7 active not recruiting, 3 recruiting. 10 Phase 3, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 10 | Active not recruiting 7, Recruiting 3 |
| Phase 2 | 4 | Active not recruiting 3, Recruiting 1 |
Follow lenacapavir: new trials by email Literature Review of lenacapavir trials Research Report on lenacapavir
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment GS-3242 Tablet, GS-3242 Injection, Lenacapavir Tablet - HIV-1-infection | Phase 2 / Phase 3 | Recruiting | Gilead Sciences | 700 | 2026-07-29 | 2026-10-13 |
| Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy Lenacapavir, Lenacapavir Tablet, Teropavimab - HIV Infections | Phase 3 | Recruiting | Gilead Sciences | 590 | 2026-07-14 | 2026-08-14 |
| Study of Lenacapavir, Teropavimab, and Zinlirvimab in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment Regimens Lenacapavir, Lenacapavir Tablet, Teropavimab - HIV-1-infection | Phase 3 | Recruiting | Gilead Sciences | 590 | 2026-07-14 | 2026-07-30 |
| Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP) Lenacapavir Injection, Lenacapavir Tablet - HIV Pre-exposure Prophylaxis | Phase 3 | Active not recruiting | Gilead Sciences | 339 | 2025-07-22 | 2026-08-28 |
| Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1 Lenacapavir, Bictegravir/Lenacapavir (BIC/LEN) FDC, Bictegravir/Lenacapavir - HIV-1-infection | Phase 2 / Phase 3 | Active not recruiting | Gilead Sciences | 75 | 2024-11-20 | 2026-09-29 |
| Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy Bictegravir, Lenacapavir, B/F/TAF - HIV-1-infection | Phase 3 | Active not recruiting | Gilead Sciences | 577 | 2024-03-25 | 2026-06-15 |
| Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1) Bictegravir, Lenacapavir, BIC/LEN FDC - HIV-1-infection | Phase 2 / Phase 3 | Active not recruiting | Gilead Sciences | 689 | 2022-08-16 | 2026-10-21 |
| Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection Oral Lenacapavir (LEN), Subcutaneous (SC) Lenacapavir (LEN), F/TAF - Pre-Exposure Prophylaxis of HIV Infection | Phase 3 | Active not recruiting | Gilead Sciences | 5368 | 2021-08-30 | 2026-10-16 |
| Pre-Exposure Prophylaxis Study of Lenacapavir in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People at Risk for HIV Infection Oral Lenacapavir (LEN), F/TDF, Sub-cutaneous (SC) Lenacapavir (LEN) - Pre-Exposure Prophylaxis of HIV Infection | Phase 3 | Active not recruiting | Gilead Sciences | 3292 | 2021-06-28 | 2026-10-06 |
| Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance Oral Lenacapavir, Oral Lenacapavir Placebo, Subcutaneous Lenacapavir - HIV-1-infection | Phase 2 / Phase 3 | Active not recruiting | Gilead Sciences | 72 | 2019-11-21 | 2026-10-01 |
HIV Infections (1)
Gilead Sciences (10)
United States (9) · South Africa (5) · Argentina (4) · Canada (4) · Italy (4) · Japan (4) · Puerto Rico (4) · Spain (4) · Australia (3) · Dominican Republic (3) · Germany (3) · Taiwan (3) · France (2) · Mexico (2) · South Korea (2)
PMID 41313173, PMID 41449429, PMID 41763229, PMID 42105781
2023 (4), 2025 (2), 2019 (1)