[{"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":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,46,73,108,125,154,180,209,233,271,298,327,353,380],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100053770","phase-1-a-clinical-trial-to-look-at-the-safety-and-immune-responses-of-the-rna-based-vaccine-bnt168-in-adults-living-with-or-without-hiv-100053770",false,"NCT07698600","A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Adults Living With or Without HIV","A Randomized, Placebo-controlled, Phase I\u002FII Clinical Trial to Evaluate the Safety, Immunogenicity, and Impact on Virological Control of the Investigational RNA-based Vaccine BNT168 in Adults Living With or Without HIV","Key Inclusion Criteria:\n\n* Are 18 to 50 years of age inclusive at the time of giving informed consent.\n* For PLWOH: Individuals who are HIV-1 and HIV-2 negative at Visit 0. For PLWH: Individuals who are HIV-1 positive and HIV-2 negative at Visit 0.\n* Have not received an HIV vaccination or HIV broadly neutralizing antibody in another clinical study.\n* Are overall healthy as defined in the protocol.\n* Individuals who have screening hematology and\u002For blood chemistry laboratory values as defined in the protocol.\n* For PLWOH, starting at Visit 0 and continuously until the last planned visit in this study, individuals who:\n\n  * Are assessed by the investigator as having a low likelihood of acquiring HIV and are committed to avoiding behaviors associated with a higher likelihood of acquiring HIV until the End of Study Visit.\n  * Agree to discuss HIV disease risks.\n  * Agree to HIV infection risk reduction counseling.\n* For PLWH, individuals who:\n\n  * Have been on stable continuous cART for at least 12 months (defined as no interruptions longer than 14 continuous days) and with no changes in the components of the cART for at least 12 weeks prior to Visit 1.\n  * Are not on a non-nucleoside reverse transcriptase inhibitor at screening.\n  * Have never received lenacapavir and have not received other long-acting antiretroviral therapies in the last 2 years (i.e., intramuscular cabotegravir, cabotegravir-rilpivirine).\n  * Are willing to undergo HIV transmission risk reduction counseling and to maintain low-risk behavior to protect their partners.\n  * Have a CD4+ T cell count of ≥500 cells\u002FµL at Visit 0.\n  * Per medical history, any available prior CD4+ T cell count must be ≥350 cells\u002FµL.\n  * Have plasma HIV-1 RNA levels of \\\u003C50 cps\u002FmL for ≥6 months prior to study entry per investigator review of records and\u002For participant history (single measurements of \\\u003C200 cps\u002FmL are allowed if preceded and followed by values of \\\u003C50 cps\u002FmL).\n  * Are willing to stop cART and undergo ATI at the timepoint defined in the protocol.\n  * Are willing to re-initiate cART upon meeting cART restart criteria.\n  * Site investigator anticipates that a fully active alternative cART regimen could be constructed and would be available in the event of virologic failure on the participant's current cART regimen.\n* Agree not to donate blood from the time of first IMP administration until 90 days after the last IMP administration for PLWOH and until the End of Study Visit for PLWH.\n\nKey Exclusion Criteria:\n\n* Have had major surgery (e.g., major cardiopulmonary or abdominal operations) as per the investigator's judgment within 4 weeks before Visit 0, or will not have fully recovered from surgery, or have major surgery planned during the time the participants are expected to participate in the study.\n* Have an abnormal electrocardiogram at Visit 0 as specified in the protocol.\n* Have any existing condition which may affect IMP injection and\u002For assessment of local reactions, e.g., tattoos, severe scars, etc.\n* Have any bleeding diathesis or condition associated with prolonged bleeding that, in the opinion of the investigator, could compromise their wellbeing if they participate in the study.\n* Have any current febrile illness (body temperature \\>38.0°C\u002F\\>100.4°F) or other acute illness within 48 hours prior to IMP administration\n* Have any current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias, or any clinically significant cardiac disease per the investigator's judgment.\n* Have Grade ≥2 hypertension per Food and Drug Administration toxicity grading scale at screening.\n* Have a known or suspected impairment\u002Falteration of immune function, autoimmune disease, or immunodeficiency (except HIV for PLWH), including receipt of any immunostimulant, immunomodulator, immunosuppressive medication, immunoglobulin, or blood\u002Fplasma product within 60 days prior to Visit 1 or planned administration during the study. Use of inhaled, intranasal, topical, or locally injected corticosteroids (e.g., intraarticular or intrabursal administration) is acceptable.\n* Have a history of malignancy within 5 years before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered in the investigator's judgment to have minimal risk of recurrence. Any malignancy that is an AIDS-defining illness per protocol is exclusionary regardless of perceived risk of recurrence.\n* Have received any live vaccines within 28 days prior to Visit 0 or any other vaccines within 14 days prior to Visit 0 or who are planning to receive any vaccine within 28 days of each IMP dose. When possible, standard of care vaccinations should be planned with the study interventions in mind.\n* For PLWH: Have a history of opportunistic infections and\u002For AIDS-defining illnesses according to the US Centers for Disease Control and Prevention 2014 and the National Institutes of Health 2024.\n* For PLWOH: Have current untreated or incompletely treated active tuberculosis infection (by history or concerning symptoms). For PLWH: Have current untreated or incompletely treated active tuberculosis infection (by history or concerning symptoms or sputum molecular testing) or current latent tuberculosis infection (by blood interferon-gamma release assay \\[IGRA\\]). Not excluded: Participants who have a positive IGRA but were fully treated for latent or active tuberculosis infection, per history, review of available records, and per investigator discretion.\n* For PLWH: Have untreated or incompletely treated syphilis or genital, oropharyngeal or rectal gonorrhea or chlamydia infection.\n* For PLWH: Have a history of multi-class drug resistant HIV-1 infection defined as resistance to three or more classes of HIV drugs.\n* Have an estimated glomerular filtration rate of \\\u003C45 mL\u002Fmin\u002F1.73 m2 using the 2021 chronic kidney disease epidemiology creatinine equation.\n* History of any serious adverse reactions (including anaphylaxis, respiratory distress, angioedema, or urticaria) to vaccines or to vaccine components such as lipids.\n* Have a history of progressive or severe neurologic disorder, seizure disorder, or Guillain-Barré syndrome.\n* Have a history of diabetes mellitus type 1 or type 2, a screening hemoglobin A1c ≥6.5%, or are taking any medication for treatment of diabetes. (Not excluded: A history of isolated gestational diabetes.)\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.",true,"ALL","18 Years","50 Years",{"count":21,"type":22},126,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study will test a new ribonucleic acid (RNA)-based vaccine called BNT168 in adults living both with and without human immunodeficiency virus (HIV), to see how safe it is, how well it triggers the body's immune response and how it affects the amount of virus in the body.",[28],"HIV -1 Infection",[30,31,32,33],"HIV (human immunodeficiency virus)","combination antiretroviral therapy (cART)","Acquired immunodeficiency syndrome (AIDS)","Ribonucleic acid (RNA)-based vaccine","NOT_YET_RECRUITING","2026-07-07",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":22},"2026-07",{"date":42,"type":22},"2028-01",{"name":44,"class":45},"BioNTech SE","INDUSTRY",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100623110","phase-1-a-clinical-trial-investigating-the-safety-and-biological-activity-of-the-antibody-bnt351-in-adults-living-without-and-with-hiv-100623110","NCT07392372","A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV","A Phase I First-in-human Clinical Trial to Evaluate the Safety, Pharmacokinetics, and Antiviral Activity of the Broadly Neutralizing Antibody BNT351 in Adults Living Without and With HIV","Key Inclusion Criteria\n\nPart A:\n\n* Are HIV-1 and HIV-2 negative at Visit 0.\n* Starting at Visit 0 and continuously until the last planned visit in this study are individuals who:\n\n  1. Are assessed by the investigator as having a low likelihood of acquiring HIV and are committed to avoiding behaviors associated with a higher likelihood of acquiring HIV until the End of Study Visit.\n  2. Agree to discuss HIV disease risks;\n  3. Agree to HIV acquisition risk reduction counseling;\n\nPart B:\n\n* Are HIV-1 positive and HIV-2 negative at Visit 0.\n* Individuals who at Visit 0:\n\n  1. Are cART-naïve individuals who were diagnosed with HIV-1 infection ≤12 months prior to screening, OR are individuals who have discontinued cART and who were diagnosed with HIV-1 infection ≤12 months prior to screening or ≤18 months if this is found to be acceptable after discussion on a case-by-case basis with the sponsor's medical monitor.\n  2. If cART-experienced, have discontinued cART for at least 4 weeks before screening (if the individual was taking long-acting antiretroviral therapy \\[ART\\]), see the following bullet). For individuals who have discontinued cART: Are able to comply with study procedures and assessments in the investigator's judgment.\n  3. Have never received lenacapavir or ibalizumab or fostemsavir, and have not received other long-acting ARTs in the last 6 months (i.e., intramuscular cabotegravir, cabotegravir-rilpivirine).\n  4. Have a CD4+ T cell count of ≥500 cells\u002FµL and plasma HIV-1 RNA levels between 5,000-100,000 copies\u002FmL at screening.\n  5. Are willing to initiate cART at a protocol-defined timepoint (56 days post-dose, or earlier if meeting early cART start criteria or at investigator's discretion).\n  6. Are willing to undergo HIV transmission risk reduction counseling and to maintain low-risk behavior to protect their partners.\n\nKey Exclusion Criteria:\n\nParts A and B:\n\n* Have received an HIV vaccination or HIV broadly neutralizing antibody in another clinical study.\n* Have a known or suspected impairment\u002Falteration of immune function or immunodeficiency (except for HIV infection, applicable to Part B only), including receipt of any immunostimulant, immunomodulator, immunosuppressive medication, immunoglobulin, blood product, or oral or parenteral steroid within 60 days prior to Day 1 or planned administration during the study. The following exception applies: Use of inhaled, intranasal, topical, or locally injected corticosteroids (e.g., intraarticular or intrabursal administration) is allowed.\n* Have a history of generalized urticaria or angioedema, or of allergy, anaphylaxis, hypersensitivity or intolerance to a human or humanized antibody or to BNT351 excipients.\n\nPart B only:\n\n* Are receiving ongoing therapy for Mycobacterium tuberculosis infection.\n* Have a history of opportunistic infections\u002FAIDS-defining illnesses as defined in the protocol.\n* Have a history of multi-class drug resistant HIV-1 infection defined as resistance to three or more classes of HIV drugs.\n* Have a history of malignancy within 5 years before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered in the investigator's judgment to have minimal risk of recurrence. Any malignancy that is an AIDS-defining illness (as defined in the protocol) is exclusionary regardless of the perceived risk of recurrence.\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria apply.","65 Years",{"count":55,"type":22},67,[25],"This study will test the safety and blood levels of the antibody BNT351 in people living without and with human immunodeficiency virus (HIV). This study will also test the anti-viral activity of BNT351 in people living with HIV (PLWH) with detectable virus levels.\n\nThe main goals of this study are:\n\n* To learn about the safety of BNT351 and check for side effects.\n* To measure the amount of BNT351 antibody in blood over time.\n* To test the amount of HIV in the blood at different times after treatment with BNT351 in people living with HIV.",[28],[60,61,62],"HIV-1","Treatment of HIV-1 infection","Antibody","RECRUITING","2026-06-18",{"date":66,"type":38},"2026-06-22",{"date":68,"type":38},"2026-02-09",{"date":70,"type":22},"2027-06",{"name":44,"class":45},6,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100642060","phase-1-early-neutralizing-antibodies-in-infants-living-with-hiv-to-enhance-their-life-2-100642060","NCT07655141","Early Neutralizing Antibodies in Infants Living With HIV to Enhance Their Life (2)","A Phase 1\u002F2 Trial Evaluating the Safety, Pharmacokinetics, and Antiviral Activity of Subcutaneous ePGT121v1-LS in Combination With VRC07-523LS, Added to Standard Antiretroviral Therapy in Infants Living With HIV","ENABLE 2","Inclusion Criteria:\n\n* Infants from 1 to 365 days old at the time of enrolment.\n* Living with HIV-1, diagnosed with an approved assay detecting HIV nucleic acids in blood.\n* Weight \\> 2.5 kg at enrolment.\n* ART-naïve or ≤ 30 days of triple ART at screening (not including prophylaxis in HIV-exposed).\n* Clinically stable and can be managed as outpatient (participants identified in-hospital can start the trial at their first routine visit).\n* Parent or legal guardian able to provide Informed consent (IC).\n\nExclusion Criteria:\n\n* Participation in other concurrent research studies that, in the opinion of the principal investigator and central team, would interfere with the objectives of this study.\n* Previous receipt of bNAbs against HIV.\n* Serious Adverse Reactions (SARs) to the investigational medicinal product (IMP) or its components.\n* Intravenous (IV) immunoglobulins received within 90 days before IMP administration.\n* Any clinically significant acute or chronic illness or condition at screening that, in the opinion of the principal investigator\u002Fdesignee, renders the participant unfit to participate in the study or jeopardizes the safety or rights of the participant. Including, but not restricted to:\n* Evidence of active tuberculosis (TB) disease at the time of enrolment.\n* Life-threatening condition associated with a high risk of death within 30 days of enrolment, as determined by the study clinician.\n* Severe acute malnutrition with complications.\n* Severe neurological illness.\n* Hemodynamically significant severe congenital heart disease.\n* Active malignancies.\n* Life-threatening bleeding disorder.\n* Use of systemic immunosuppressive drugs within 30 days before first IMP administration. Not exclusionary: nasal steroid spray, inhaled steroids, topical steroids, a single course of oral\u002Fparenteral prednisone or equivalent at 2 mg\u002Fkg\u002Fday, and length of therapy \\\u003C14 days.\n* Unwillingness to have blood drawn\n* Unable to receive SC medications.\n* Chronic or recurrent urticaria or any other chronic dermatological condition that may be confused with local Adverse Reactions (ARs).\n\nAny social or medical condition in the caregivers that, in the judgement of the investigator, would interfere with protocol adherence, completion of the trial or assessment of safety.","1 Day","1 Year",{"count":84,"type":22},73,[25,86],"PHASE2","The goal of this clinical trial is to learn if subcutaneous ePGT121v1-LS and VRC07-523-LS added to standard antiretroviral therapy (ART) is safe and helps improve HIV viral suppression in infants living with HIV in Mozambique and Cameroon. The study will also learn how the body processes ePGT121v1-LS and VRC07-523-LS and whether caregivers and health workers find this treatment approach acceptable.\n\nThe main questions it aims to answer are:\n\n* Are ePGT121v1-LS and and VRC07-523-LS safe and well tolerated in infants living with HIV?\n* Does adding ePGT121v1-LS and VRC07-523-LS to standard ART increase the number of infants who achieve HIV viral suppression by week 48?\n* How long does it take participants receiving ePGT121v1-LS and VRC07-523-LS to achieve viral suppression compared with standard treatment alone?\n* How does ePGT121v1-LS and VRC07-523-LS behave in the body after repeated subcutaneous injections?\n\nResearchers will compare infants receiving ePGT121v1-LS and VRC07-523-LS plus ART to infants receiving standard ART plus placebo (saline) to see if ePGT121v1-LS improves HIV viral suppression.\n\nParticipants will:\n\n* Continue taking standard oral ART.\n* Receive 4 subcutaneous injections of ePGT121v1-LS and VRC07-523-LS or placebo every 12 weeks.\n* Attend regular clinic visits for safety checks, blood tests, and HIV viral load monitoring.\n* Have follow-up visits for 48 weeks.\n* Participate in evaluations of treatment adherence and acceptability from the perspective of caregivers and health workers.",[28],[90,91,92,93,94,95,96,97],"HIV","broadly neutralizing antibody","ePGT121v1-LS","viral load","safety","infant","children","VRC07-523-LS","2026-06-12",{"date":100,"type":38},"2026-06-17",{"date":102,"type":22},"2027-01-01",{"date":104,"type":22},"2029-12-31",{"name":106,"class":107},"Hospital Universitario 12 de Octubre","OTHER",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":81,"maxAge":82,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":120,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":123,"leadSponsor":124,"locationsCount":4},"100641640","phase-1-early-neutralizing-antibodies-in-infants-living-with-hiv-to-enhance-their-life-100641640","NCT07655128","Early Neutralizing Antibodies in Infants Living With HIV to Enhance Their Life","A Phase 1\u002F2 Trial Evaluating the Safety, Pharmacokinetics, and Antiviral Activity of Subcutaneous ePGT121v1-LS, Added to Standard Antiretroviral Therapy in Infants Living With HIV","ENABLE 1",{"count":116,"type":22},87,[25,86],"The goal of this clinical trial is to learn if subcutaneous ePGT121v1-LS added to standard antiretroviral therapy (ART) is safe and helps improve HIV viral suppression in infants living with HIV in South Africa. The study will also learn how the body processes ePGT121v1-LS and whether caregivers and health workers find this treatment approach acceptable.\n\nThe main questions it aims to answer are:\n\n* Is ePGT121v1-LS safe and well tolerated in infants living with HIV?\n* Does adding ePGT121v1-LS to standard ART increase the number of infants who achieve HIV viral suppression by week 48?\n* How long does it take participants receiving ePGT121v1-LS to achieve viral suppression compared with standard treatment alone?\n* How does ePGT121v1-LS behave in the body after repeated subcutaneous injections?\n\nResearchers will compare infants receiving ePGT121v1-LS plus ART to infants receiving standard ART plus placebo (saline) to see if ePGT121v1-LS improves HIV viral suppression.\n\nParticipants will:\n\n* Continue taking standard oral ART.\n* Receive 4 subcutaneous injections of ePGT121v1-LS or placebo every 12 weeks.\n* Attend regular clinic visits for safety checks, blood tests, and HIV viral load monitoring.\n* Have follow-up visits for 48 weeks.\n* Participate in evaluations of treatment adherence and acceptability from the perspective of caregivers and health workers.",[28],[90,91,92,93,94,95,96],{"date":100,"type":38},{"date":102,"type":22},{"date":104,"type":22},{"name":106,"class":107},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":135,"conditions":136,"keywords":139,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":151,"locationsCount":153},"100642411","impacts-of-hiv-treatment-regimens-on-archived-drug-resistance-100642411","NCT07643948","Impacts of HIV Treatment Regimens on Archived Drug Resistance","Impact of Antiretroviral Therapy (ART) Switch on Archived HIV-1 Drug Resistance in Virally Suppressed Patients: A Prospective Cohort Study","Inclusion Criteria:\n\n* Patients living with HIV who are (a) aged 18 or above, (b) on antiretroviral therapy, (c) has viral load \\\u003C20 copies\u002FmL at 2 time points for ≥6 months, (d) planning regimen switch.\n* Patients for inclusion in the control group meet the same criteria (a) but they are not planned for switch. Controls include patients with low level viremia (LLV) as defined as ≥2 consecutive viral load level between 21 and 200 copies\u002FmL in the preceding 2 years.\n\nExclusion Criteria:\n\n* Patients living with HIV who (a) are pregnant, (b) have virologic failure, (c) are suffering from concurrent opportunistic infections, (d) are prisoners , (e) are unable to give consent, and (f) have mental illnesses.",{"count":133,"type":22},420,"OBSERVATIONAL","The study aims to determine the prevalence of drug resistance mutation (DRM) in virally suppressed HIV infection, and the impacts of regimen change and the presence of low level viremia. Adults living with HIV infection on antiretroviral therapy (ART) with full viral suppression would be recruited. Cases are patients planning for regimen switch, while controls are those with and without low level viraemia (LLV) not planned for switch. Blood samples would be collected before and after switch. Sequencing would be performed to identify DRM present in HIV-1 proviral DNA.",[28,137,138],"Antiretroviral Therapy","Drug Resistance, Microbial",[140,141,142,143,144,145],"antiretroviral therapy","regimen switch","archived resistance","low level viremia","proviral DNA","HIV infection","2026-06-10",{"date":98,"type":38},{"date":149,"type":38},"2025-10-01",{"date":104,"type":22},{"name":152,"class":107},"Chinese University of Hong Kong",1,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":162,"minAge":18,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":165,"conditions":166,"keywords":167,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":179},"100642793","cabotegravir--rilpivirine-antiretroviral-therapy-in-pregnancy-100642793","NCT07637942","Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy","Phase IV Study of the Pharmacokinetics of Long-Acting Injectable Cabotegravir and Rilpivirine in Pregnant and Postpartum Women With HIV in the United States","CREATE","Inclusion Criteria:\n\n* Willing and able to provide written informed consent for study participation for self and infant\n* At screening, age 18 years or older\n* Has a viable, intrauterine, singleton pregnancy with fetal ultrasound with an estimated gestational age (EGA) between 10 0\u002F7 and 23 6\u002F7 weeks (inclusive) at entry\n* At entry, intending to deliver at a study-associated medical facility and remain in the geographic area of the study for the duration of anticipated follow-up\n* Was diagnosed with HIV prior to the current pregnancy\n* Has a documented plasma HIV RNA result less than 50 copies\u002FmL from a specimen collected within 28 days prior to entry\n* Has the following laboratory test results from a specimen collected within 28 days prior to entry (1) Grade 2 or lower platelets (greater than or equal to 50,000 cells\u002Fmm3 or greater than or equal to 50.00 x 109 cells\u002FL); (2) Grade 1 or lower ALT (less than 2.5 x upper limit of normal; (3) Grade 1 or lower aspartate aminotransferase (AST)\n* Received first dose of CAB LA + RPV LA prior to entry (before or after conception of the current pregnancy) and is expected to receive CAB LA + RPV LA on a Q4W schedule for the duration of study participation\n\nExclusion Criteria:\n\n* History of treatment\u002Fvirologic failure associated with documented or suspected viral resistance to CAB or RPV (including oral RPV)\n* Has any of the following (1) HIV Subtype A6; (2) History of hypersensitivity reaction (HSR), known or suspected allergy to drugs under study, or any other contraindication to CAB or RPV; (3) Current contraindication to IM injection such as a current inflammatory skin condition that compromises the safety of IM injections or a dermatological condition which may interfere with the interpretation of ISRs; (4) Current use or anticipated need of therapeutic anticoagulation; (5) History of known or suspected bleeding disorder; (6) Current severe hepatic impairment (Class C) as determined by Child-Pugh classification; (7) History of suicidal ideation or attempt within six months of entry; (8) History of unstable or poorly controlled seizure disorder; (9) Current tuberculosis infection; (10) Current cervical intraepithelial neoplasia (CIN) 2 or 3, or malignancy other than Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma\n* Has any of the following during the current pregnancy: (1) Abnormal placentation, including placenta previa (complete) and placenta accreta\u002Fincreta\u002Fpercreta; (2) Cervical cerclage\u002Fcervical incompetence; (3) Abnormal fetal anatomy\n* Had any of the following in a previous pregnancy: (1) Eclampsia\u002FHemolysis, Elevated Liver enzymes and Low Platelets (HELLP) syndrome; (2) Intrauterine fetal demise (EGA greater than 20 weeks) without known nonrecurrent etiology; (3) Spontaneous very preterm delivery (less than 32 weeks); (4) Very LBW (less than 1500 g); (5) Cervical or abdominal cerclage due to cervical incompetence\n* Receipt of any prohibited medication within seven days prior to entry\n* Enrolled in another clinical trial of an investigational agent, device, or vaccine that may impact the PK of CAB or RPV\n* Receipt of an investigational agent or chemotherapy within 30 days prior to study entry\n* Adult-participant or fetus has any condition, such as uncontrolled diabetes, hypertension, or other comorbidities, that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives","FEMALE",{"count":164,"type":22},40,"Phase IV, multi-site, open-label, non-randomized study of the pharmacokinetics (PK) of long-acting injectable cabotegravir and rilpivirine (CAB LA + RPV LA) during pregnancy and postpartum.",[28],[90,168,169],"Pregnancy","CAB LA + RPV LA","2026-06-09",{"date":146,"type":38},{"date":173,"type":22},"2026-07-15",{"date":175,"type":22},"2028-02-15",{"name":177,"class":178},"International Maternal Pediatric Adolescent AIDS Clinical Trials Group","NETWORK",10,{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":186,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":23,"phases":190,"briefSummary":192,"conditions":193,"keywords":195,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":153},"100637462","integrating-isyv-within-hiv-clinical-care-for-youth-living-with-hiv-in-tanzania-100637462","NCT07621510","Integrating iSYV Within HIV Clinical Care for Youth Living With HIV in Tanzania","Inclusion Criteria:\n\n1. youth living with HIV (YLWH) 15-24 years;\n2. have understanding of their HIV status;\n3. able to attend iSYV sessions if site is randomized to the intervention.\n\nExclusion Criteria:\n\n1. inability to provide informed consent\u002Fassent or participate meaningfully in the intervention due to cognitive impairment, psychosis, or other disability;\n2. enrollment in any other MH, stigma-related, or adherence intervention research study.","15 Years","24 Years",{"count":189,"type":22},5000,[191],"NA","Youth living with HIV (YLWH) experience mental health (MH) challenges that compromise their HIV care. Though the MH gap is well described, MH service delivery to YLWH is rare, especially in low resource settings. MH professionals are few and interventions tailored to the needs of this population are scarce. This project proposes a way to bridge the gap by streamlining the Sauti ya Vijana (SYV, The Voice of Youth) intervention redesigned to integrate into the differentiated HIV clinical care model in Tanzania. SYV is a peer-led, group-based treatment designed with and for YLWH to address their self-reported MH challenges and stressors living with HIV.",[28,194],"Mental Health Issue",[196,197,198,199],"Youth","Adolescents","Tanzania","Cognitive behavioral therapy","2026-05-27",{"date":202,"type":38},"2026-06-02",{"date":204,"type":22},"2027-01-10",{"date":206,"type":22},"2030-09-30",{"name":208,"class":107},"Duke University",{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":217,"targetDuration":4,"studyType":23,"phases":219,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":153},"100639794","phase-4-short-term-effects-of-methamphetamine-on-residual-latent-hiv-disease-study-100639794","NCT07584369","Short-term Effects of Methamphetamine on Residual Latent HIV Disease Study","Short-term Effects of Methamphetamine on Residual Latent HIV Disease (EMRLHD) Study","EMRLHD","Inclusion Criteria:\n\n* Willing and able to provide written informed consent\n* Any gender, age ≥ 18 years \\\u003C 65 years\n* Laboratory confirmed documentation of HIV-1 infection.\n* Continuous therapy with a Department of Health and Human Services (DHHS) recommended\u002Falternative combination ART for least 12 months (at least 3 agents) at study entry with no regimen changes in the preceding 12 weeks\n* Maintenance of undetectable plasma HIV-1 RNA ( \\\u003C40copies\u002Fml) below the limit of quantification for at least 12 months. Episodes of single HIV plasma RNA 50-500 copies\u002Fml will not exclude participation if subsequent HIV plasma RNA is below the limit of assay detection\n* No plans to modify ART during the study period (approximately 4-5 months)\n* Participant and partner(s) are willing to use two forms of contraception throughout the study period as well as up to 60 days after the last day of study completion\n* Ability and availability to participate in the full duration of the study (approximately 4-5 months) and maintain the inclusion\u002Fexclusion criteria\n* No current or prior history of methamphetamine (MA) use disorder by DSM-5 diagnostic criteria. Participants may have a prior history of taking prescription medications containing amphetamines- type stimulants such as Adderall® or Dexedrine® or Ritalin for the treatment of conditions such as attention deficit hyperactivity disorder as long as the participant has not taken these medications in the last 12 months or plans to take these medications during the entire study period\n\nExclusion Criteria:\n\n* History of methamphetamine (\"meth\") use disorder by DSM-5 diagnostic criteria using the 11-symptom checklist.\n* Evidence of MA use other than due to the administered oral methamphetamine study drug, based on urine, hair, or serum MA measurements collected at baseline and follow-up study visits.\n* Current use of prescription medications containing amphetamine-type stimulants (e. g.,Adderall®, Dexedrine®, Ritalin, etc.) within the past 1 year.\n* Sensitivity or allergy to amphetamine-type stimulants.\n* Current use of any other \"psychoactive\" drug within the last 1 month. These include cocaine, ecstasy, lysergic acid diethylamide (LSD), mushrooms, or other recreational drugs - but cannabis, nicotine or caffeine use is ok.\n* Use of illicit opioids (heroin, fentanyl)- but ok if use of prescription opioid agonists with known prescribed doses, such as methadone, hydrocodone (Norco®), buprenorphine\u002Fnaloxone (Suboxone®), oxycodone (Oxycontin®), hydromorphone (Dilaudid®) within the past 3 months by self-report and\u002For urine qualitative screening.\n* Current moderate to severe use of alcohol use disorder (DSM-5 criteria) as this might put patient at risk of withdrawal during the study.\n* Recent use within the last month of the following medications given potential interactions with oral methamphetamine: acebrophylline, iobenguane, isocarboxazid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine, asunaprevir, bupropion, topical cocaine, fluoxetine, iohexol, linezolid, paroxetine, potassium citrate, quinidine, sodium bicarbonate, sodium citrate, sodium lactate, tipranavir, and tromethamine.\n* Recent hospitalization in the last 90 days.\n* Recent infection in the last 90 days requiring prolonged (e.g., \\>3 weeks) of systemic intravenous antibiotics.\n* Known anemia (HIV+ males Hct\\\u003C 34; females Hct\\\u003C 32) or contraindication to donating blood.\n* Screening hemoglobin below 12.5 g\u002FdL\n* Poorly controlled hypertension or systolic blood pressure \\> 140 on repeat measurement in the last 3 months, on more than one occasion.\n* Significant myocardial disease (e.g., current myocarditis or reduced left ventricular ejection fraction below the lower limit of normal) or diagnosed coronary artery disease.\n* History of cardiac arrhythmia that needs to be medically treated.\n* History of psychotic symptoms (e.g., hallucinations, delusional thinking) in the prior 3 months.\n* History of seizures, abnormal electroencephalogram or brain damage with significant persisting neurological deficit in the past 3 months or currently on anti- seizure medications\n* Significant respiratory disease requiring oxygen.\n* Exposure to any immunomodulatory drug (including maraviroc) in the 12 weeks prior to study\n* Prior or current use of experimental agents used with the intent to perturb the HIV-1 viral reservoir in the 12 weeks prior to study.\n* Participants of reproductive potential or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test at screening. All participants of childbearing potential must agree to use a double-barrier method of contraception throughout the study period and up to 90 days after the last dose of MA.\n* Pregnancy. A serum pregnancy test will be performed. If this test is positive, the participant will not be allowed to enter the study since body changes occurring during pregnancy will alter the study results.\n* Recent vaccination within the last 2 weeks prior to study baseline visit.\\* \\*Note: Routine or standard of care vaccinations (such as SARS-CoV-2, influenza, pneumococcal, and meningococcal vaccinations) are allowed, but must be administered greater than 14 days prior to baseline study visit. For SARS-CoV-2 vaccination, the last dose must be administered at least 14 days prior to baseline study visit.",{"count":218,"type":22},20,[220],"PHASE4","The most commonly used illicit stimulant in people with HIV (PWH) is methamphetamine (MA). Prior studies demonstrate strong evidence that MA promotes increased HIV transcription as well as immune dysregulation. A challenge in achieving worldwide HIV eradication is targeting specific marginalized populations who are most likely to benefit from an HIV cure but possess poorer immune responses. For this study, N = \\~20 PWH virally-suppressed on antiretroviral therapy (ART) with no prior history of MA use disorder will be administered oral methamphetamine to determine the effects of short-term MA exposure on residual virus production, gene expression, and inflammation. Measures of MA exposure in urine and serum will then be associated with residual virus production, gene expression, cell surface immune marker protein expression, and systemic markers of inflammation. Thus, the proposed work will leverage a unique clinical trial design to generate advanced gene expression and immunologic data to identify potential novel targets for reversing HIV latency, reducing inflammation, and personalizing future therapies in PWH who use MA.",[28,223],"Methamphetamine Use","2026-05-07",{"date":226,"type":38},"2026-05-13",{"date":228,"type":22},"2026-07-01",{"date":230,"type":22},"2030-05",{"name":232,"class":107},"University of California, San Francisco",{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":23,"phases":243,"briefSummary":244,"conditions":245,"keywords":248,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":179},"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":242,"type":22},200,[220],"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.",[28,246,90,247],"HIV (Human Immunodeficiency Virus)","HIV 1 Infection",[60,249,250,251,252,137,253,254,255,256,257,258,259,260,261],"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":264,"type":38},"2026-03-31",{"date":266,"type":22},"2026-03-23",{"date":268,"type":22},"2026-10-23",{"name":270,"class":107},"CAN Community Health",{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":16,"sex":162,"minAge":18,"maxAge":278,"enrollmentInfo":279,"targetDuration":4,"studyType":23,"phases":281,"briefSummary":282,"conditions":283,"keywords":284,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":153},"100606894","phase-1-safety-study-of-mucocept-cvn-100606894","NCT07181486","Safety Study of MucoCept-CVN","Phase 1 Randomized Double-Blind Placebo-Controlled Safety Study of MucoCept-CVN (Lactobacillus Jensenii 1153-1666) Administered Vaginally to Healthy Women","Inclusion Criteria:\n\n1. Healthy pre-menopausal women 18-45 years of age, inclusive, with regular predictable menstrual cycles\n2. Ability to read and consent in English\n3. Previous experience of gynecological examinations\n4. Consent to participate and adhere to all procedures, including frequent visits at the UCSF Clinical Research Center (CRC) facility for at least 53 days\n5. Agree to get tested for STIs and a Pap Smear\n6. Agree not to use any other vaginal product during the course of the study, including spermicides\n7. Agree to sexual abstinence (no vaginal, anal, and receptive oral intercourse) until the elimination of L. jensenii 1153-1666 is confirmed and for 12 hours prior to the final study visit after clearance is confirmed\n8. For participants with male sexual partners: Agree to use two forms of contraception, condoms plus hormonal or permanent method (intrauterine device \\[IUD\\] or tubal ligation) during vaginal intercourse from the time clearance is established to the Final Visit 30 days after clearance. Use of spermicides is not permitted.\n9. For participants with female sexual partners: Agree to use female condoms during intercourse from the time clearance is established to the Final Visit 30 days after clearance. Use of hormonal or permanent method of contraception (IUD or tubal ligation) is not required.\n10. Agree to inform their sexual partner about the goals of the study and importance of sexual abstinence (no vaginal, anal, and receptive oral intercourse) and present with their partner at enrollment visit for separate consent procedure for partners\n\nCurrent sexual partners of participants must meet all the following criteria to be enrolled:\n\n1. Ability to read and consent in English\n2. Consent to participate and adhere to all procedures for sexual partners should exposure to L. jensenii 1153-1666 be suspected, including multiple visits at the UCSF Clinical Research Center (CRC)\n3. Agree to sexual abstinence (no vaginal, anal, and receptive oral intercourse) until the elimination of L. jensenii 1153-1666 is confirmed, and for 12 hours prior to the final study visit after clearance is confirmed\n\nExclusion Criteria:\n\n1. Urogenital infection, including UTI, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Treponema pallidum, HIV-1\u002F2, BV, or vulvovaginal candidiasis\n2. Abnormal Pap smear result\n3. Pregnancy or within two months of last pregnancy or lactation\n4. Antibiotic or antifungal therapy (vaginal or systemic) within 30 days of enrollment\n5. Investigational or immune-suppressive drug use within 30 days of enrollment visit or 10 half-lives, or planned during the study\n6. Intrauterine device insertion or removal, pelvic surgery, cervical cryotherapy, cervical laser or loop electrosurgical procedure, abortion, labioplasty within three months prior to enrollment\n7. Findings during the pelvic exam at the enrollment visit involving significant deep disruption of the epithelium (e.g., Herpes genitalis lesions)\n8. Known allergy to any component used in MucoCept-CVN or clindamycin and azithromycin in participant or sexual partner(s), including azithromycin-associated cholestatic jaundice.\n9. History of transplant surgery, cancer, HIV, diabetes or condition that could facilitate the growth of microorganisms\n10. Recent history of drug or alcohol abuse\n11. Unwillingness to abstain from sexual activity during study by participant or sexual partner(s)\n12. If in a sexual relationship, inability to present with their sexual partner before enrollment\n13. If in a sexual relationship, having multiple concurrent partners or anonymous partners.\n14. Any other condition which the study clinician feels would limit the participant's ability to be an appropriate study subject\n15. History of regional enteritis (Crohn's disease), ulcerative colitis, or \"antibiotic-associated\" colitis\n\nFor sexual partners of study participants, the following exclusion criteria apply:\n\n1. Known allergy to any component used in MucoCept-CVN or clindamycin and azithromycin, including azithromycin-associated cholestatic jaundice.\n2. Having multiple concurrent sex partners or anonymous sex partners.\n3. HIV-1\u002F2 infection\n4. Any other condition which the study clinician feels would limit the ability of sexual partner(s) to complete the study\n5. Co-enrollment in clinical trials testing study drugs","45 Years",{"count":280,"type":22},12,[25],"MucoCept-CVN uses a Lactobacillus strain native to the human vagina that is modified into a live biotherapeutic product (LBP) that continuously expresses a potent anti-HIV drug. If research shows that MucoCept-CVN is safe and effective, it could become a self-renewing, female-initiated prevention product for women that promotes vaginal health and provides protection from HIV.\n\nThe goal of this first-in-human Phase 1 dose-ranging, randomized, placebo-controlled study of MucoCept-CVN is to collect data on safety, colonization, changes to the vaginal microbiota and clearance of the strain with antibiotics.\n\nTwelve healthy women will be enrolled and take either one or three doses of MucoCept-CVN or placebo, and a week later will receive antibiotics to clear the Lactobacillus strain.\n\nIf research shows that MucoCept-CVN is safe and effective, it could become a self-renewing, long-acting, female-initiated prevention product for women that promotes vaginal health and provides protection from HIV.",[28],[285,286,287,288],"HIV prevention","live biotherapeutic product","MucoCept-CVN","Vaginal microbiome","2026-01-30",{"date":291,"type":38},"2026-02-03",{"date":293,"type":38},"2025-10-06",{"date":295,"type":22},"2027-10-31",{"name":297,"class":107},"Craig Cohen, MD, MPH",{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":23,"phases":308,"briefSummary":309,"conditions":310,"keywords":311,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":326},"100622515","phase-1-combining-latency-reversing-agents-to-address-the-hiv-reservoir-100622515","NCT07384624","Combining Latency Reversing Agents to Address the HIV Reservoir","Curing HIV: Proof of Concept Randomized Clinical Trial With Pyrimethamine, Lenalidomide, TOpiramate","PLUTO","Inclusion Criteria:\n\n* Documented HIV-1 infection, confirmed by 4th generation ELISA, Western Blot or PCR.\n* Age ≥ 18 years old.\n* Confirmed HIV1, subtype A, B, C or D.\n* Uninterrupted ART therapy for a minimum 6 months. .\n* Plasma HIV RNA \\\u003C≤50 copies\u002Fml prior to inclusion at two consecutive measurements at least three months apart.\n* No disclosed missed ART on more than 2 days per month.\n* Current blood CD4+T-cell count of ≥200 cells\u002Fmm3\n* No clinical signs of cellular immunodeficiency or AIDS.\n* Pre-ART plasma HIV RNA ≥1000 copies\u002FmL.\n* Able to understand provided information and to give informed consent.\n\nExclusion Criteria:\n\n* Prior exposure to any of the studied LRAs in the previous 90 days\n* HIV-2 (double)infection\n* Co-infection with hepatitis B, unless resolved HBV (anti-HBc positive, anti-HBs positive and HBsAg negative) OR HBsAg positive and on continuous HBV-active antiviral therapy for ≥24 weeks prior to dosing, and HBV DNA undetectable or ≤ 200 IU\u002FmL on two measurements (screening and within 4 weeks prior to enrolment), and no history of advanced fibrosis\u002Fcirrhosis (stage F2 and higher)\n* Co-infection with hepatitis C, measured by the presence of hepatitis C virus RNA in blood.\n* Co-medication with clinically significant interactions with LRA\n* mRNA vaccine or adjuvant vaccine (e.g. Shingrix) in the previous 8 weeks.\n* Megaloblastic anaemia due to folate deficiency and untreated haemolysis of any cause\n* Active malignancy during the past year with the exception of basal carcinoma of the skin, stage 0 cervical carcinoma, Kaposi's sarcoma treated with ART alone or other indolent malignancies.\n* History of suicide attempt or suicidal ideation.\n* History of ophthalmological medical problems leading to glaucoma or visual field disturbances (e.g. macula oedema). Refraction abnormalities that can be corrected by lenses are acceptable.\n* History of any medical condition with a causal relationship with hyperammonemia.\n* History of epileptic seizures in the previous year.\n* Registered allergies for any of the investigational medical products\n* Sexually active participants who do not fit any of the following:\n\n  a) Female subject of childbearing potential willing to comply with pregnancy tests before start and four weeks after end of treatment and willing to use of double contraceptive measures during and until 1 week after administration of study medication. Non-childbearing is defined by one of the following criteria: amenorrhoea for ≥ 1 year, premature ovarian failure, assigned male at birth, or having undergone bilateral salpingo-oophorectomy, or hysterectomy. b) Sexually active male PLWH who have sex with female partners of childbearing potential and willing to abstain from sex or willing to use condom protection during and until 1 week after administration of study medication.\n\n  c) Sexually active male PLWH who have sex with postmenopausal female partners and willing to abstain from sex or willing to use condom protection or with a postmenopausal female partner on pre-exposure prophylaxis during and until 1 week after administration of study medication.\n\n  d) Male PLWH who have sex with male partners and willing to abstain from sex or willing to use a condom protection during and until 1 week after administration of study medication.\n\n  e) Male PLWH who have sex with male partners on preexposure prophylaxis during and until 1 week after administration of study medication.\n* Any lab abnormalities at screening as listed below:\n\n  1. Moderate kidney impairment, defined as eGFR \\\u003C50 mL\u002Fmin. In PLWH on dolutegravir- or bictegravir-based ART regimens, cystatin C-based eGFR can be used, since possible drug interference with tubular creatinine excretion which leads to eGFR underestimation.\n  2. Moderate hepatic impairment, defined as bilirubin \\> 3 x upper limit of normal (ULN) or ALT \\> 3x ULN\n  3. Inadequate blood counts, defined as: haemoglobin \\\u003C6.5 mmol\u002FL (males) or \\\u003C6.0 mmol\u002FL (females), Absolute neutrophil count \\\u003C1000 cells\u002Fmm3, thrombocytes \\\u003C100 x109\u002FL, international standardized ratio \\>1.6, activated partial thromboplastin time \\>40 seconds,",{"count":307,"type":22},30,[25,86],"The PLUTO trial aims to contribute to the worldwide search for a functional cure of HIV. One the strategies (\"shock and kill' strategy) aims to reverse the HIV-reservoir from latency by increasing cell-associated HIV-RNA, which will lead to increased antigen presentation, trigger immune recognition, and facilitate the elimination of reservoir cells. Participants of the trial are adults with HIV with undetectable viral load that are able to give informed consent to participate in the trial, in total 30 patients will be recruited. The investigational medical compounds in this trial are topiramate, lenalidomide and pyrimethamine, which will be combined. These are all licensed drugs for other conditions.\n\nThe study consists of two phases. In phase I participants will receive a single dose of the IMPs, as combination therapy. Sampling will be performed before, during and after medical treatment to evaluate latency reversal and safety endpoints. In phase II, participants will receive the combination of IMPs which is the most potent and within safety limits selected from phase I during a four-week treatment. Sampling will take place on a weekly basis to assess latency reversal, reservoir reduction and safety.\n\nParticipants will be recruited from the Erasmus MC, Amsterdam university Medical Center, Radboud University Medical Center and the University Medical Center Utrecht.",[246,28],[90,312,313,314,315,316,317],"HIV reservoir","Latency Reversing Agent","HIV cure","Topiramate","Pyrimethamine","Lenalidomide","2026-01-29",{"date":291,"type":38},{"date":321,"type":22},"2026-04",{"date":323,"type":22},"2028-07",{"name":325,"class":107},"Erasmus Medical Center",4,{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":336,"conditions":337,"keywords":342,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":352},"100607260","prevention-icona-dedicated-ensemble-100607260","NCT07186244","Prevention ICONA Dedicated Ensemble","Implementation of an Italian Cohort of People on HIV-1 Pre-exposure Prophylaxis Within the ICONA Network: PrIDE (Prevention ICONA Dedicated Ensemble)","PrIDE","Inclusion Criteria:\n\n* Age \\>18 years\n* Negative HIV Ab\u002FAg test (4th generation or higher) at the enrollment visit\n* Request and\u002For willingness to take PrEP, or already on PrEP\n* Ability to understand the study procedures and to sign informed consent\n\nExclusion Criteria:\n\n* Individuals with HIV infection or with strong clinical\u002Fepidemiological suspicion of HIV infection\n* Individuals with contraindications to the use of medications included in the PrEP regimen (as per the product information)\n* Documented allergy to one or more pharmacological components of the proposed PrEP regimen\n* Lack of willingness to adhere to the required procedures and follow-up assessments",{"count":189,"type":22},"Despite significant advances in HIV treatment, transmission remains a public health concern. In 2022, there were 1.3 million new HIV infections worldwide and 1,888 new diagnoses in Italy, with sexual transmission being the predominant route. Many individuals are still diagnosed late, and a portion of people living with HIV are unaware of their status. Pre-Exposure Prophylaxis (PrEP) has emerged as an effective biomedical strategy to prevent new infections, especially when integrated into comprehensive prevention efforts.\n\nStudy Objectives The primary objective of this observational study is to establish a large prospective cohort of individuals using PrEP in Italy. The study aims to assess PrEP's effectiveness, tolerability, adherence, and barriers to long-term use in a real-world setting. These data will be instrumental in guiding future strategic interventions to optimize PrEP management and move toward the goal of zero new HIV infections in Italy.\n\nPrimary Objective\n\n* To assess the incidence of new HIV infections among PrEP users in Italy. Secondary Objectives\n* Incidence of other sexually transmitted infections (STIs);\n* Tolerability of PrEP;\n* Psychological and behavioral aspects related to PrEP use;\n* Adherence and persistence in care;\n* Use of therapies and prophylaxis for STIs during PrEP use. Study Design and Coordination This is a prospective observational study, promoted by Fondazione ICONA in collaboration with clinical centers and community-based organizations. The coordinating enrolling center is INMI \"L. Spallanzani\" IRCCS in Rome.\n\nParticipating Centers:\n\n* 49 university and hospital-based centers across Italy;\n* 4 non-clinical checkpoints offering PrEP screening, prescription, and follow-up.\n\nStudy Population Adults (≥18 years) who are HIV-negative, sexually active, and considered eligible for PrEP per national or international guidelines, including both new and current PrEP users.\n\nInclusion Criteria\n\n* Age ≥18 years;\n* Negative HIV test at enrollment;\n* Willingness to initiate or continue PrEP;\n* Informed consent provided. Exclusion Criteria\n* HIV infection or strong suspicion of infection;\n* Contraindications to PrEP medications; Known allergy to PrEP components; Refusal to comply with study procedures.",[338,339,90,28,340,341],"PrEP","PrEP Adherence Monitoring","STI","STI Prevention",[338,90,340,341],"2025-09-15",{"date":345,"type":38},"2025-09-22",{"date":347,"type":38},"2024-09-09",{"date":349,"type":22},"2033-12-31",{"name":351,"class":107},"Fondazione ICONA",53,{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":23,"phases":362,"briefSummary":363,"conditions":364,"keywords":366,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":379},"100594564","person-centered-approaches-to-viremia-connection-rapport-and-engagement-study-100594564","NCT07021092","PERSON-CENTERED APPROACHES TO VIREMIA: CONNECTION, RAPPORT, AND ENGAGEMENT STUDY","P-CoRE","Inclusion Criteria:\n\n1. Patients that are lost to follow up (\\[LTFU\\] from HIV care i.e. confirmed \\>30 days late for a scheduled appointment) at the time of sampling. (i.e. not people who were previously LTFU but then returned and have a documented VL.)\n2. Individuals returning to care after being out of care and not taking ART with no VL measure (i.e., unmeasured viremia)\n3. Patients that are 6 months late for a scheduled Viral Load (VL) according to Ministry of Health guidelines at the time of sampling (regardless of care status)\n4. Patients that have a last documented VL that is elevated, \\> 1000 copies\u002Fml at time of sampling in current clinic population (CCP) (regardless of care status)\n5. Participant that are willing to provide written informed consent in English, or any of the local languages that include Nyanja or Bemba.\n\nExclusion Criteria:\n\n1. Patients that are unable to provide consent or unwilling to participate in the study\n2. Participant who is NOT living with HIV\u002FAIDS;\n3. Participant is too sick i.e., failing to talk, general discomfort and emergency cases);",{"count":361,"type":22},3000,[191],"The study aims to increase the reach of the person-centred interpersonal practices by developing and accessing a tailored, scalable, and sustainable approach that meets the distinctive needs of populations identified as most disproportionately affected by viremia in Zambia. The study population include pregnant and breastfeeding women, children, adolescents and adult that are more than thirty -30 days late for their next hospital appointments.The study will be implemented over a period of 36 months in 24 facilities in Lusaka and Central province, Zambia.",[365,28],"HIV Viremia",[367,368,369],"Uncontrolled Viremia","Person Centred Care","Unmonitored Viral Load","2025-06-12",{"date":372,"type":38},"2025-06-13",{"date":374,"type":38},"2025-04-01",{"date":376,"type":22},"2027-06-30",{"name":378,"class":107},"Centre for Infectious Disease Research in Zambia",2,{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":389,"conditions":390,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":4},"100565102","establishment-of-a-database-of-hiv-subjects-initiating-or-simplifying-dual-therapy-with-dolutegravirlamivudine-100565102","NCT06637813","Establishment of a Database of HIV Subjects Initiating or Simplifying Dual Therapy With Dolutegravir\u002FLamivudine","NEW_ODOACRE","Inclusion Criteria:\n\n* signed informed consent\n* patients treated with triple therapy who simplify to 3TC+DTG\n* patients treatment-naive who start a dual therapy with 3TC+DTG from clinical practice\n\nExclusion Criteria:\n\n* lack of willingness to provide informed consent",{"count":388,"type":22},1220,"The introduction of combination antiretroviral therapy (cART) has completely revolutionized the management of HIV-positive patients, drastically reducing HIV-associated mortality and morbidity. In fact, the course of HIV infection has transformed into a chronic disease. The availability of different classes of antiretroviral drugs, such as nucleoside and non-nucleoside reverse transcriptase inhibitors (NRTIs, NNRTIs), protease inhibitors (PIs), integrase inhibitors (INSTIs) and viral entry inhibitors (IEs) that act in different phases of the HIV life cycle, together with careful patient management, has allowed us to obtain long-lasting therapeutic efficacy in the vast majority of Italian patients, making this infection a chronic disease.",[28],"2024-10-09",{"date":393,"type":38},"2024-10-15",{"date":395,"type":22},"2024-10-30",{"date":397,"type":22},"2034-10-30",{"name":399,"class":107},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS"]