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Lenacapavir Injection

DRUG10 trials

Sponsors

Gilead Sciences, Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida, Desmond Tutu HIV Foundation

Conditions

HIVHIV I InfectionHIV InfectionsHIV Pre-exposure ProphylaxisHIV-1 InfectionHIV-1-infectionPre-Exposure Prophylaxis of HIV Infection

Phase 2

A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
Active, not recruitingNCT05729568
Gilead SciencesHIV-1 Infection
Start: 2023-05-15End: 2030-12-01Updated: 2026-04-27
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)
Active, not recruitingNCT06101342
Gilead SciencesPre-Exposure Prophylaxis of HIV Infection
Start: 2023-12-13End: 2028-01-01Updated: 2026-03-02
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)
Active, not recruitingNCT06101329
Gilead SciencesPre-Exposure Prophylaxis of HIV Infection
Start: 2023-11-17End: 2028-01-31Updated: 2025-09-23
Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)
Active, not recruitingNCT06513312
Gilead SciencesPre-Exposure Prophylaxis of HIV Infection
Start: 2024-10-07End: 2028-11-01Updated: 2026-06-15
A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1
RecruitingNCT07645287
Gilead SciencesHIV-1-infection
Start: 2026-06-15End: 2033-04-01Target: 175Updated: 2026-07-10
Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment
Not yet recruitingNCT07708727
Gilead SciencesHIV-1-infection
Start: 2026-07-01End: 2033-04-01Target: 700Updated: 2026-07-16

Phase 3

Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)
Active, not recruitingNCT07047716
Gilead SciencesHIV Pre-exposure Prophylaxis
Start: 2025-07-22End: 2028-09-01Updated: 2026-06-22

Unknown Phase

Real World Use of Lenacapavir, as an add-on to an Optimized Background Regimen in France
RecruitingNCT06799338
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le SidaHIV I Infection
Start: 2025-03-03End: 2025-12-31Target: 80Updated: 2025-05-22
ALIGN: A Non-randomised Study Delivering Injectable Lenacapavir for HIV Prevention Within a Pre-exposure Prophylaxis (PrEP) Choice Context in Cape Town, South Africa.
Not yet recruitingNCT07390409
Desmond Tutu HIV FoundationHIV
Start: 2026-01-29End: 2028-05-01Target: 3700Updated: 2026-02-05
Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
RecruitingNCT07473778
Gilead SciencesHIV Infections
Start: 2026-03-17End: 2029-04-01Target: 3000Updated: 2026-06-30

Related Papers

Methamphetamine use and HIV prevention: a qualitative study on challenges and opportunities for PrEP utilization.
2026-01-07
P-1248. Phase 2 Pharmacokinetics and Anti-Drug Antibody Results of the Investigational Twice-Yearly HIV-1 Treatment Regimen Lenacapavir, Teropavimab, and Zinlirvimab
Open Forum Infectious Diseases2026-01-01
P-365. Pooled safety and tolerability of twice-yearly lenacapavir with teropavimab and zinlirvimab for HIV-1 treatment
Open Forum Infectious Diseases2026-01-01