[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Advancing Clinical Therapeutics Globally for HIV\u002FAIDS and Other Infections\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":110},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,68,90],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100581889","phase-4-menopausal-ht-for-women-living-with-hiv-hot-100581889",false,"NCT06856174","Menopausal HT for Women Living With HIV (HoT)","Menopausal Hormone Therapy for Women Living With HIV (HoT)","HoT","* Living with HIV\n* Assigned female sex at birth\n* Between the ages of 40 and 60 years\n* In the late menopausal transition (perimenopause) or early postmenopause\n* Experiencing hot flashes and\u002For night sweats\n* Willing and able to complete a daily diary\n* Does not have medical condition that would contraindicate hormone therapy\n* Not taking medications to treat hot flashes\n* Not taking medications that cannot be combined with hormone therapy\n* Receiving antiretrovirals (HIV medication) for more than 1 year\n* Not pregnant and willing and able to use at least non-hormonal birth control to prevent pregnancy\n* Willing and able to provide informed consent after discussion with the research staff","FEMALE","40 Years","60 Years",{"count":21,"type":22},105,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","Women living with HIV have been shown to experience more frequent and severe hot flashes and night sweats (collectively known as vasomotor symptoms) as compared to women living without HIV. This correlates with disturbed sleep, increased depressive symptoms, increased anxiety, worse mental function, interference with activities of daily living including work, and worse overall quality of life.\n\nHormone therapy is considered to be the most effective therapy for hot flashes and night sweats and the most appropriate choice to prevent bone loss at the time of menopause for women without HIV. However, the usefulness of hormone therapy has not been specifically studied in women living with HIV.\n\nThis trial is being done to see if:\n\n* There is evidence to support the use of hormone therapy (estradiol with or without progesterone) for the treatment of hot flashes and night sweats in women living with HIV\n* Hormone therapy improves mental function, mood, sleep, quality of life, bone health, heart health, and inflammation in women living with HIV\n* Hormone therapy is safe and tolerable for women living with HIV",[28,29],"HIV Infection","Menopause","RECRUITING","2026-05-20",{"date":33,"type":34},"2026-05-22","ACTUAL",{"date":36,"type":34},"2026-04-09",{"date":38,"type":22},"2027-09-20",{"name":40,"class":41},"Advancing Clinical Therapeutics Globally for HIV\u002FAIDS and Other Infections","NETWORK",23,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100531883","phase-2-therapeutic-id93--gla-se-vaccination-in-participants-with-rifampicin-susceptible-pulmonary-tb-100531883","NCT06205589","Therapeutic ID93 + GLA-SE Vaccination in Participants With Rifampicin-Susceptible Pulmonary TB","A Phase 2a\u002F2b Study Evaluating Safety, Immunogenicity, and Therapeutic Efficacy of ID93 + GLA-SE Vaccination in Participants With Rifampicin-Susceptible Pulmonary TB","Inclusion Criteria Groups 1-5:\n\n* Bacteriologically confirmed rifampicin-susceptible pulmonary TB using phenotypic drug susceptibility testing or a World Health Organization (WHO) approved molecular test.\n* Documentation of HIV status as positive or negative by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E\u002FCIA) test kit.\n* For individuals with HIV, on locally approved HIV ART for at least 90 days prior to entry.\n* For individuals with HIV, CD4+ cell count ≥250 cells\u002Fmm3 obtained within 90 days prior to entry at any network-approved non-US laboratory that is DAIDS IQA certified.\n* For individuals with HIV, HIV-1 RNA below the limit of detection obtained within 90 days prior to entry by any network-approved laboratory outside the US that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs.\n* Laboratory values within the indicated ranges, obtained within 14 days prior to entry by any network-approved laboratory outside the US that operates in accordance with GCLP and participates in appropriate external quality assurance programs.\n\n  * Absolute neutrophil count (ANC) ≥800 cells\u002Fmm3\n  * Hemoglobin ≥8.5 g\u002FdL for candidates assigned female sex at birth and \\>9.0 g\u002FdL for candidates assigned male sex at birth\n  * Platelet count ≥100,000\u002Fmm3\n  * Serum creatinine ≤1.5 X upper limit of normal (ULN)\n  * AST (SGOT), ALT (SGPT), and alkaline phosphatase, ≤2.5 X ULN\n  * Total bilirubin ≤2 X ULN\n* For candidates who are able to become pregnant, negative serum or urine pregnancy test at or within 7 days prior to entry by any network-approved laboratory or clinic outside the US that operates in accordance with GCLP and participates in appropriate external quality assurance programs.\n* Candidates who are able to become pregnant must agree to use an adequate method of contraception (barrier methods or non-hormonal intrauterine device) or abstain from sexual activity that could lead to pregnancy from at least 21 days prior to the first scheduled vaccination through 90 days after last dose.\n* Candidates assigned female sex at birth (AFAB) must agree to not seek pregnancy through alternative methods, such as oocyte retrieval, artificial insemination, or in vitro fertilization, from at least 21 days prior to the first scheduled vaccination through 90 days after last dose.\n* For candidates who are not of child-bearing potential, acceptable documentation (written documentation or oral communication from a clinician or clinician's staff documented in source documents: physician report\u002Fletter, operative report or other source documentation in the candidate record, discharge summary, laboratory report, etc.) of hysterectomy and bilateral oophorectomy, tubal ligation, tubal micro-inserts, vasectomy, or menopause.\n* Ability and willingness of candidate to provide informed consent.\n\nInclusion Criteria Groups 1 and 2 \\[Step 2\\]:\n\n* Documented duration of local SOC TB treatment prior to entry into Step 2 (study entry) for i. Group 1 of between 113 and 127 days (i.e., approximately 4 months of TB treatment) ii. Group 2 of between 83 and 97 days (i.e., approximately 3 months of TB treatment)\n\nInclusion Criteria, Groups 3, 4, and 5 \\[Step 1\\]:\n\n* Initiation of local SOC TB treatment within 7 days prior to entry into Step 1 (Study entry).\n\nExclusion Criteria Groups 1-5:\n\n* Documented M.tb resistance to isoniazid.\n* Breastfeeding.\n* Any previous episode of TB treatment.\n* TB treatment with a local non-standard first-line TB treatment regimen at time of enrollment.\n* Receipt of any investigational drug or any investigational non-TB vaccine since start of TB treatment.\n* Any prior receipt of any investigational TB vaccine.\n* Known allergy or any hypersensitivity to any components of study product or their formulation or any vaccination.\n* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n* History of moderate to serious autoimmune disease requiring immunosuppressive therapy.\n* Receipt of immunosuppressive medications (except as noted below) from start of TB treatment.\n\n  * Corticosteroid nasal spray\n  * Inhaled corticosteroids\n  * Topical corticosteroids for mild, uncomplicated dermatologic condition\n  * A single course of oral\u002Fparenteral prednisone or equivalent at doses \\\u003C60 mg\u002Fday and for \\\u003C11 days with completion at least 30 days prior to entry.\n* Receipt of Emergency Use Authorization (EUA)\u002FEmergency Use Listing (EUL) or licensed live attenuated vaccines (e.g., measles, mumps, and rubella \\[MMR\\], oral polio vaccine \\[OPV\\], varicella, yellow fever, live attenuated influenza vaccine, live attenuated COVID-19 vaccine) within 30 days prior to entry.\n* Receipt of any EUA\u002FEUL or licensed vaccines that are not live attenuated vaccines (e.g., tetanus, pneumococcal, Hepatitis A or B, not live attenuated COVID-19 vaccine) within 14 days prior to entry.\n* Receipt of immunoglobulin or blood-derived products within 90 days prior to entry.\n* History of angioedema, or anaphylaxis, except as noted.\n* History of generalized urticaria within past 5 years.\n* Malignancy, except as noted.\n* Daily (current) use of a short-acting rescue inhaler (e.g., a beta 2 agonist).\n* Within the previous year, exacerbation of asthma symptoms requiring emergency care, urgent care, hospitalization, or intubation.\n* Uncontrolled diabetes mellitus type 1 or type 2, defined as Hemoglobin A1c (HbA1C) \\>7%.\n* Bleeding disorder (e.g., factor deficiency, coagulopathy, platelet disorder requiring special precautions).\n* Seizure disorder, including either of the following within the previous 3 years:\n\n  * Seizure(s)\n  * Use of medications to prevent or treat seizure(s)\n* Acute or serious illness, including COVID-19, requiring systemic treatment and\u002For hospitalization from start of TB treatment, other than for pulmonary TB.\n* Documentation of clinically significant (as judged by the site investigator) active infections (including HIV-related opportunistic infections) other than TB and HIV requiring treatment within 30 days prior to entry.\n* Evidence of clinically significant disease (as judged by the site investigator) or any other abnormalities (other than the indication being studied) that would interfere with study product, procedures, or interpretation of study outcome data, or otherwise interfere with achieving the study objectives.\n* Suspected or documented TB involving the central nervous system, renal TB or TB pericarditis, or current extrapulmonary TB involving other organ systems that might interfere with study product or procedures, as judged by the site investigator.\n* Contraindication to intramuscular injection in both deltoids.","ALL","18 Years","65 Years",{"count":54,"type":22},1500,[56],"PHASE2","This study is being done to test an experimental study vaccine compared to a placebo. The experimental study vaccine is called ID93 + GLA-SE. ID93 + GLA-SE has been used in humans in research but has not been approved for use in medical care. This study will be the first to test ID93 + GLA-SE in people living with HIV (PLWH). The injections during the study will be given to different groups of participants while they are using standard TB treatment. One of the research questions is to understand the differences in immune system responses depending on the timing of giving the injections after people begin taking standard TB treatment. Researchers also want to continue to look at whether the study vaccine is safe when tested in a larger group of people, and if getting the study vaccine in addition to standard TB treatment can help to lower the number of poor TB outcomes that people might have.",[59],"Tuberculosis, Pulmonary","NOT_YET_RECRUITING","2026-04-06",{"date":36,"type":34},{"date":64,"type":22},"2026-07-01",{"date":66,"type":22},"2029-10-13",{"name":40,"class":41},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":19,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":5},"100531884","phase-2-antiretrovirals-combined-with-antibodies-for-hiv-1-cure-in-africa-100531884","NCT06205602","Antiretrovirals Combined With Antibodies for HIV-1 Cure In Africa","A Randomized, Double-Blind, Placebo-Controlled Study of the Combination of Two Long-Acting Broadly Neutralizing Antibodies at ART Initiation in Adults Living With HIV-1 in Sub-Saharan Africa: The ACACIA Study","ACACIA","Step 1 Inclusion Criteria:\n\n* Confirmed HIV-1, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E\u002FCIA) test kit at any time prior to study Step 1 entry AND Confirmed by one of the following:\n\n  * A second antibody test from different manufacturers or based on different principles and epitopes (combination antigen-antibody-based rapid tests may be used)\n  * HIV-1 antigen\n  * Plasma HIV-1 RNA viral load or\n  * A licensed Western blot\n\nNOTE: The term \"licensed\" refers to a US FDA or DAIDS Clinical Laboratory Oversight (DCLOT) approved test.\n\nWHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E\u002FCIA that is based on a different antigen preparation and\u002For different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.\n\n* ART-naïve \\[NOTE: Prior use of PrEP or PEP is allowed, except use of long-acting ARVs (e.g., cabotegravir, rilpivirine) within the last 24 months.\\]\n* CD4+ T cell count \\>200 cells\u002Fmm3 obtained within 28 days prior to study entry at any Network-approved non-US laboratory that is (IQA) certified.\n* Plasma HIV-1 RNA \\>1000 copies\u002FmL obtained within 28 days prior to study entry performed at any Network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance (EQA) programs.\n* For study candidates of child-bearing potential, negative urine or serum pregnancy test within 72 hours prior to study entry by any Network-approved non-US laboratory or clinic that operates in accordance with GCLP and participates in appropriate EQA programs.\n\n\\[NOTE A: Persons who are of child-bearing potential are individuals who have not been post-menopausal for at least 24 consecutive months, who have had menses within the preceding 24 months, and who have not undergone surgical sterilization, specifically hysterectomy and\u002For bilateral oophorectomy, tubal ligation, or bilateral salpingectomy.\\] \\[NOTE B: Acceptable documentation of hysterectomy and bilateral oophorectomy, tubal ligation, and tubal micro-inserts are written documentation or oral communication from a clinician or clinician's staff documented in source documents (physician report\u002Fletter, operative report or other source documentation in the patient record, discharge summary, laboratory report, etc.). Participant-reported history is acceptable for documentation of menopause.\\]\n\n* Persons of child-bearing potential who are able to become pregnant must agree to use two methods of contraception, if participating in sexual activity that could lead to pregnancy. One contraceptive method must be from the list of highly effective methods listed below. The second method of contraception must be a barrier method or abstinence. Both methods of contraception must be used during Step 1. The two effective forms of birth control have to be used for 10 days before receiving the first study drug infusion, for at least 12 months after the product infusion, and until ART is reinitiated and viral suppression is achieved.\n\nAcceptable methods of contraception include:\n\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* Partner sterilization with documentation of azoospermia prior to the participant's entry into the study, and this individual is the sole partner for that participant.\n\n\\[NOTE: Documentation of partner sterility can come from the site personnel's review of participant's 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* Individuals engaging in sexual activity that could lead to their partner becoming pregnant must agree to use a barrier method of contraception to avoid pregnancy in a spouse or partner of reproductive potential. The barrier method must be used to prevent partner pregnancy during Step 1 and for at least 12 months after the product infusion.\n* Ability and willingness to use a barrier protection or abstinence from sexual intercourse during Step 1 until viral suppression is achieved, during the ATI period (Steps 2-3), and until plasma HIV-1 RNA is less than limit of detection after ART restart (Step 4) with partners without HIV or whose HIV serostatus is unknown in order to prevent HIV transmission to sexual partners.\n* Ability and willingness to initiate ART at enrollment.\n* Ability and willingness to participate in scheduled study visits, including ATI per the SOE.\n* Ability and willingness to provide informed consent.\n\nStep 2 Inclusion Criteria:\n\n* Documented negative hepatitis B virus (HBV) surface antigen (HBsAg) obtained within 16 weeks prior to Step 2 registration by any Network-approved non-US laboratory that operates in accordance with GCLP and participates in appropriate EQA programs.\n* Documented negative HCV antibody (anti-HCV), negative HCV RNA PCR, or negative HCV antigen obtained within 16 weeks prior to Step 2 registration by any Network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate EQA programs.\n* Participants diagnosed with a bacterial sexually transmitted infection (STI) must have initiated treatment prior to Step 2 entry.\n* Receipt of both bNAb infusions or placebo infusions during Step 1.\n* HIV-1 RNA \\\u003C200 copies\u002FmL obtained within 6 weeks prior to Step 2 registration at any Network-approved non-US laboratory that is VQA certified.\n* CD4+ T cell count ≥450 cells\u002Fmm3 obtained within 6 weeks prior to Step 2 registration at any Network-approved non-US laboratory that is IQA certified.\n* For participants of child-bearing potential, negative serum or urine pregnancy test within 48 hours prior to Step 2 entry at any Network-approved non-US laboratory or clinic that operates in accordance with GCLP and participates in appropriate EQA programs.\n* Ability and willingness to use a barrier method of contraception or abstinence from sexual intercourse during Steps 2 and 3, and until plasma HIV-1 RNA is less than limit of detection, with all partners who are without HIV or whose serostatus is unknown in order to prevent HIV transmission to sexual partners.\n* Ability and willingness to stop ART.\n\nStep 3 Inclusion Criteria\n\n* Has not met ART restart criteria.\n* Completion of protocol Step 2.\n* Willing to continue ATI.\n\nStep 4 Inclusion Criteria\n\n* Met ART restart criteria (section 3.0) during Step 2 or Step 3 OR Completed Step 3 and is not enrolling to ACTG A5385.\n\nStep 1 Exclusion Criteria:\n\n* Any clinically significant acute or chronic medical condition, other than HIV, that in the opinion of the investigator would preclude safe participation in the study or interfere with the validity of study results.\n* Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the preceding 36 months or for whom such therapies are expected in the subsequent 12 months. \\[NOTE: Minor surgical removal of localized skin cancers (squamous cell carcinoma, basal cell carcinoma) are not exclusionary.\\]\n* History of AIDS-defining illness within 3 years prior to enrollment.\n* History of systemic corticosteroids (e.g., an equivalent dose of prednisone of \\> 20 mg daily for \\>14 days), immunosuppressive anti-cancer, interleukins, systemic interferons, systemic chemotherapy or other medications considered significant by the trial physician within the last 12 weeks.\n* History of a severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis in the 2 years prior to enrollment.\n* History of chronic urticaria requiring current daily treatment.\n* Known history of active Hepatitis B or Hepatitis C infection. \\[NOTE: Participant is eligible if hepatitis C virus (HCV) cure or clearance is documented.\\]\n* History of or current clinical atherosclerotic cardiovascular disease (ASCVD), as defined by 2013 American College of Cardiology (ACC)\u002FAmerican Heart Association (AHA) 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* Any history of receipt of HIV vaccine candidate or HIV-specific monoclonal antibody therapy.\n* Participation in any clinical study of an investigational product within 28 days prior to study entry (day 0) or expected participation in such a study during participation in this study. \\[NOTE: Treatment or receipt of prophylaxis against other infectious pathogens such as SARS-CoV-2 or Monkeypox under Emergency Use Authorization within 28 days of study entry is not exclusionary.\\]\n* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n* Breastfeeding\n* Laboratory abnormalities in the parameters listed below, obtained by any Network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate EQA programs.\n\n  * Absolute neutrophil count \\\u003C750 cells\u002Fmm3\n  * Hemoglobin \\\u003C9 gm\u002FdL for volunteers who were assigned female sex at birth, \\\u003C10.0 g\u002FdL for volunteers who were assigned male sex at birth\n  * Platelet count \\\u003C100,000 cells\u002Fmm3\n  * ALT \\>3 x ULN\n  * AST \\>3 x ULN\n  * Total bilirubin \\>2 x ULN\n  * eGFR \\\u003C60 mL\u002Fmin\u002F1.73m2\n* Use of prohibited medications with ART within 7 days prior to study entry, or planned use of prohibited medications during the period of study participation.\n\n\\[NOTE: Use of St. John's wort within 7 days prior to study entry is acceptable but must be discontinued on the day of study entry\\]\n\nStep 2 Exclusion Criteria:\n\n* Viral failure after Step 1 week 24.\n* Participant never started ART.\n* Participant interrupted ART ≥7 consecutive days in Step 1.\n* Current use of an ART regimen that includes a long-acting or NNRTI component.\n* Intercurrent illness, new medical diagnosis, laboratory abnormality, sign, or symptom that, in the opinion of the site investigator, would place participant at higher risk of morbidity during ATI.\n* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n\nStep 3 Exclusion Criteria\n\n* Transfer to A5385 (The Post-Intervention Cohort Study) \\[NOTE: Participants may be offered co-enrollment or transfer to A5385, depending on ACTG identification of the preferred methodology for observation during extended ATI.\\]\n* Intercurrent illness, new medical diagnosis, laboratory abnormality, sign, or symptom that, in the opinion of the site investigator, would place participant at higher risk of morbidity during analytic treatment interruption.\n* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n\nStep 4 Exclusion Criteria\n\n* None",{"count":77,"type":22},135,[56],"For people living with HIV, antiretroviral therapy (ART) helps to stop the virus from multiplying. The goal of current HIV treatment is to have such a small amount of the virus in the blood that it does not show up on regular tests. HIV is also hidden in cells throughout the body and can start multiplying when ART is stopped.\n\nThis research study will test two new study drugs: 10-1074-LS and 3BNC117-LS. Both of these study drugs are antibodies against HIV. An antibody is generally a substance that the body makes in response to an infection. The antibodies being used in this study were made in a laboratory and were designed to attach to HIV and can block HIV from attacking cells in the body and from spreading to other parts of the body. These antibodies are being developed to potentially treat and prevent HIV.\n\nThe main purpose of this study is to see if the study drugs affect the level of HIV that remains in the blood cells while taking ART and the level of HIV in the blood after discontinuing taking ART. The study will also see if it is safe to give people these antibodies and if they cause any side effects.",[81],"HIV-1-infection","2025-01-30",{"date":84,"type":34},"2025-01-31",{"date":86,"type":34},"2025-01-17",{"date":88,"type":22},"2029-02-16",{"name":40,"class":41},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":5},"100514987","observational-pic-destination-cohort-100514987","NCT05985642","Observational PIC Destination Cohort","An Observational Post-Intervention Control Destination Cohort","Step 1 Inclusion Criteria:\n\n* Currently or previously enrolled in a qualifying ACTG or non- ACTG parent study of curative or suppressive HIV therapy that included an ATI.\n* If feasible, participants should not remain co-enrolled in their respective parent study after entering A5385.\n* Achieved at least 24 weeks of HIV virus suppression (as defined by the parent study) following ATI initiation, remains off ART with \\\u003C4 consecutive weeks of HIV-1 RNA \\>1000 copies\u002FmL, CD4+ T-cell count \\> 350 cells\u002Fmm3 and not experiencing symptoms of acute retroviral syndrome.\n\nNOTE: Participants whose participation has ended on the parent study may still qualify if they have not resumed ART, meet A5385's eligibility criteria, and have not met A5385 ART restart criteria.\n\n* CD4+ T cell count \\>350 cells\u002Fmm3 obtained within 28 days prior to study entry at any US laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent, or at any network-approved non-US laboratory that is IQA certified.\n* Willingness to continue ATI for up to 96 weeks or until ART restart criteria are met, and to remain in follow up for 48 weeks after ART restart.\n* For participants who are able to become pregnant, negative serum or urine pregnancy test within 24 hours prior to study entry by any US clinic or laboratory that has a CLIA certification or its equivalent, or is using a point of care (POC)\u002FCLIA-waived test, or at any network-approved non-US laboratory or clinic that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs.\n\nNOTE A: Participants who are able to become pregnant are individuals who have not been post-menopausal for at least 24 consecutive months, who have had menses within the preceding 24 months, and who have not undergone surgical sterilization, specifically hysterectomy and\u002For bilateral oophorectomy, tubal ligation, or bilateral salpingectomy.\n\nNOTE B: Acceptable documentation of hysterectomy and bilateral oophorectomy, tubal ligation, and tubal micro-inserts: written documentation or oral communication from a clinician or clinician's staff documented in source documents (physician report\u002Fletter, operative report or other source documentation in the patient record, discharge summary, laboratory report, etc.). Participant-reported history is acceptable for documentation of menopause.\n\n* Participants who are able to become pregnant and are engaging in sexual activity that could lead to pregnancy must agree to use one highly effective method of contraception throughout the course of the study from the list below.\n\nAcceptable methods of contraception include:\n\n* Barrier method\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* Male partner sterilization with documentation of azoospermia prior to the female participant's entry into the study, and this male is the sole partner for that participant.\n\n  * Willingness to use barrier protection (male or female) during sexual activity with all partners not on effective pre-exposure prophylaxis (PrEP) throughout Step 1 ATI and until viral re-suppression in Step 2.\n\nNOTE: Effective PrEP includes ART treatment for partners living with HIV infection.\n\n* Ability and willingness of participant to provide informed consent.\n\nStep 2 Inclusion Criteria:\n\n* Met A5385 ART restart criteria in Step 1.\n* Willingness to use barrier protection (male or female) during sexual activity with all partners not on effective PrEP until viral re-suppression.\n\nNOTE: Effective PrEP includes ART treatment for partners living with HIV infection.\n\nStep 1 Exclusion Criteria:\n\n* Intercurrent illness, new medical diagnosis, laboratory abnormality, sign, or symptom that, in the opinion of the site investigator, would place participant at higher risk of morbidity during continued ATI.\n* Medical or psychiatric condition (including pregnancy or breastfeeding) that, in the opinion of the site investigator, would place the participant at higher risk of morbidity or would interfere with adherence to study requirements.\n\nNOTE: Site investigators should exercise caution in invoking these criteria and instead aim to support potential participants who are interested and otherwise eligible to participate in the study.\n\nStep 2 Exclusion Criteria:\n\n* Medical or psychiatric condition that, in the opinion of the site investigator, would place the participant at higher risk of morbidity or would interfere with adherence to study requirements.\n\nNOTE: Site investigators should exercise caution in invoking these criteria and instead aim to support potential participants who are interested and otherwise eligible to participate in the study.",{"count":98,"type":22},30,"OBSERVATIONAL","This study is being done to see if people who control HIV without antiretroviral therapy (ART) after receiving an intervention can remain off ART safely. The information collected in this study is also being used to try to understand how people control HIV without ART after receiving an intervention.",[81],"2024-12-10",{"date":104,"type":34},"2024-12-13",{"date":106,"type":34},"2024-03-19",{"date":108,"type":22},"2029-09-03",{"name":40,"class":41},""]