neurobehavioral, neuromedical and cognitive assessment procedures. Individuals unable to provide such consent will not be enrolled into the study.\n3. Willing to confirm self-reported HIV using a rapid test: HIV status will be determined using the MedMira Rapid Test (Halifax, Nova Scotia, Canada). If the result differs from the participant's self-report a confirmatory Western Blot will be performed.\n4. Willing to abstain from cannabis for at least 1 week prior to the baseline visit and during the study. Although there is no definitive method for determining abstinence over this period, abstinence will be confirmed as best as possible by using an oral fluid testing device (Draeger 5000) employed by law enforcement officers to detect recent cannabis use. An oral fluid value of \\> 5ng suggests recent use, although in some cases it has been reported that individuals may show \\> 5ng up to 20 hours after use. Thus, should the oral fluid sample indicate \\> 5ng THC, the assessment may be canceled and rescheduled.\n\nExclusion Criteria\n\n* Inability to provide informed consent\n* Significant chronic renal disease (unrelated to HIV), significant chronic pulmonary disease (unrelated to HIV), or Hepatitis C Virus infection\n* Head injury with loss of consciousness for greater than 30 minutes or resulting in neurologic complications\n* Seizure disorder\n* Demyelinating diseases or other non-HIV neurological disorders\n* Pregnancy\n* Acute or recent or previous clinically disabling stroke or previous cerebrovascular events\n* Lifetime history of schizophrenia or other psychotic disorders, or bipolar disorder.\n* Beck Depression Inventory-II (BDI-II) score is greater than or equal to 29 (severe depression) or suicidal ideas are endorsed on the BDI-II or a Center for Epidemiological Studies-Depression Scale (CES-D) subscale measuring suicidal ideation\n* Substance use disorder (mild, moderate or severe) within the last 12 months","65 Years",{"count":401,"type":23},138,[403],"EARLY_PHASE1","Understanding how co-morbidities in persons with HIV (PWH) such as substance use affect risk-taking, decision-making, and other cognitive behaviors is important given implications for everyday functioning and transmission risk. The high prevalence of cannabis use in PWH, medicinally and recreationally, may indicate disease severity, impart therapeutic benefits, or adverse consequences. In fact, cannabis is recommended to those with HIV to alleviate nausea, improve appetite, relieve pain, and lift mood. To-date, the consequences of cannabis use in PWH remain unclear as do potential interactions with HIV treatments. In healthy participants, heavy cannabis use is associated with cognitive deficits e.g., risky decision-making, response disinhibition and inattention, but pro-cognitive effects in PWH may exist at mild use levels due to its anti-inflammatory and anti-excitotoxic properties. Furthermore, little has been done to determine the effects of cannabis use on the endocannabinoid (EC) system in general or in PWH. This study will determine the effects of the two primary cannabis constituents (Δ9-tetrahydrocannabinol \\[THC\\], cannabidiol \\[CBD\\]) vs. placebo on risky decision-making, response inhibition, reward learning, temporal perception, and motivation, plus EC and homovanillic acid (HVA; a surrogate for dopamine activity) levels in HIV+ and HIV- subjects. Participants with infrequent cannabis use will undergo baseline cognitive testing and biomarker assays with antiretrovirals (ART) use quantified. They will be randomized to a 5-day course of either THC, CBD, or placebo and return for follow-up testing and re-assaying of ECs and HVA levels.",[92],[407,35,408,409],"cannabis","THC","cannabidiol","2026-04-27",{"date":412,"type":49},"2026-05-01",{"date":414,"type":49},"2023-05-03",{"date":416,"type":23},"2026-06-30",{"name":418,"class":56},"University of California, San Diego",{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":426,"enrollmentInfo":427,"targetDuration":4,"studyType":24,"phases":428,"briefSummary":429,"conditions":430,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":439},"100573651","phase-2-evaluation-of-long-acting-lenacapavir-for-the-treatment-of-hiv-1-in-treatment-experienced-adolescents-and-children-100573651","NCT06749054","Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children","A Phase 2, Open-label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Long-Acting Lenacapavir in Combination With an Optimized Background Regimen in Treatment-experienced Adolescents and Children With HIV-1","Key Inclusion Criteria:\n\n* Body weight at screening ≥ 35 kg.\n* On a stable failing antiretroviral (ARV) regimen for \\> 8 weeks before screening and willing to continue the regimen until Day 1.\n* Plasma HIV-1 RNA ≥ 400 copies\u002FmL on at least 2 consecutive occasions spanning at least 6 months, including at screening.\n* Have previously changed their ARV regimen due to treatment failure.\n* ARV treatment options limited due to resistance, tolerability, contraindications, safety, drug access.\n* Able and willing to commit to taking LEN in combination with their OBR.\n* The following laboratory parameters at screening:\n\n  1. Estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2 using Bedside Schwartz Formula.\n  2. Absolute neutrophil count \\> 0.50 GI\u002FL (\\> 500 cells\u002Fmm\\^3).\n  3. Hemoglobin ≥ 85 g\u002FL (\\> 8.5 g\u002FdL).\n  4. Platelets ≥ 50 GI\u002FL (≥ 50,000\u002Fmm\\^3).\n  5. Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) ≤ 5 × upper limit of normal.\n  6. Total bilirubin ≤ 23 μmol\u002FL (≤ 1.5 mg\u002FdL) and direct bilirubin ≤ 7 μmol\u002FL (≤ 0.4 mg\u002FdL).\n\nKey Exclusion Criteria:\n\n* Life expectancy ≤ 1 year.\n* An opportunistic illness requiring treatment within the 30 days prior to screening.\n* Evidence of active pulmonary or extra-pulmonary tuberculosis within 3 months prior to screening.\n* Hepatitis C virus (HCV) antibody positive with detectable HCV RNA at screening.\n* Hepatitis B virus (HBV) surface antigen (HBsAg) positive or HBV core antibody (antibody against hepatitis B core antigen (anti-HBc)) positive; if individual is HBsAg negative and anti-HBc positive but HBV DNA undetectable, individual may be enrolled.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","17 Years",{"count":239,"type":23},[201],"The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN). The study will assess the safety, tolerability, and efficacy of long-acting LEN when combined with other medicines in adolescents and children living with HIV-1 who weigh at least 35 kg and have been treated before for HIV-1. The study will also see how easy it is for participants to take LEN as injection or an oral pill.\n\nThe primary objectives are to evaluate the pharmacokinetics and safety of LEN in combination with optimized background regimen (OBR) in TE pediatric participants with HIV-1.",[92],"2026-04-22",{"date":433,"type":49},"2026-04-24",{"date":435,"type":49},"2025-03-26",{"date":437,"type":23},"2027-09",{"name":188,"class":189},9,{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":446,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":24,"phases":449,"briefSummary":450,"conditions":451,"keywords":454,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":266},"100629566","phase-4-reinitiation-of-antiretroviral-therapy-using-oral-bictegravir-emtricitabine-and-tenofovir-alafenamide-100629566","NCT07476339","REINItiation of Antiretroviral Therapy Using Oral bicTegravir, emtrIcitAbine and Tenofovir alafenamidE","A Multi-Center, Single-Arm, Open-Label, Prospective, Phase 4 Study to Investigate the Safety and Efficacy of Rapidly Restarting Oral Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B\u002FF\u002FTAF) in Viremic and Virologically-Suppressed Male and Female HIV-Positive Patients Aged ≥18 Years Who Are Treatment-Experienced and Returning to Care After Experiencing a Treatment Interruption of ≥12 Weeks","REINITIATE","Inclusion Criteria:\n\n* ≥18 years of age at the time of signing the informed consent form (ICF)\n* Diagnosis of HIV-1 confirmed by any positive HIV 4th generation test or detectable HIV-1 RNA level in \\>6 months\n* Previously received ART for ≥30 consecutive days, as self-reported\n* No ART dose received for ≥12 weeks prior to provision of informed consent, by any route of administration (i.e., injection or oral), as self-reported\n* Returning to care with an interest to restart ART therapy\n* Body weight ≥25 kg\n* Signed ICF which includes compliance with the requirements and restrictions listed in ICF and study protocol\n\nExclusion Criteria:\n\n* Diagnosis of HIV-2 infection\n* Known or suspected history of severe hepatic impairment (Child-Pugh Class C)\n* Known or suspected history of severe renal impairment (estimated creatinine clearance \\[eCrCl\\] \\\u003C30 mL\u002Fmin)\n* Concomitant medication that is contraindicated with B\u002FF\u002FTAF\n* Known or suspected resistance to BIC (resistance-associated mutations (RAMs) include: T66A\u002FI\u002FK, E92G\u002FQ, G118R, F121Y, Y143C\u002FH\u002FR, S147G, Q148H\u002FK\u002FR, N155H\u002FS, or R263K in the integrase gene)\n* Known\u002Fsuspected resistance to TFV (RAMs include: K65R\u002FE\u002FN, or K70E)\n* Known\u002Fsuspected history of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F\u002FY, and K219Q\u002FE\u002FN\u002FR), T69-insertions, or K65R\u002FE\u002FN in RT\n* History of B\u002FF\u002FTAF intolerance\n* Unable to swallow whole tablets or swallow tablets cut into halves\n* Unable to communicate in either English or Spanish",{"count":325,"type":23},[177],"Managing HIV well requires taking antiretroviral therapy (ART) every day, but many people living with HIV experience interruptions in their treatment. These pauses in medication can happen for many reasons, such as side effects, challenges with getting to the clinic, personal circumstances, stigma, or difficulties with everyday life. When HIV treatment is stopped, the viral load can increase, which may affect a person's health and make it easier for HIV to be passed on to others. Restarting treatment quickly after an interruption is important for both personal and public health. However, it can be difficult for people who miss doses to get back on treatment right away. There are often several steps and medical appointments required before restarting, such as waiting for lab results or reviewing medical history, which can cause further delays. These additional steps can make it even harder for people to re-engage and may discourage them from returning to care.\n\nThe REINITIATE study is designed for people living with HIV who have not taken any antiretroviral medications for at least the last 12 weeks. The study will offer participants a way to restart their HIV therapy quickly, by beginning treatment with B\u002FF\u002FTAF on the same day that they return to care. B\u002FF\u002FTAF is a widely used, once-daily HIV regimen, and is recommended in national treatment guidelines.\n\nResearchers want to find out if this rapid restart approach is safe and effective, and whether it helps people regain control of HIV and remain in care. The study will also examine how many participants are able to keep the virus at a low level (viral suppression), stay engaged in their HIV care, and tolerate the medication after rapidly restarting treatment. In addition, the study will include interviews with some participants, to gain a better understanding of why they stopped taking their medications and what supported their return to treatment. These insights could help healthcare teams develop better ways to support people living with HIV in the future.",[452,453,35,349],"HIV -1 Infection","HIV (Human Immunodeficiency Virus)",[120,455,456,457,458,118,459,460,461,462,463,464,465,466,467],"HIV Infections","Bictegravir","Emtricitabine","Tenofovir Alafenamide","Antiretroviral Therapy, Highly Active","Treatment Interruption","Virologically Suppressed","Treatment-Experienced","Returning to Care","Phase 4","B\u002FF\u002FTAF","B\u002FF\u002FTAF; bictegravir, emtricitabine, tenofovir alafenamide, drug combination","Rapid Restart","2026-03-26",{"date":470,"type":49},"2026-03-31",{"date":472,"type":23},"2026-03-23",{"date":474,"type":23},"2026-10-23",{"name":476,"class":56},"CAN Community Health",{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":481,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":84,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":326,"phases":4,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":500},"100615511","understanding-practices-of-lactation-and-infant-feeding-together-with-women-with-hiv-in-the-united-states-100615511","NCT07293559","Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States","UPLIFT","Core Activity 1 Inclusion Criteria: Pregnant and Postpartum Women with HIV\n\n* Is of legal age or circumstance to provide independent informed consent\n* Belongs to one of the following five categories:\n\n  * Is pregnant with a gestational age of 28 0\u002F7 to 37 6\u002F7 weeks at entry and is considering breastfeeding\n  * Is pregnant with a gestational age of 28 0\u002F7 to 37 6\u002F7 weeks at entry and is not considering breastfeeding\n  * Gave birth to a live born infant after 28 February 2023, is over 4 weeks postpartum, did not breastfeed for any duration and has no intent to breastfeed\n  * Gave birth to a live born infant after 28 February 2023, is over 4 weeks postpartum, breastfed for less than four weeks, and has weaned\n  * Gave birth to a live born infant after 28 February 2023, is over 4 weeks postpartum, and breastfed for four weeks or longer\n* Diagnosed with HIV prior to or during the pregnancy\n* If preferred language is other than English, is willing to participate in interviews with an available translator.\n\nCore Activity 1 Inclusion Criteria: Healthcare Providers and Ancillary Healthcare Professionals\n\n* Is of legal age or circumstance to provide independent informed consent\n* Is a healthcare provider who self-identifies as an obstetrician, midwife, nurse, adult or pediatric infectious disease specialist, or advance practice provider who participated in the care of at least five PPWH and\u002For their infants over the three years prior to entry OR\n* Is an ancillary healthcare professional who self-identifies as a social worker, lactation support provider, patient navigator, pharmacist, doula who participated in the care of at least five PPWH and\u002For their infants over the three years prior to entry\n\nCore Activity 1 Inclusion Criteria: Influential Individuals\n\n* Has been identified by a PPWH enrolled in Core Activity 1 as aware of her HIV status and contributing to her infant feeding decisions\n* Is of legal age or circumstance to provide independent informed consent\n* If preferred language is other than English, is willing to participate in interviews with an available translator.\n\nCore Activity 2 Inclusion Criteria: Pregnant and Postpartum Women with HIV and their Infant\n\n* Is of legal age or circumstance to provide independent informed consent\n* Is pregnant with singleton fetus with a gestational age of ≥ 28 0\u002F7 weeks at entry OR\n* Gave birth to a live born, singleton infant up to 7 days prior to entry\n* Diagnosed with HIV prior to or during the pregnancy\n* Expected to be available for the duration of follow-up\n\nCore Activity 3 Inclusion Criteria: Breastfeeding Postpartum Women with HIV and their Infant\n\n* Is of legal age or circumstance to provide independent informed consent\n* Must be up to 7 days postpartum with live-born infant\n* Diagnosed with HIV prior to or during the pregnancy\n* Breastfed her infant for any duration\n\nCore Activity 3 Inclusion Criteria: Pilot Registry Testers\n\n* Is of legal age or circumstance to provide independent informed consent\n* Working at a healthcare facility that provides care for women with HIV who are breastfeeding and\u002For their infants\n\nExclusion Criteria: Core Activities 1-3\n\n* Has any condition identified during the screening period that, in the opinion of site investigator, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives",{"count":485,"type":23},1150,"IMPAACT 2046\u002FUPLIFT (Understanding Practices of Lactation and Infant Feeding decisions Together with women with HIV) is a multi-site, mixed-methods, observational cohort study. The purpose of the study is to explore infant feeding preferences, practices, and outcomes among mothers with HIV and their families in the United States. It will employ both qualitative and quantitative research methods to address existing knowledge gaps and to understand the clinical, behavioral, and social factors influencing infant feeding decisions. As part of the study's mixed method approach, a longitudinal cohort study of mothers and their infants will be established. The study also aims to pilot a national registry of breastfeeding women living with HIV in the United States.",[92,488,489],"Breastfeeding","Pregnancy Related","2026-03-25",{"date":492,"type":49},"2026-03-27",{"date":494,"type":49},"2026-02-24",{"date":496,"type":23},"2031-04-24",{"name":498,"class":499},"International Maternal Pediatric Adolescent AIDS Clinical Trials Group","NETWORK",11,{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":24,"phases":510,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":57},"100474528","addressing-barriers-to-anti-hypertensive-medication-adherence-among-plwh-who-have-achieved-viral-suppression-100474528","NCT05459077","Addressing Barriers to Anti-hypertensive Medication Adherence Among PLWH Who Have Achieved Viral Suppression","Addressing Barriers to Anti-hypertensive Medication Adherence Among Persons Living With HIV Who Have Achieved Viral Suppression","Inclusion Criteria:\n\nAims 1A and 1B\n\n* Age ≥18 years\n* Confirmed HIV+ diagnosis\n* Undetectable HIV viral load: defined as the most recent HIV viral load \\\u003C200 copies\u002FmL checked within the past year (assessed via chart abstraction)\n* Hypertension diagnosis in medical records\n* Taking an antihypertensive medication\n* Receiving care at the Duke HIV clinic\n\nAim 2\n\n* HIV providers including infectious disease physicians, internists or advance practice practitioners who have a patient pool of PLWH under their care in the last 6 months.\n\nAim 3A\n\n* Stakeholders composed of willing participants recruited from the Duke ID clinic and may include, HIV providers, clinic directors, nurses, pharmacists, social workers, people living with HIV who have hypertension and take antihypertensive medications, and representatives of the community advisory boards, and any other key stakeholders.\n\nAim 3 B\n\n* Age ≥18 years\n* Confirmed HIV+ diagnosis\n* Receiving care at the Duke ID clinic\n* Achievement of HIV suppression defined as having HIV-1 RNA \\\u003C200 copies\u002Fml\n* Take antihypertensive medications\n* Uncontrolled BP over a 12 months period defined by participants with systolic BP\\>130mmHg on ≥ 2 occasions in the past 12 months as indicated in the individual patient's electronic medical records\n\nExclusion Criteria:\n\nAims 1A, 1B and 3B\n\n* Severely hearing or speech impaired, or other disability that would limit participation in the intervention components\n* In a nursing home and\u002For receiving in-patient psychiatric care\n* Terminal illness with life expectancy \\\u003C 4 months\n* No reliable access to a telephone\n* Pregnant, breast-feeding, or planning a pregnancy during the study period\n* Planning to move out of the area in the next 6 months\n* Non-English speaking.",{"count":509,"type":23},60,[26],"Among those with hypertension, persons living with HIV (PWH) have a 50% higher risk of incident myocardial infarction compared to the general population, and they often fail to meet evidence-based treatment goals for hypertension. An important contributing factor for insufficient blood pressure control is non-adherence to antihypertensive medications. Research on medication adherence for PWH has largely focused on antiretroviral therapy adherence with limited focus on adherence to other non-AIDS condition medications.\n\nWith a large proportion of PWH in the U.S. achieving viral suppression, providers may now have an opportunity to focus on the management of non-AIDS conditions like hypertension. However, because PWH who have achieved suppression have reduced clinic encounters (once or twice a year) there is potential loss of opportunity to effectively monitor and intensify hypertension treatment as needed an important opportunity to focus on preventing cardiovascular disease. CVD and other non-AIDS comorbidities.\n\nThe study's overarching goal is to improve the hypertension outcomes for PWH on suppressive ART to reduce cardiovascular disease risk. In this study, we will identify and evaluate healthcare and patient-level factors that must be addressed in an intervention to increase hypertension medication adherence for PWH who have achieved viral suppression. We will use these factors to tailor an intervention and assess the feasibility and acceptability at the Duke ID clinic.",[513,92],"Hypertension",{"date":515,"type":49},"2026-03-30",{"date":517,"type":23},"2026-04-20",{"date":519,"type":23},"2026-09-30",{"name":521,"class":56},"Duke University",{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":24,"phases":531,"briefSummary":532,"conditions":533,"keywords":536,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":315},"100449762","treatment-research-investigating-depression-effects-on-neuroimmune-targets-trident-100449762","NCT05136703","Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)","TRIDENT","Inclusion Criteria:\n\n1. Age 18 or older\n2. Speaks and reads English\n3. Verified HIV+ status with antiretroviral medications bearing his\u002Fher name\n4. Current diagnosis on Major Depressive Disorder (MDD) using a structured clinical interview (DIAMOND) or Hamilton Rating Scale for Depression scores of 7 or greater\n5. If prescribed antidepressants, on a stable regimen and dose for at least 2 months\n6. Suppressed HIV viral load (\\\u003C 200 copies\u002FmL)\n7. Able to complete Functional Magnetic Resonance Imaging (fMRI) scans (i.e., no claustrophobia, no metal implants, no pacemaker, and BMI \\\u003C 40)\n\nExclusion Criteria:\n\n1. Unable to provide informed consent\n2. Active, untreated major mental illness\n3. Pregnancy at baseline\n4. Received CBT for depression in the past 2 years\n5. 5\\. Otherwise eligible but does not complete the run-in period that includes the baseline assessment, biospecimen collection, the fMRI visit, and a separately scheduled randomization visit",{"count":530,"type":23},150,[26],"The purpose of this randomized controlled trial is to understand how a cognitive-behavioral treatment (a form of psychological treatment) for depression changes the gut microbiome (micro-organisms that regulate the health of the gut), immune system, and the brain functioning in people living with HIV.",[534,92,535],"Depression","Inflammation",[534,537,35,538,539,540],"Microbiome","CBT-AD","Gut","Brain","2026-02-04",{"date":543,"type":49},"2026-02-06",{"date":545,"type":49},"2022-08-30",{"date":547,"type":23},"2027-12-31",{"name":549,"class":56},"Florida International University",{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":24,"phases":559,"briefSummary":560,"conditions":561,"keywords":563,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":57},"100565934","acceptance-and-commitment-therapy-for-hiv-hazardous-drinkers-100565934","NCT06648629","Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers","Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Living with HIV\n* Drink at unhealthy levels based on self-reported answers to the AUDIT-C, referencing drinking over the previous 3 months \\[score of ≥4 (men) or ≥3 (women) will be used to identify eligible participants\\]\n* on HIV treatment and are\n* 18 years or older.\n* Read at an 8th grade level\n* Can provide a physical address\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Anyone with a score = 12 on the AUDIT-C will be excluded.\n* Anyone with a score ≥20 on the PHQ-9, indicative of severe depression, will be excluded.\n* Anyone with a score of ≥15 on the GAD-7, indicative of severe anxiety, will be excluded.\n\nReferrals for mental health treatment will be given to all participants who screen out.",{"count":558,"type":23},300,[26],"Alcohol consumption is a critical factor in HIV treatment that significantly contributes to poor treatment-related outcomes. Randomized clinical trials (RCTs) of alcohol interventions for people with HIV (PWH) have had limited success, perhaps due to an increasingly recognized co-morbitity of co-occurring hazardous alcohol use and other mental health-related problems among PWH. This has necessitated a shift in the literature towards trans-diagnostic approaches that target core psychological processes that underlie multiple mental health-related problems. One trans-diagnostic mechanism that is relevant to alcohol and other substance use is experiential avoidance (EA)- i.e., repeated, and maladaptive, use of substances and\u002For other behaviors to escape or avoid unwanted thoughts, feelings, and\u002For urges. Acceptance and commitment therapy (ACT) targets EA and is an empirically supported treatment for multiple psychological and behavioral health-related outcomes; however there have not been any full-scale RCTs of ACT for alcohol use among any population, including PWH. The investigators recently adapted a telephone-delivered ACT intervention originally developed for smoking cessation, into an intervention for PWH who drink at unhealthy levels (NIH\u002FNIAAA; R34AA026246). This six-session, telephone-delivered ACT intervention for alcohol use showed high feasibility and acceptability in a pilot RCT conducted by our team. The overall objective of this application is therefore to determine if ACT can significantly reduce alcohol use and comorbid symptoms of depression, anxiety, and stress among adult PWH who drink at unhealthy levels. The specific aims are: To determine the relative efficacy of ACT, compared to BI, for reducing alcohol use among PWH (Aim 1) and to determine if ACT has an effect on trans-diagnostic processes that in turn affect alcohol use and other psychological and functional outcomes (Aim 2). The investigators will accomplish these aims by: conducting a remote, RCT in which the investigators randomly assign 300 PWH who drink at unhealthy levels to either the ACT intervention the investigators developed (n = 150), or a BI intervention (n = 150) previously shown to reduce alcohol use among PWH. The investigators will assess alcohol-related outcomes-via self-report and a biomarker- at baseline, post-treatment (7 weeks post-baseline), and again 3-, 6-, and 12-months post-randomization. The investigators will also measure EA to determine if it mediates treatment effects for alcohol use and other psychological and functional outcomes, measured at all timepoints.",[92,562],"Alcohol Drinking",[35,564,565,566],"Alcohol","ACT","Treatment","2026-02-02",{"date":541,"type":49},{"date":570,"type":49},"2025-01-22",{"date":572,"type":23},"2028-08",{"name":574,"class":56},"Syracuse University",{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":582,"targetDuration":4,"studyType":24,"phases":584,"briefSummary":586,"conditions":587,"keywords":590,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":603,"locationsCount":4},"100470851","phase-3-paclitaxel-and-pegylated-liposomal-doxorubicin-for-treatment-of-hiv-related-kaposi-sarcoma-100470851","NCT05411237","Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma","A Phase III, Randomized, Open-Label, Non-Inferiority Study of Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma in Resource-Limited Settings","Inclusion Criteria:\n\n1. HIV-1 infection.\n2. Histologically confirmed KS at any time prior to study entry, confirmed by an AIDS Malignancy Consortium (AMC)-certified pathologist.\n3. Current stage T1 KS (irrespective of prior treatment with antiretroviral therapy (ART) OR\n\n   Stage T0 KS that has progressed or not responded after a minimum of 12 weeks of treatment with ART. Participants with T0 KS must have either:\n   * 20 or more skin and\u002For oral KS lesions, and\u002For\n   * any number of lesions on exposed body areas that have an adverse effect on quality of life (e.g., stigmatization).\n4. Men and women ≥ 18 years. Because no dosing or adverse event data are currently available on the use of PTX or PLD for AIDS-KS in persons \\\u003C18 years of age, children are excluded from this study\n5. Karnofsky performance status ≥ 60 (ECOG ≤ 2).\n6. Echocardiogram or Multiple gated acquisition scanning (MUGA) showing an ejection fraction ≥ 50%.\n7. Ability and willingness of participant or legal guardian to provide informed consent.\n8. Participants may be ART-naïve or ART-experienced but must be able to receive an ART regimen considered likely to result in HIV suppression.\n9. Measurable cutaneous KS, defined as follows:\n\n   * When available, a minimum of five bi-dimensionally measurable KS cutaneous marker lesions.\n   * If fewer than five bi-dimensionally measurable marker lesions are available, the total surface area of the marker lesion(s) must be ≥ 700mm2.\n10. The following laboratory values obtained within 14 days prior to study entry:\n\n    * Absolute Neutrophil Count ≥ 1000 cells\u002Fmm3.\n    * Hemoglobin ≥ 8 g\u002FdL (may be achieved with transfusion if clinically indicated, in the opinion of the investigator).\n    * Platelet count ≥ 75,000\u002Fmm3.\n    * ALT, AST, Alkaline phosphatase \\\u003C 5 × upper limit of normal (ULN).\n    * Total bilirubin: ≤ 1.5 × ULN, unless the participant is receiving an antiretroviral drug known to be associated with increased bilirubin, in which case the direct fraction should be ≤ 2 x the ULN.\n    * Creatinine \\\u003C institutional ULN OR estimated glomerular filtration rate (GFR) ≥ 30 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal.\n11. Women of reproductive potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months), must have a negative pregnancy test done within 24 hours of initiating the protocol-specified chemotherapy medication.\n12. Participants must agree to use two reliable forms of contraception simultaneously while receiving study protocol-specified medication and for 6 months after stopping the medication.\n13. Adequate venous access.\n14. No prior chemotherapy or use of systemic cytotoxic therapy agents.\n15. Participant is able to understand and willing to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Current acute, chronic, or recurrent infections that are serious, in the opinion of the site investigator, for which the participant has not completed at least 14 days of therapy before study entry and\u002For is not clinically stable.\n2. Serious illness necessitating hospitalization\u002Fsystemic treatment within 14 days prior to study entry\n3. Breastfeeding or pregnant women are excluded because of potential risks of cytotoxic chemotherapy to an unborn child or infant.\n4. Known history of congestive heart failure and\u002For systolic ejection fraction \\\u003C 50%.\n5. Prior radiotherapy to KS indicator lesions\n6. Prior or current immunotherapy\n7. Any immunomodulator, HIV vaccine, live attenuated vaccine, other investigational vaccine within 30 days prior to study entry, excluding vaccines against COVID-19\u002FSARS-CoV-2, which are permitted.\n8. Known allergy\u002Fhypersensitivity to the study drug or its formulation\n9. Any condition, including the presence of laboratory abnormalities, which in the opinion of the responsible investigator places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study.\n10. Corticosteroid use at doses above those given for replacement therapy for adrenal insufficiency within the last 30 days prior to study entry.\n11. Patients with psychiatric illness and\u002For social circumstances that would limit compliance with study requirements.",{"count":583,"type":23},130,[585],"PHASE3","This study is being done to determine if two different anti-cancer drugs, paclitaxel (PTX) and pegylated liposomal doxorubicin (PLD) have similar effects on treating Kaposi Sarcoma (KS) in people living with HIV (human immunodeficiency virus) in sub-Saharan Africa. Patients with HIV-related KS will receive either PTX or PLD once every 3 weeks for a total of six cycles.",[588,92,589],"Kaposi Sarcoma","AIDS-related Kaposi Sarcoma",[591,592,593,594,595],"Paclitaxel","Pegylated liposomal doxorubicin","AIDS associated Kaposi Sarcoma","Human Immunodeficiency Virus","HIV-related Kaposi Sarcoma","2026-01-22",{"date":598,"type":49},"2026-01-23",{"date":600,"type":23},"2026-09",{"date":602,"type":23},"2030-09",{"name":604,"class":499},"AIDS Malignancy Consortium",{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":611,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":613,"enrollmentInfo":614,"targetDuration":4,"studyType":24,"phases":615,"briefSummary":616,"conditions":617,"keywords":618,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":625,"completionDateStruct":626,"leadSponsor":628,"locationsCount":315},"100620435","phase-4-efficacy-and-safety-of-doravirine-in-the-rapid-initiation-100620435","NCT07357584","Efficacy and Safety of Doravirine in the Rapid Initiation","Efficacy and Safety of Doravirine in the Rapid Initiation of Highly Active Antiretroviral Therapy (HAART) in HIV-1positive Patients Without Prior Treatment","RapiDO","Inclusion Criteria:\n\n1. Subject has to voluntarily signed and dated an informed consent form, approved by an institutional ethics committee.\n2. ≥18 years of age.\n3. Not previously exposed to ARV (naïve). Subject may have received oral PrEP and PEP within the last 6 months and injectable PrEP and PEP within the last year.\n4. Have a received an HIV diagnosis within 30 days prior to selection. Defined as: Having confirmed HIV-1 infection. HIV-1 positive result is considered if the HIV1 RNA in plasma is ≥ 1000 copies\u002FmL or two HIV antibody tests (using two different tests) are positive.\n\n   NOTE: Participants may be included without knowing their baseline viral load. If baseline viral load results are less than 1000 copies\u002FmL, the volunteer's participation will be suspended and they will be considered to have failed the screening test. A viral load brought by the subject may be considered if it was performed within the last 30 days prior to the SCR visit.\n5. CD4+ T-cell count: No limit.\n6. Subjects able to meet the protocol requirements.\n\nExclusion Criteria:\n\n1. History of hypersensitivity to doravirine, tenofovir, or lamivudine.\n2. Severe hepatic impairment (Child-Pugh C).\n3. Active HCV infection requiring specific treatment during study participation at the time of eligibility assessment. If HCV is diagnosed during the study and the participant requires treatment, the decision on whether to continue in the study will be at the investigator's discretion.\n4. A woman may be eligible to enter and participate in the study if she is not pregnant (confirmed by a negative urine pregnancy test at the time of screening\u002Fbaseline). If the baseline visit is scheduled on a different day than the SCR, the urine pregnancy test will be repeated) or breastfeeding and if at least one of the following conditions applies:\n\n   1. Women without reproductive capacity, defined as premenopausal women with tubal ligation or hysterectomy, or documented bilateral oophorectomy; or as postmenopausal women with 12 months of spontaneous amenorrhea, and women ≥ 45 years of age without hormone replacement therapy.\n   2. Women with reproductive capacity who agree to adopt one of the contraceptive options in Appendix 2 for at least 30 days after the last dose of study medication and\u002For completion of the follow-up visit.\n\n   The chosen contraceptive method must be used consistently, according to the approved product label. All study participants must be advised on safer sex practices, including the use of effective barrier methods, and the choice of effective contraceptive method must be documented in the eCRF (Electronic Case Report Form).\n5. The subject's general health status, in the investigator's oIPnion, interferes with the requirements of the study.\n6. Has a diagnosis of an active opportunistic infection defining AIDS or a malignant neoplasm within 30 days prior to evaluation (except Kaposi's sarcoma with fewer than 10 skin lesions).\n7. Is participating or has participated in a clinical study in the last 6 months.\n8. Creatinine clearance (CrCl) ≤50 mL\u002Fmin according to the Cockcroft-Gault equation.\n9. Any verified Grade 4 abnormality (except liIPds: HDL, LDL, total cholesterol, triglycerides).\n10. History or presence of allergy to study drugs or their components, or to drugs in their class.\n11. Subjects taking any medication during the study, including over-the-counter medications and herbal preparations, without the approval of the study physician.\n12. Mutations resistant to doravirine, 3TC, or TDF, according to the list described below:\n\nDOR mutations (INNTI):\n\nDoravirine (INNTI) Primary: the presence of one or more ART-resistant mutations will be grounds for exclusion.\n\nMutations: V106A\u002FM, F227C\u002FV, L234I, Y188L, Y318F, M230I\u002FL. Secondary: the presence of one or more RAMs will be grounds for exclusion. Mutations: A98G, V108I, G190E, H221Y, P225H, F227L, P236L. Others: the presence of five or more RAMs will be grounds for exclusion. Mutations: V90I, L100I, K101E\u002FH\u002FP, K103N\u002FR\u002FS, V106I, I135T, Y181C\u002FI\u002FV, E138A\u002FG\u002FK\u002FQ\u002FR, V170F\u002FT, G190A\u002FQ\u002FS, Y188C\u002FH, F227I, V245E, K311R.\n\nNRTI (TDF) Relevant mutations: Presence of one or more RAM Mutations: K65R, insertion 69, K70R\u002FE, Q151M,\n\nNRTI (3TC) Relevant mutation Presence of IM184V","90 Years",{"count":299,"type":23},[177],"Protocol title: \"Efficacy and safety of doravirine in the rapid initiation of highly active antiretroviral therapy (HAART) in HIV-1positive patients without prior treatment.\"",[92],[619,620,621,622],"Efficacy","Safety","Doravirine","Rapid initiation of highly active antiretroviral therapy","2026-01-20",{"date":596,"type":49},{"date":48,"type":23},{"date":627,"type":23},"2028-01-13",{"name":265,"class":56},{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":635,"eligibilityCriteria":636,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":637,"targetDuration":4,"studyType":24,"phases":639,"briefSummary":640,"conditions":641,"keywords":642,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":655},"100531694","phase-3-doravirine-versus-dolutegravir-based-antiretroviral-regimens-in-treatment-nave-people-living-with-hiv-1-infection-100531694","NCT06203132","DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection","Phase III, Open-label, Randomized, Multicenter Trial EvaLuating the Non-inferiority of DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection","ELDORADO","Inclusion Criteria:\n\n* Be at least 18 years of age on the day of signing the informed consent.\n* Be HIV-1 positive as determined according to national testing strategies\n* Have a plasma HIV-1 RNA ≥1000 copies\u002FmL within 30 days prior to the randomization,\n* Have HIV treatment indication based on physician assessment according to local treatment guidelines\n* Be naïve to antiretroviral therapy (ART) including investigational antiretroviral agents\n* For women or transgender men of childbearing potential i.e. of childbearing age who are not menopausal, or permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy) or not refraining from sexual activity: negative urinary test for pregnancy and acceptance to use contraceptive methods\n* Understand the study procedures and voluntarily agree to participate by giving written informed consent for the trial.\n\nNon-inclusion Criteria:\n\n* Has ongoing (pulmonary or extra-pulmonary) tuberculosis\n* Has any other history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.\n* Is infected with HIV-2 or co-infected with HIV-1 and HIV-2\n* Has received cabotegravir long acting or dapivirine pre-exposure prophylaxis (PrEP).\n* Has received oral pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) in the past three months or has had no negative HIV-1 serology performed\n* Has documented or known resistance or possible resistance to study drugs (in France and where national guidelines recommend screening for primary resistance before starting first-line ART) as defined by the ANRS MIE AC43 Resistance group\n* Has the following laboratory values at screening visit, within 30 days prior to the randomization:\n\n  * AST (SGOT) and ALT (SGPT) \\>4.0 x upper limit of normal\n  * Estimated glomerular filtration rate at time of screening \\\u003C60 mL\u002Fmin\u002F1.73m², based on the CKD-EPI equation\n* Has participated in a study with an investigational compound\u002Fdevice within 30 days prior to signing informed consent or anticipates participating in such a study involving an investigational compound\u002Fdevice during the course of this study.\n* Has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study\n* Requires or is anticipated to require any of the prohibited or contraindicated medications noted in the trial protocol.\n* Has significant hypersensitivity or other contraindication to any of the components of the study drugs.\n* Is pregnant, breastfeeding, or expecting to conceive at any time during the study.\n* Has any condition which might, in the investigator's opinion, compromise the safety of treatment and\u002For patient's adherence to study procedure.\n* Is a person under guardianship or deprived of freedom by a judicial or administrative decision",{"count":638,"type":23},610,[585],"Phase III trial evaluating doravirine as an alternative to dolutegravir in treatment naïve people living with HIV-1 infection.",[92],[120,643,644,645,646],"ART-naïve","doravirine","dolutegravir","non-inferiority","2026-01-06",{"date":649,"type":49},"2026-01-07",{"date":651,"type":49},"2025-01-27",{"date":653,"type":23},"2027-11",{"name":134,"class":135},19,{"id":657,"slug":658,"hasResults":12,"nctId":659,"briefTitle":660,"officialTitle":661,"acronym":4,"eligibilityCriteria":662,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":663,"targetDuration":4,"studyType":24,"phases":665,"briefSummary":666,"conditions":667,"keywords":668,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":671,"lastUpdatePostDateStruct":672,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":677,"locationsCount":57},"100616682","phase-2-a-phase-a-clinical-study-of-cl-197-capsules-100616682","NCT07308782","A Phase Ⅱa Clinical Study of CL-197 Capsules","An Exploratory Pharmacodynamic Clinical Study of CL-197 Capsules in Treatment Naive Patients With Human Immunodeficiency Virus (HIV-1)","Inclusion Criteria:\n\n1. Participants aged 18-60 (including boundary values), both male and female.\n2. Body mass index (BMI) range between 18.5-29.9 (including the boundary value). Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women.\n3. Participants diagnosed with HIV-1 infection before screening, and never received any anti-HIV drugs or HIV-related vaccine therapy (including investigational or other unmarketed anti-HIV drugs or vaccines) before screening.\n4. Participants who agree not to receive other anti-HIV drugs during the trial period (from signing the informed consent form until the Day 13 sampling).\n5. CD4 cell count \\> 200 cells\u002FμL at screening.\n6. Women of childbearing potential (WOCBP) must have adopted effective non-drug contraceptive measures, have a negative serum pregnancy test at screening\u002Fbaseline, and be willing to use appropriate effective methods of contraception from signing the informed consent form until 3 months after the last dose of the study drug. Male study participants must be willing to refrain from fathering children and voluntarily use effective contraception during the trial and until 3 months after the last dose of the study drug, or have been surgically sterilized.\n7. Participants who understand and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Diagnosis of acute HIV-1 infection, or presence of an AIDS-defining disease at enrollment, or history of an opportunistic infection within 3 months prior to enrollment with the condition remaining unstable within 4 weeks prior to enrollment.\n2. Had pre-exposure prophylaxis (PrEP) and\u002For post-exposure prophylaxis (PEP) treatment within 1 month prior to screening.\n3. Had any clinically significant disease (including cardiovascular, respiratory, digestive, endocrine\u002Fmetabolic, neurological\u002Fpsychiatric, hematological, and immune system diseases, etc.) that is poorly controlled, as determined by the investigator at screening.\n4. Resting systolic blood pressure ≥ 140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg, or heart rate \\> 100 beats per minute, or heart rate \\\u003C 50 beats per minute, or QTcF (QT interval corrected for heart rate according to Fridericia's formula) \\> 450 ms, or fasting blood glucose ≥ 7.0 mmol\u002FL.\n5. History of severe allergy (immediate, life-threatening systemic anaphylaxis) to drugs (e.g., aspirin or cephalosporin antibiotics), other drug components (e.g., lactose or gelatin), or food, or history of allergic diseases requiring medication control (e.g., asthma, urticaria, atopic dermatitis\u002Feczema, etc.) prior to screening.\n6. Had major gastrointestinal surgery within 6 months prior to screening (except uncomplicated appendectomy or cholecystectomy), or any surgery that could affect drug absorption, distribution, metabolism and excretion; or planned elective surgery during the trial period, as determined by the investigator at screening.\n7. History of malignancy (except carcinoma in situ of the cervix treated with conization, or radically resected basal cell carcinoma, squamous cell carcinoma, and\u002For carcinoma in situ \\[Bowen's disease\\] of the skin).\n8. Hepatitis B surface antigen (HBsAg) positive at screening, or active syphilis, or Hepatitis C virus (HCV) antibody positive, or previous interferon treatment for HBV infection leading to HBsAg seroconversion.\n9. Hemoglobin (Hb) \\\u003C 110 g\u002FL, or white blood cell (WBC) count \\\u003C 3 × 10\\^9\u002FL, or absolute neutrophil count (ANC) \\\u003C 1 × 10\\^9\u002FL, or platelet (PLT) count \\\u003C 100 × 10\\^9\u002FL at screening.\n10. Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) ≥ 2.5 times upper limit of normal (ULN), or total bilirubin (TBIL) ≥ 1.5 × ULN at screening.\n11. Serum creatinine (SCr) \\> 1.1 × ULN, or creatinine clearance (Ccr) \\\u003C 60 mL\u002Fmin (calculated by Cockcroft-Gault formula) at screening.\n12. Participants smoke more than 5 cigarettes daily on average within 3 months prior to screening, or may be unwilling to stop using any tobacco products during drug administration and sampling periods.\n13. Drinking more than 14 units of alcohol (1 unit of alcohol ≈ 360 mL of beer with 5% alcohol, or 45 mL of liquor with 40% alcohol, or 150 mL of wine with 12% alcohol) within 3 months prior to screening on average, or positive alcohol breath test at screening or baseline, or unwillingness to stop using any alcohol-containing products during hospitalization.\n14. Excessive consumption of tea, coffee, and\u002For caffeine-containing beverages (averaging more than 8 cups per day, 1 cup ≈ 250 mL) within 3 months prior to screening on average, or unwillingness to stop consuming tea, coffee, and\u002For caffeine-containing beverages during hospitalization.\n15. Participants with consumption of pitaya, mango, pomelo, carambola, or foods\u002Fbeverages prepared from them, or foods\u002Fbeverages containing xanthine, caffeine, or alcohol (including chocolate, tea, coffee, cola, cocoa, etc.), or any other special diet that may affect drug absorption, distribution, metabolism, or excretion within 48 hours prior to the first dose of the investigational product, or unwillingness to stop using them during hospitalization.\n16. History of drug abuse (non-medical, excessive, misuse, or addictive use of any drug leading to social, psychological, or physical impairment) within 5 years prior to screening, or positive urine drug screen at screening or baseline.\n17. Intolerance to venipuncture, or history of needle or blood phobia, or blood donation (including component blood) or significant blood loss (≥400 mL) or blood transfusion within 3 months prior to screening, or blood donation plan during the trial.\n18. Specific dietary requirements during the trial, or inability to accept the standardized diet.\n19. Have participated in or are participating in other investigational drug or interventional medical device clinical trials (having signed informed consent and received investigational drug\u002Finterventional device or placebo) within 3 months prior to screening.\n20. Pregnant or breastfeeding females at screening, or positive serum pregnancy test (applicable to WOCBP only).\n21. Have a birth plan (including egg or sperm donation) by WOCBP or male participants from 1 month prior to informed consent until 3 months after administration of the investigational drug, or unwillingness to use effective contraception\u002Fbarrier methods (including one or more non-drug contraceptive methods or abstinence from heterosexual activity).\n22. Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health products within 14 days prior to dosing.\n23. Any other conditions considered by the investigator as unsuitable for participation in this trial.",{"count":664,"type":23},24,[201],"This study will evaluate the antiretroviral activity, safety and pharmacokinetics of single dose of CL-197 capsule in three dose groups administered to antiretroviral treatment-naïve adult participants with human immunodeficiency virus type 1 (HIV-1) infection.",[29],[669,670],"HIV-1 infection","CL-197","2026-01-05",{"date":647,"type":49},{"date":674,"type":49},"2025-11-29",{"date":676,"type":23},"2027-03",{"name":678,"class":189},"Henan Genuine Biotech Co., Ltd."]