[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hiv-i-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hiv-i-infection":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,50,82,107,135,159,182],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100578004","phase-2-multi-interventional-approaches-to-mitigate-hiv-reservoirs-aiming-the-sustained-hiv-remission-without-antiretrovirals-100578004",false,"NCT06805656","Multi Interventional Approaches to Mitigate HIV Reservoirs Aiming the Sustained HIV Remission Without Antiretrovirals","Multi Interventional Approaches to Mitigate HIV Reservoirs Aiming the Sustained HIV Remission Without Use of Antiretrovirals","Inclusion Criteria:\n\n\\- \\> 18 years old \\\u003C 65 years old Documented HIV-1 infection. Has voluntarily signed ICF. On HAART ≥ 2 years, without changes in the 24 weeks immediately prior to screening.\n\nHIV viral load \\\u003C50 copies\u002FmL, and never \\> 50 copies\u002FmL on 2 consecutive occasions in the last 2 years. CD4 count nadir.\n\n\\> 350 cells\u002F mm3 Current CD4 count \\> 500 cells\u002F mm3. R5 HIV-1 at Screening as defined by proviral DNA genotropism.\n\nExclusion Criteria:\n\n\\- Any evidence of an active AIDS-defining condition. Any significant acute medical illness in the past 8 weeks. Women who are pregnant or breastfeeding. Use of any of the following within 90 days prior to entry: systemic cytotoxic chemotherapy; investigational agents; immunomodulators (colonystimulating factors, growth factors, systemic corticosteroids, HIV vaccines, immune globulin, interleukins, interferons); coumadin, warfarin, or other coumadin derivative anticoagulants. Use of an agent definitely or possibly associated with effects on QT intervals: amiodarone, arsenic trioxide, astemizole, bepridil, chloroquine, chlorpromazine, cisapride, clarithromycin, disopyramide, dofetilide, domperidone, droperidol, erythromycin, halofantrine, haloperidol, ibutilide, levomethadyl, mesoridazine, methadone, pentamidine, pimozide, probucol, procainamide, quinidine, sotalol, sparfloxacin, terfenadine, thioridazine.\n\nReceipt of compounds with HDAC inhibitor-like activity, such as valproic acid or nicotinamide within the last 30 days. Potential participants may enroll after a 30-day washout period.\n\nKnown hypersensitivity to the components of gold salt, nicotinamide or its analogs.\n\nHepatitis B (HBsAg +) or Hepatitis C (HCV RNA +) infection. Known renal insufficiency defined as calculated creatinine clearance (Cockcroft Gault formula) \\\u003C60 mL\u002Fmin.\n\nSubjects with a laboratory abnormality grade 3 or 4 with the following exceptions: pancreatic amylase, cholesterol, triglyceride, gamma glutamyl transpeptidase, bilirubin.\n\nAny condition which, in the investigators opinion, could compromise the subject's safety or adherence to the trial protocol.","ALL","18 Years","65 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","A modern and urgent challenge in fighting HIV infection is to achieve sustained HIV remission without the use of antiretrovirals. The investigators' preliminary data indicate that the use of combined strategies to mitigate the HIV proviral reservoir size among individuals with suppressive antiretroviral treatment achieved unprecedented results in the reduction of HIV DNA present in these cells and in the reduction of CD4 + and CD8 + T cell activation. Combined interventions include intensified antiretroviral treatment to mitigate residual HIV replication, use of a histone deacetylase inhibitor to interrupt viral latency, use of an anti-proliferative medication to reduce long-lived T cells that harbor HIV and a personalized dendritic cell therapy vaccine to eliminate cells with latent HIV infection or cells present in viral sanctuaries. Due to the good results obtained in the exploratory stage of the project, the investigators propose to expand it by recruiting a larger number of patient to confirm the previously obtained results and to generate new insights related to the mechanisms involved in viral latency, latency disruption and the effects of analytical treatment interruption of antiretrovirals among patients undergoing all above mentioned interventions.",[27,28],"Hiv","HIV I Infection",[30,31,32,33,34,35,36],"Dendritic Cell vaccination","antiretroviral intensification","Auranofin","Histone Deacetylase Inhibitor","residual viral replication","HIV sanctuaries","HIV latency","NOT_YET_RECRUITING","2026-05-28",{"date":40,"type":41},"2026-06-01","ACTUAL",{"date":43,"type":21},"2026-07-01",{"date":45,"type":21},"2027-12-31",{"name":47,"class":48},"Federal University of São Paulo","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":16,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100512087","phase-2-evaluating-the-safety-and-immunogenicity-of-mtbvac-100512087","NCT05947890","Evaluating the Safety and Immunogenicity of MTBVAC","A Phase 2a Clinical Trial to Evaluate the Safety and Immunogenicity of MTBVAC","HVTN605A5421","Inclusion Criteria:\n\n* Age of 12 through 55 years, on the day of enrollment.\n* Access to a participating HVTN or ACTG CRS and willingness to be followed for the planned duration of the study.\n* For volunteers 18 years of age or older: ability and willingness to provide informed consent.\n* For volunteers less than 18 years of age: parent or legal guardian is willing and able to provide informed consent for potential participant's study participation; in addition, when applicable per ethics committee policies and procedures, potential participant is willing and able to provide written assent for study participation.\n* Assessment of Understanding (AoU): volunteer demonstrates understanding of this study and completes a questionnaire prior to vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly.\n* Prior receipt of BCG vaccine in infancy as determined by the site investigator.\n* Agrees not to enroll in another study of an investigational study product until after the last scheduled clinic visit. If a potential participant is already enrolled in another clinical trial, approvals from the other trial sponsor and the HVTN 605\u002FA5421 PSRT are required prior to enrollment into HVTN 605\u002FA5421.\n* Good general health as shown by medical history, physical exam, and screening laboratory tests and assessed by the site investigator.\n* Willingness to receive HIV-related test results.\n* For volunteers living without HIV:\n\n  1. Negative HIV-1 and -2 blood test: Non-US sites may use locally available assays that have been approved by HVTN Laboratory Operations\n  2. Assessed by the clinic staff as having a low likelihood of acquiring HIV and is committed to maintaining behavior that is consistent with a lower likelihood of acquiring HIV through the last required protocol clinic visit\n  3. Willingness to discuss their potential for HIV acquisition and is amenable to HIV risk reduction counseling\n* For volunteers living with HIV:\n\n  1. For both Cohorts 2 and 3: Completed one course of tuberculosis preventive treatment (TPT) as determined by the site investigator.\n\n     Documented HIV viral suppression (Plasma HIV levels \\\u003C 50 copies\u002FmL) collected at least three months and up to 15 months prior to enrollment (with no intervening HIV-1 RNA results ≥ 50 copies\u002FmL) and from screening labs.\n\n     Has been receiving at least 6 months of ART prior to enrollment, as determined by the site investigator\n  2. For Cohort 2: WHO HIV clinical stage 1 or 2 prior to initiation (or re-initiation in case of treatment interruption\u002Fdefault) of ART.\n\nCD4+ T-cell count of ≥ 200 cells\u002Fmm3 (during screening) 3. For Cohort 3: Advanced HIV disease (defined as CD4 count less than 200 cells\u002Fmm3 or WHO HIV clinical stage 3 or 4) prior to initiation (or re-initiation) of ART. Advanced HIV defined as CD4 count less than 200 cells\u002Fmm3 or WHO stage 3 or 4. Current CD4+ T-cell count of ≥ 100 cells\u002F mm3 (during screening)\n\n* Laboratory Inclusion Values - Has normal or Grade 1 results of all of the following at screening:\n\nHemoglobin (≥ 9.5 g\u002FdL or ≥ 5.88 mmol\u002FL for males and females less than 13 years of age; ≥ 9.5 g\u002FdL or ≥ 5.88 mmol\u002FL for females 13 years of age and older; ≥ 10.0 g\u002FdL or ≥ 6.19 mmol\u002FL for males 13 years of age and older); White blood cell count (≥ 2000 cells\u002Fmm3 or ≥ 2.000 × 109 cells\u002FL); Platelet count (≥ 100,000 cells\u002Fmm3 or ≥ 100.000 × 109 cells\u002FL); Creatinine (≤ 1.3 × upper limit of normal \\[ULN\\]); Alanine aminotransferase (ALT) (\\\u003C 2.5 × ULN); Aspartate aminotransferase (AST) (\\\u003C 2.5 × ULN)\n\n* Negative Hepatitis B surface antigen (HBsAg).\n* Negative anti-Hepatitis C virus Abs (anti-HCV), or negative HCV nucleic acid test if the anti-HCV is positive\n* For volunteers assigned female sex at birth (AFAB) or intersex at birth and are of reproductive potential (hereafter referred to as \"of pregnancy potential\"): negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test at screening (ie, prior to randomization) and prior to study product administration on the day of study product administration. Persons who are NOT of pregnancy potential including having reached menopause (no menses for 1 year) or having undergone hysterectomy or bilateral oophorectomy, or tubal ligation (verified by medical records) are not required to undergo pregnancy testing.\n* Reproductive status: A volunteer of pregnancy potential:\n\n  1. Must agree to use effective contraception for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment until 10 weeks after vaccination.\n  2. Volunteers of pregnancy potential must also agree not to seek pregnancy through alternative methods, such as artificial insemination, or in vitro fertilization until 10 weeks after vaccination.\n  3. Volunteers of pregnancy potential must also agree not to undergo oocyte retrieval.\n\nExclusion Criteria:\n\n* Weight less than 40 kg\n* Known significant exposure to TB or receipt of tuberculin skin test in the six months prior enrollment, as determined by the site investigator based on potential participant\u002Fparent\u002Fguardian report and available medical records. \\[Note: Significant exposure is defined as close contact with a person who has active TB and has not completed TB treatment. Close contact is defined as sleeping in the same contiguous house\u002Fdwelling, and\u002For working or socializing in close proximity in an enclosed space frequently (eg, several times a week).\\]\n* History of prior active TB disease, as determined by the site investigator based on participant\u002Fparent\u002Fguardian report and available medical, laboratory or radiographic records.\n* Evidence of active TB disease as determined by the site investigator based on participant\u002Fparent\u002Fguardian report and available medical records, results from physical examination, two-view chest X-ray, and M.tb nucleic acid testing from an expectorated sputum, including a review of any available radiography; and, for volunteers living with HIV and a CD4 count \\\u003C200 cells\u002Fmm3, a positive urine LAM test.\n* Receipt of TB preventive therapy within 28 days prior to enrollment or expected to initiate TB preventive therapy during the study as determined by the site investigator based on participant\u002Fparent\u002Fguardian report and available medical records Note: Clinical indication for receipt of TB preventive therapy will be determined by the site investigator consistent with local standard guidelines. Potential participants on TB preventive therapy during screening may be enrolled once the exclusionary timeframes indicated above have elapsed. If the screening period is exceeded while this requirement is being met, a new screening attempt should be initiated.\n* For volunteers living with HIV: current active AIDS-defining condition as determined by the site investigator based on participant\u002Fparent\u002Fguardian report and available medical records\n* Blood products received within 120 days before vaccination.\n* Investigational study products (non-vaccine) received within 28 days before vaccination.\n* Pregnant or breastfeeding.\n* Investigational TB vaccine(s) received in a prior TB vaccine trial or BCG vaccination outside infancy. For volunteers who have received control\u002Fplacebo in a TB vaccine trial, the HVTN 605\u002FA5421 PSRT will determine eligibility on a case-by-case basis.\n* Investigational non-TB vaccine(s) received within the last 1 year in a prior vaccine trial. Exceptions may be made by the HVTN 605\u002FA5421 PSRT for vaccines that have subsequently undergone licensure by the FDA or by the national regulatory authority where the volunteer is enrolling. For volunteers who have received control\u002Fplacebo in an experimental vaccine trial, the HVTN 605\u002FA5421 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 1 years ago, eligibility for enrollment will be determined by the HVTN 605\u002FA5421 PSRT on a case-by-case basis.\n* Live attenuated vaccines received within 28 days before first vaccination or scheduled within 28 days after injection (eg, measles, mumps, and rubella \\[MMR\\]; oral polio vaccine \\[OPV\\]; varicella; yellow fever; live attenuated influenza vaccine).\n* Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B).\n* Allergy treatment with antigen injections within 28 days before first vaccination or that are scheduled within 14 days after first vaccination.\n* Immunosuppressive medications received within 168 days before first vaccination (Not exclusionary: \\[1\\] corticosteroid nasal spray; \\[2\\] inhaled corticosteroids; \\[3\\] topical corticosteroids for mild, uncomplicated dermatologic condition; or \\[4\\] a single course of oral\u002Fparenteral prednisone or equivalent at doses \\\u003C 60 mg\u002Fday and length of therapy \\\u003C 11 days with completion at least 30 days prior to enrollment).\n* Serious adverse reactions to vaccines or to vaccine components including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and\u002For abdominal pain. (Not excluded from participation: a volunteer who had a non-anaphylactic adverse reaction to pertussis vaccine as a child).\n* Immunoglobulin received within 90 days before vaccination.\n* Autoimmune disease, current or history (Not exclusionary: mild, well-controlled psoriasis)\n* Immunodeficiency (Not exclusionary: HIV).\n* Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:\n\n  1. A process that would affect the immune response,\n  2. A process that would require medication that affects the immune response,\n  3. Any contraindication to repeated injections or blood draws,\n  4. A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period,\n  5. A condition or process for which signs or symptoms could be confused with reactions to vaccine, or\n  6. Any condition specifically listed among the exclusion criteria below.\n* Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a volunteer's ability to give informed consent, including but not limited to clinically significant substance or alcohol use disorder.\n* Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.\n* Asthma exclusion criteria:\n\nAsthma is exclusionary if the participant has ANY of the following:\n\n1\\. Required either oral or parenteral corticosteroids for an exacerbation 2 or more times within the past year; OR 2. Needed emergency care, urgent care, hospitalization, or intubation for an acute asthma exacerbation within the past year (eg, would NOT exclude individuals with asthma who meet all other criteria but sought urgent\u002Femergent care solely for asthma medication refills or coexisting conditions unrelated to asthma); OR 3. Uses a short-acting rescue inhaler more than 2 days\u002Fweek for acute asthma symptoms (ie, not for preventive treatment prior to athletic activity); OR 4. Uses medium-to-high-dose inhaled corticosteroids (greater than 250 mcg fluticasone or therapeutic equivalent per day), whether in single-therapy or dual-therapy inhalers (ie, with a long-acting beta agonist \\[LABA\\]); OR Uses more than 1 medication for maintenance therapy daily. Inclusion of anyone on a stable dose of more than 1 medication for maintenance therapy daily for greater than 2 years requires PSRT approval.\n\n* Diabetes mellitus type 1 or type 2. (Not exclusionary: type 2 cases controlled with diet alone or a history of isolated gestational diabetes. For these cases, control should be confirmed with an appropriate laboratory test (eg, fasting glucose, HbA1c) based on a specimen collected during screening.)\n* Hypertension:\n\n  1. If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. Well-controlled blood pressure is defined in this protocol as consistently \\\u003C 140 mm Hg systolic and \\\u003C 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤ 150 mm Hg systolic and ≤ 100 mm Hg diastolic. For these volunteers, blood pressure must be \\\u003C 140 mm Hg systolic and \\\u003C 90 mm Hg diastolic at enrollment.\n  2. If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure ≥ 150 mm Hg at enrollment or diastolic blood pressure ≥ 100 mm Hg at enrollment.\n* Bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions)\n* Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the study).\n* Seizure disorder: History of seizure(s) within past three years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.\n* Asplenia: any condition resulting in the absence of a functional spleen.\n* History of angioedema or anaphylaxis (Not exclusionary: angioedema or anaphylaxis with known trigger and no episodes within five years.)\n* History of generalized urticaria within past five years.",true,"12 Years","55 Years",{"count":62,"type":21},276,[24],"The purpose of this study is to evaluate the safety and immunogenicity of MTBVAC in adolescents and adults living with and without HIV in South Africa",[28,66],"Tuberculosis",[68,69],"HIV","TB","RECRUITING","2026-03-10",{"date":73,"type":41},"2026-03-12",{"date":75,"type":41},"2024-01-30",{"date":77,"type":21},"2027-04-05",{"name":79,"class":80},"HIV Vaccine Trials Network","NETWORK",16,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100580193","impact-of-pain-from-injectables-antiretroviral-treatments-in-hiv-1-patients-based-on-the-injection-site-ventrogluteal-or-dorsogluteal-and-the-use-or-non-use-of-virtual-reality-headset-100580193","NCT06834113","Impact of Pain From Injectables Antiretroviral Treatments in HIV-1 Patients Based on the Injection Site (Ventrogluteal or Dorsogluteal) and the Use or Non-use of Virtual Reality Headset","Impact of Two Types of Interventions (Ventrogluteal Versus Dorsogluteal Injection Site; Virtual Reality Headset: Presence or Absence) on Pain After Injections of Vocabria® (Cabotegravir) and Rekambys® (Rilpivirine) in Patients Infected With Human Immunodeficiency Virus -1","VIHINJECT","Inclusion Criteria:\n\n* Patient aged at least 18 years;\n* Patient infected with HIV-1;\n* Patient virologically controlled (VL \\\u003C 50 copies\u002Fml);\n* Patient scheduled to receive treatment with cabotegravir and rilpivirine (naïve patients) or currently on injectable cabotegravir and rilpivirine, prescribed by their referring physician.\n\nExclusion Criteria:\n\n* Patient(s) on another injectable antiretroviral treatment;\n* Patient participating in another clinical trial with medication;\n* Patient(s) with epilepsy;\n* Patient on antidepressant treatment;\n* Patient(s) with psychiatric or behavioral disorders;\n* Patient(s) with a history of dizziness and motion sickness that prevents the use of virtual reality headset;\n* Patient(s) with visual and hearing impairments that prevent the use of virtual reality headset;\n* Patient(s) deprived of liberty, under guardianship or under curatorship;\n* Patient(s) not affiliated with a social security scheme;\n* Pregnant or breastfeeding women.",{"count":91,"type":21},120,[93],"NA","This is a multicenter, randomized, open-label study with a cross-over design. The objective of this project is to compare the intensity of pain induced by injectable antiretroviral (ARV) treatment (Cabotegravir® and Rilpivirine®) in patients infected with HIV-1, depending on the injection site and whether or not they are wearing a virtual reality headset. The reference group being the dorsogluteal injection without headset.\n\nParticipants who meet the study criteria will be randomized into 1 of 24 sequences. A sequence is composed by 4 injections procedures: dorsogluteal intramuscular injection (A), ventrogluteal intramuscular injection (B), dorsogluteal intramuscular injection with virtual reality headset (C), ventrogluteal intramuscular injection with virtual reality headset (D).\n\nEach patient will be their own witness and will experience the 4 intramuscular injection procedures of injectable antiretroviral.\n\nThe study population are patients carrying HIV-1 and being monitored for this pathology, eligible (naïve patients) or already under Cabotegravir® (CAB) and Rilpivirine® (RPV) injectable treatment.",[28,96],"Injection Pain","2025-12-22",{"date":99,"type":41},"2025-12-30",{"date":101,"type":41},"2025-01-24",{"date":103,"type":21},"2026-09-24",{"name":105,"class":48},"Centre Hospitalier Régional d'Orléans",5,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100453660","phase-1-low-dose-nivolumab-in-adults-living-with-hiv-on-antiretroviral-therapy-100453660","NCT05187429","Low Dose Nivolumab in Adults Living With HIV on Antiretroviral Therapy","Safety, Immunogenicity and Efficacy of Low Dose Nivolumab in Adults Living With HIV on Antiretroviral Therapy (ART)","NIVO-LD","Inclusion Criteria:\n\n* Documented HIV-1 infection;\n* Viral load \\> 400 copies\u002FmL prior to initiation of ART;\n* Weight ≥ 50 kg;\n* Ability and willingness to provide informed consent and to continue ART throughout the study;\n* Receiving combination ART for at least 2 years and being on the same ART regimen for at least 4 weeks at the screening visit;\n* HIV-1 plasma RNA \\\u003C50 copies\u002FmL for \\>2 years (documented on at least 2 occasions within the 2 years) and \\\u003C50 copies\u002FmL at screening. Episodes of a single HIV plasma RNA 50-500 copies\u002FmL will not exclude participation if the subsequent HIV plasma RNA was \\\u003C50 copies\u002FmL;\n* CD4+ T cell counts \\>500 cells\u002FμL at screening;\n* Female participants if they meet one of the following criteria:\n\n  * Is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or,\n  * Is of child-bearing potential with a negative pregnancy test at both Screening and Day 0 and agrees to use one of the following methods of contraception to avoid pregnancy from 14 days prior to the first infusion until the end of the study:\n\n    * Complete abstinence from penile-vaginal intercourse;\n    * Double barrier method (male condom\u002Fspermicide, male condom\u002Fdiaphragm, diaphragm\u002Fspermicide);\n    * Any intrauterine device (IUD) with published data showing that the expected failure rate is \\\u003C1% per year;\n    * Male partner sterilization confirmed prior to the female participant's entry into the study, and this male is the sole partner for that participant;\n    * Approved hormonal contraception (Where other medications to be used in the study (e.g., efavirenz and darunavir) are known, or are likely, to significantly interact with systemic contraceptives, resulting in decreased efficacy of the contraceptive, then alternative methods of non-hormonal contraception are recommended);\n    * Any other method with published data showing that the expected failure rate is \\\u003C1% per year. Note: If using one of the described contraception methods it must be used consistently, in accordance with the approved product label and all female participants must be willing to undergo urine pregnancy tests as specified in the Schedule of Procedures.\n* 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) during the study;\n* Heterosexually active male if they are;\n\n  * willing to use an effective method of contraception (anatomical sterility in self that is confirmed prior to study entry) or\n  * agree on the use of an effective method of contraception with an effective failure rate of \\\u003C 1% by his partner (hormonal contraception, intra-uterine device (IUD), or anatomical sterility) from the day of the first infusion until the end of study (as long as plasma viral load \\\u003C20c\u002FmL).\n* Singapore only: all participants must understand and agree to abide by the Infectious Diseases Act, in particular Part 4 'Control of HIV infection' inclusive of section 23 'Sexual activity by person with HIV infection'\n\nExclusion Criteria:\n\n* Active, known and suspected autoimmune disease (including but not limited to including but not limited to inflammatory bowel diseases, scleroderma, severe psoriasis, myocarditis, uveitis, pneumonitis, systemic lupus erythematosus, rheumatoid arthritis, optic neuritis, myasthenia gravis, adrenal insufficiency, hypothyroidism and\u002For hyperthyroidism, autoimmune thyroiditis, sarcoidosis, and vitiligo);\n* History of interstitial lung disease;\n* History of chronic obstructive pulmonary disease (COPD);\n* Type I diabetes mellitus;\n* Active malignancy or history of malignancy requiring systemic chemotherapy or surgery in the preceding 24 months; exception -history of excised localized non-melanomatous skin cancers (squamous cell carcinoma, basal cell carcinoma);\n* History of solid organ transplant. Note Individuals with prior corneal transplants may be allowed to enroll after discussion with and approval from the study principal investigator;\n* Active or previously treated active TB;\n* History of HIV-related opportunistic infection within the last years prior to study entry;\n* Prior history of immune reconstitution syndrome (IRIS);\n* Current, chronic, acute or recurrent bacterial, fungal or viral (other than HIV) infections that are serious, in the opinion of the investigator, and require systemic therapy within 30 days prior to study entry;\n* Immune deficiency other than that caused by HIV infection;\n* Received investigational drug or device within 6 months prior to study entry\n* Treatment for hepatitis C virus (HCV) within 6 months prior to study entry;\n* History of previous treatment with an immune checkpoint inhibitor;\n* History of prior immunoglobulin (IgG) therapy;\n* Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), systemic cytotoxic chemotherapy, experimental vaccines or investigational therapy within 60 days prior to study entry or intent to use immunomodulators during the study. NOTE: Participants receiving stable physiologic glucocorticoid doses, defined as prednisolone less than or equal to 10 mg\u002Fday or the equivalent, will not be excluded. Stable physiologic glucocorticoid doses should not be discontinued for the duration of the study. In addition, participants receiving inhaled or topical corticosteroids will not be excluded;\n* Any other current or prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study;\n* Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification;\n* Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones);\n* Participants who intend to modify their ART regimen within the study period;\n* Active alcohol or substance use that in the opinion of the investigator will prevent adequate compliance with study procedures;\n* Any acute or chronic psychiatric problems that, in the opinion of the investigator, make the participant ineligible for participation;\n* Any active, clinically significant medical condition not otherwise covered;\n* Women who are pregnant or breastfeeding or Women of Child Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy as specified in the inclusion criteria;\n* Men of reproductive potential who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy as specified in the inclusion criteria;\n* Specific exclusion criteria for Cohort A (Fine Needle Biopsy):\n\n  * prothrombin time (PTT) \\>2x ULN\n  * international normalized ratio (INR) \\>1.5\n  * Platelets \\\u003C50,000\u002Fmm3\n  * Chronic venous stasis of lower extremities\n  * Lower extremity lymphedema\n  * Allergies to local anesthetic\n  * Blood coagulation disorder.\n* The following laboratory abnormalities (lab tests may be repeated to obtain acceptable values before failure at screening is concluded);\n\n  * Hematology:\n\n    * Hemoglobin \\\u003C 14.0 g\u002FdL for men and \\\u003C12.0 g\u002FdL for women;\n    * Absolute Neutrophil Count (ANC) ≤ 1,500 \u002Fmm\\^3 (≤ 1 x 10\\^9\u002FL);\n    * Platelets ≤ 150,000 \u002Fmm\\^3\n  * Biochemistry:\n\n    * Aspartate aminotransferase (AST) \\> 1.25 x ULN;\n    * Alanine aminotransferase (ALT) \\> 1.25 x ULN;\n    * Bilirubin ≥1.5 x ULN (if on atazanavir ≥5 x ULN);\n    * Interferon-gamma release assay (IGRA) for tuberculosis (TB) with negative results within 90 days prior to study entry\n    * Thyroid stimulating hormone (TSH) outside the normal reference range;\n    * Free thyroxine (T4) outside the normal reference range\n    * Presence of Anti-thyroid peroxidase (TPO) antibodies;\n    * Presence of anti-glutamic acid decarboxylase (GAD) antibodies\n    * Antinuclear antibody (ANA) \\>1:80 at screening\n    * Early morning (8-9 am) cortisol outside the normal reference range. Note: female participants on estrogen-containing oral contraception or other exogenous estrogen treatment may repeat the AM cortisol as part of screening to determine eligibility;\n    * Fasting blood sugar \\> 7.0 mmol\u002FL (unless already diagnosed with Type 2 Diabetes Mellitus);\n  * Microbiology:\n\n    * Positive for hepatitis B surface antigen;\n    * Positive for hepatitis C antibody, unless confirmed clearance of HCV infection (spontaneous or following treatment) by polymerase chain reaction (PCR) testing.",{"count":116,"type":21},42,[118,24],"PHASE1","The purpose of this study is to evaluate whether a single dose of Nivolumab in people living with HIV can reduce the latent reservoir. The latent HIV reservoir is a group of immune system cells in the body that are infected with HIV but are not actively producing new virus. This is the reason why people living with HIV are unable to stop their antiretroviral treatment.",[28],[68,122,123,124,125],"Antiretroviral interruption","ATI","Low dose Nivolumab","Clinical Trial","2025-12-15",{"date":97,"type":41},{"date":129,"type":41},"2023-01-24",{"date":131,"type":21},"2029-01",{"name":133,"class":48},"University of Melbourne",2,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":158},"100484623","phase-2-tnf-inhibitors-to-reduce-mortality-in-hiv-1-infected-patients-with-tuberculosis-meningitis-100484623","NCT05590455","Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis","ANRS 12404 TIMPANI: Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis: a Phase II, Multicenter, Randomized Clinical Trial","TIMPANI","Inclusion Criteria:\n\n* Age ≥18 years\n* HIV-1 infection\n* Definite or probable tuberculosis meningitis\n* Standard tuberculosis meningitis treatment ≤3 days: anti TB drugs at standard doses and high-dose dexamethasone as per WHO guidelines\n* Signed informed consent form by patient or relative.\n\nExclusion Criteria:\n\n* Other concomitant neurological infection, i.e. toxoplasmosis, cryptococcosis, progressive multifocal leukoencephalopathy, bacterial meningitis, neuro-syphilis\n* Asymptomatic positive cryptococcal antigen in serum\n* HBsAg positive or anti hepatitis C virus antibodies positive\n* Alanine transaminase (ALT)\\>5 ULN\n* Rifampicin-resistant TB detected by GeneXpert MTB\u002FRIF Ultra\n* History of previous TB treatment in patients with GeneXpert MTB\u002FRIF Ultra negative or unavailable\n* Current use of drugs contraindicated with study drugs and that cannot be safely stopped\n* Allergy to study drugs or any of their components\n* Uncontrolled opportunistic infection\n* Moderate to severe cardiac insufficiency (NYHA classes III \u002F IV)\n* Any condition which might, in the investigator's opinion, compromise the safety of treatment and\u002For patient's adherence to study procedures\n* For women of childbearing age: 1) Pregnancy or breastfeeding; 2) Refusal to use effective contraception to be discussed with the investigator\n* Subjects participating in another clinical trial evaluating therapies and including an exclusion period that is still in force during the screening phase\n* Person under guardianship, or deprived of freedom by a judicial or administrative decision",{"count":144,"type":21},130,[24],"Randomized phase II clinical trial which aims to assess the impact on 3-month mortality and safety of adding adalimumab to standard treatment (anti-tuberculosis drugs and corticosteroids) in HIV patients with tuberculosis meningitis in 3 countries (Brazil, Mozambique, and Zambia).",[148,28],"Tuberculous Meningitis","2025-12-08",{"date":126,"type":41},{"date":152,"type":41},"2023-04-11",{"date":154,"type":21},"2027-12",{"name":156,"class":157},"ANRS, Emerging Infectious Diseases","OTHER_GOV",3,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":167,"targetDuration":169,"studyType":170,"phases":4,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":49},"100577518","real-world-use-of-lenacapavir-as-an-add-on-to-an-optimized-background-regimen-in-france-100577518","NCT06799338","Real World Use of Lenacapavir, as an add-on to an Optimized Background Regimen in France","Real World Use of Lenacapavir, as an add-on to an Optimized Background Regimen in France: a Retrospective Observational Study (LENAddOn)","LENAddON","Inclusion Criteria:\n\n* Adults (≥18 years);\n* With HIV-1 infection;\n* Who received a first dose of LEN (oral or injectable) with and OBR from the ending of the French national early access program (20 June 2023) to 30 June 2024;\n* Who did not refuse the collection and use of their data.\n\nExclusion Criteria:\n\n\\- HIV-2 infection.",{"count":168,"type":21},80,"52 Weeks","OBSERVATIONAL","For most people with HIV (PWH), an effective antiretroviral regimen can be devised. However, some PWH have multiple treatment failures due to viral resistance or unacceptable side effects to medication and no longer have durable viral suppression. People with multidrug-resistant HIV-1 are at increased risk for hospitalization, progression to acquired immunodeficiency syndrome, and death.\n\nLenacapavir (LEN) is a first-in-class capsid inhibitor and has been evaluated through the CAPELLA phase 3 trial in PWH with replicative multidrug-resistant HIV-1. In this trial, LEN combined with an optimized background regimen (OBR) led to high levels of viral suppression, as more than 80% of participants achieved undetectable plasma HIV-RNA, associated with increasing in CD4 T cell counts.\n\nLEN has become publicly available in France from June 20, 2023, and prescriptions are discussed and validated by multidisciplinary committees in the hospitals, including HIV physicians, virologists and pharmacologists.\n\nFrom the time LEN was made publicly available in France, no real-world data have been generated to describe the real-world use of LEN, in association with an OBR, in various patient's profiles who may differ from the subjects included the CAPELLA trial.\n\nThus, investigators plan to conduct a national, multicenter, retrospective observational study to describe baseline socio-demographic, clinical and biological profiles of PWH receiving LEN + OBR in French real-world settings, to determine the continuation of LEN injections at weeks 26 and 52, and to determine the reasons for stopping LEN in case of no continuation of LEN injections.\n\nIn its current indication, LEN is reserved for a minority of PWH. However, France is the second-largest prescribing country for this drug, and one year after it was first marketed, it seems essential to review its use. Whether LEN injections are continued 6 and 12 months after starting treatment is a crucial question for understanding its use in treatment centers.\n\nLenacapavir has become publicly available in France in June 20, 2023. LEN prescriptions in France are discussed and validated by multidisciplinary committees, including HIV physicians, virologists and pharmacologists in the hospitals.",[28],"2025-05-21",{"date":175,"type":41},"2025-05-22",{"date":177,"type":41},"2025-03-03",{"date":179,"type":21},"2025-12-31",{"name":181,"class":48},"Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":170,"phases":4,"briefSummary":191,"conditions":192,"keywords":193,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":4},"100564918","the-expand-study-pharmacist-administered-long-acting-cabotegravir--rilpivirine-to-expand-access-for-people-with-hiv-100564918","NCT06635421","The Expand Study-Pharmacist Administered Long Acting Cabotegravir + Rilpivirine to Expand Access for People With HIV","EXPAND","Patient Participant Inclusion Criteria:\n\n* 18 years of age and older\n* diagnosed with HIV by approved HIV screen and confirmation test\n* currently on CAB+RPV LA every 4 or 8 weeks\n* has received at least two doses of CAB+PRV LA\n* last HIV-1 RNA \\\u003C50 copies\u002Fml\n* no known or suspected resistance to either cabotegravir or rilpivirine\n* no plans to change medication in the next 48 weeks\n* no plans to move out of state\n* has plans to avoid pregnancy if of reproductive potential\n\nPatient Participant Exclusion Criteria:\n\n* individuals who are unable or unwilling to adhere to the study protocol\n* unable to speak\u002Fcomprehend English\n* insurance coverage for medication through medical benefit\n\nStaff Participant Inclusion\u002FExclusion Criteria:\n\n-all available staff involved in the CAB+RPV LA workflow will be approached for inclusion",{"count":190,"type":21},164,"The purpose of The EXPAND study is to develop and pilot a pharmacist led model of medication delivery. Following a co-design phase, patients may receive injections at satellite pharmacies by a licensed pharmacist. The acceptability, appropriateness, and feasibility of this approach and standard in clinic administration by a nurse will be assessed.",[28],[194,195,196,68,197],"long acting injectable antiretroviral therapy","cabotegravir","rilpivirine","pharmacist administered medication","2024-10-08",{"date":200,"type":41},"2024-10-10",{"date":202,"type":21},"2024-11-01",{"date":204,"type":21},"2026-12-31",{"name":206,"class":48},"MetroHealth Medical Center"]