Lenacapavir (Sunlenca) may appear in treatment-experienced HIV studies or in prevention research. Those are different protocols. HIV status requirements are on the NCT record. Search the same name on ClinicalTrials.gov.
Also tagged in this snapshot for: HIV Treatment · HIV Prevention · HIV-1-infection · HIV I Infection · Human Immunodeficiency Virus · HIV Infections · HIV Pre-exposure Prophylaxis · HIV Prevention Program · HIV Prevention and Care · HIV Pre-exposure Prophylaxis Use · Contact With or Exposure to Human Immunodeficiency Virus · Misinformation
RecruitingNot a traditional drug phaseAurora, Colorado
Not a traditional drug phase: At Home Self-Collections for HIV TreatmentThe goal of this watch-and-measure (no experimental treatment required) study is to establish an operational framework for home self-collections of blood samples to be used for antiviral drug concentration measurements. Participants will continue on their prescribed antiviral(s) for HIV treatment or prevention and followed for up to approximately 1 year.
NCT04979728 · Official ClinicalTrials.gov record · University of Colorado, Denver
RecruitingPhase 2Atlanta, Georgia
Phase 2: testing Oral Lenacapavir for HIV-1-infectionThe goal of this clinical study is to learn more about the study drug, lenacapavir (LEN). The study will assess the safety, tolerability, and how well it works of long-acting LEN when combined with other medicines in adolescents and children living with HIV-1 who weigh at least 35 kg and have been treated before for HIV-1.
NCT06749054 · Official ClinicalTrials.gov record · Gilead Sciences
RecruitingNot a traditional drug phaseParis, Île-de-France Region
Not a traditional drug phase: testing Lenacapavir Injection for HIV I InfectionFor 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.
NCT06799338 · Official ClinicalTrials.gov record · Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
RecruitingPhase 1Bethesda, Maryland
Phase 1: testing Lenacapavir for Human Immunodeficiency VirusBackground: Antiretroviral viral therapy (ART) allows people with human immunodeficiency (HIV) to live long, healthy lives. HIV can remain in the body, in infected cells called reservoirs.
NCT06819176 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)
RecruitingNot a traditional drug phaseNew York, New York
Not a traditional drug phase: TAIL-PrEP for patients discontinuing cab-LA for HIV InfectionsThe goal of the TAIL-PrEP study is to understand how to support the safe discontinuation of injectable long-acting cabotegravir (cab-LA) and lenacapavir (LEN) while maximizing the public health impact of biomedical HIV prevention interventions. In Aim 1, the study will pilot test and assess the acceptability and feasibility of the TAIL-PrEP intervention: for participants discontinuing cab-LA, this will consist of monthly cabotegravir drug level monitoring to provide personalized HIV prevention coaching, for participants considering discontinuing cab-LA or LEN, this will consist of a one-time personalized HIV prevention coaching session.
NCT06868641 · Official ClinicalTrials.gov record · Columbia University
RecruitingPhase 4Durham, North Carolina
Phase 4: testing Lenacapavir long-acting for HIV PreventionThe purpose of this project is to test a culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir) program for Latine gay and bisexual men (GBM) and transgender women (TGW). The objective is to evaluate whether this intervention demonstrates greater persistence on lenacapavir for Latine GBM and TGW compared with what has been observed historically at the Duke PrEP Clinic.
NCT07218211 · Official ClinicalTrials.gov record · Duke University
RecruitingNot a traditional drug phaseBoston, Massachusetts
Not a traditional drug phase: Choice of follow up for HIV Pre-exposure Prophylaxis UsePrEP4U is designed as a pragmatic, randomly assigned implementation trial to test strategies that could directly inform real-world roll-out of lenacapavir. By integrating: * Same-day initiation based on rapid HIV testing, and * Choice of follow-up delivery location (home, community, or clinic) the study addresses two of the most pressing implementation questions for long-acting injectable PrEP.
NCT07335289 · Official ClinicalTrials.gov record · Massachusetts General Hospital
RecruitingNot a traditional drug phaseSanta Monica, California
Not a traditional drug phase: testing Lenacapavir for HIV PreventionThis project evaluates the implementation strategy of the delivery of lenacapavir pre-exposure prophylaxis (LEN PrEP) - a newly available long-acting, injectable medication for human immunodeficiency virus (HIV) prevention - via a mobile health van model for people who are unstably housed in Los Angeles County (LAC). People who are unhoused or are facing housing instability experience significant barriers to accessing HIV prevention care in traditional clinic settings.
NCT07467018 · Official ClinicalTrials.gov record · University of California, Los Angeles
RecruitingNot a traditional drug phaseBirmingham, Alabama
Not a traditional drug phase: testing Lenacapavir Injection for HIV InfectionsThe goal of this watch-and-measure (no experimental treatment required) study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States. The study will characterize how PrEP is initiated, used, and discontinued in routine clinical practice when LEN is added as PrEP option and will evaluate persistence on LEN PrEP.
NCT07473778 · Official ClinicalTrials.gov record · Gilead Sciences
RecruitingNot a traditional drug phaseManaus, Amazonas
Not a traditional drug phase: testing Lenacapavir long-acting for Contact With or Exposure to Human Immunodeficiency VirusThe goal of this study is to learn how well long-acting lenacapavir works to prevent human immunodeficiency virus (HIV) infection in people at higher risk of getting HIV in Brazil. The study will also learn about safety, continued use over time, and whether people prefer this option compared to daily oral pre- exposure prophylaxis (PrEP).
NCT07497594 · Official ClinicalTrials.gov record · Oswaldo Cruz Foundation
RecruitingNot a traditional drug phaseJohannesburg
Not a traditional drug phase: Diabetes information for MisinformationAdolescent girls and young women (AGYW) in South Africa remain disproportionately affected by HIV, with prevalence among 15-24-year-olds at 9.4% in 2024 despite expanded access to condoms, HIV testing, and oral PrEP. While oral PrEP is effective, its reliance on daily adherence and regular follow-up has limited impact for many young women.
NCT07518914 · Official ClinicalTrials.gov record · University of Pennsylvania
RecruitingPhase 2Phoenix, Arizona
Phase 2: testing GS-3242 Tablet for HIV-1-infectionThe study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35.
NCT07645287 · Official ClinicalTrials.gov record · Gilead Sciences
RecruitingPhase 3San Francisco, California
Phase 3: testing Lenacapavir for HIV InfectionsThe goal of this clinical study is to compare how effective a long-acting injectable treatment of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) versus (CAB) and rilpivirine (RPV) injections given every 8 weeks in adults with HIV-1 whose virus is well controlled on daily oral treatment, after 1 year (52 weeks) of the treatment. The primary objective of this study are to measure the how well it works of switching to the regimen of LEN, TAB, and ZAB versus switching to CAB and RPV in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.
NCT07682961 · Official ClinicalTrials.gov record · Gilead Sciences
RecruitingPhase 3Berkeley, Michigan
Phase 3: testing Lenacapavir for HIV-1-infectionThe goal of this clinical study is to compare how effective a long-acting treatment of injectable combination of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) is versus continuing a daily oral HIV treatment in adults with HIV-1 whose virus is already well controlled, after 1 year (52 weeks) of treatment. The primary objective of this study is to measure the how well it works of switching to the regimen of LEN, TAB, and ZAB versus continuing an oral stable baseline regimen (SBR) in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.
NCT07683000 · Official ClinicalTrials.gov record · Gilead Sciences
RecruitingPhase 2 / Phase 3Torrance, California
Phase 2 / Phase 3: testing GS-3242 Tablet for HIV-1-infectionThe study will have two portions: Phase 2 and Phase 3. Phase 2 will further have 2 parts: Part A and Part B.
NCT07708727 · Official ClinicalTrials.gov record · Gilead Sciences
RecruitingPhase 2Ft. Pierce, Florida
Phase 2: testing B/F/TAF for HIV-1 InfectionMaster Protocol: The main goal of this master clinical study is to measure the safety, tolerability, how well it works, and pharmacokinetic (PK) of long-acting oral (LAO) regimens in people with HIV-1 (PWH). The main goal of this Substudy-01 is to assess the safety, tolerability, effectiveness, and PK of switching to weekly LAO regimens, including GS-3242 + LEN, versus continuing on once daily oral bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; coformulated; Biktarvy®) in PWH with controlled HIV infection, B/F/TAF for at least 6 months prior to study start.
NCT07841990 · Official ClinicalTrials.gov record · Gilead Sciences