8 active not recruiting, 4 recruiting, 1 completed. 13 Phase 2, 4 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 13 | Active not recruiting 8, Recruiting 4, Completed 1 |
| Phase 3 | 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 |
|---|---|---|---|---|---|---|
| Substudy-01: A Study of Long-Acting HIV-1 Treatments Taken by Mouth in People With HIV-1 With Undetectable Virus Levels B/F/TAF, GS-3242, Lenacapavir - HIV-1 Infection | Phase 2 | Recruiting | Gilead Sciences | 125 | 2026-10-01 | 2026-10-23 |
| 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 |
| A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1 GS-3242 Tablet, GS-3242 Injection, Lenacapavir Tablet - HIV-1-infection | Phase 2 | Recruiting | Gilead Sciences | 175 | 2026-06-15 | 2026-10-15 |
| Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children Oral Lenacapavir, Subcutaneous Lenacapavir, Optimized Background Regimen (OBR) - HIV-1-infection | Phase 2 | Recruiting | Gilead Sciences | 12 | 2025-03-26 | 2026-04-24 |
| 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 of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP) Lenacapavir Injection, Lenacapavir Tablet, Emtricitabine/tenofovir disoproxil fumarate (F/TDF) - Pre-Exposure Prophylaxis of HIV Infection | Phase 2 | Active not recruiting | Gilead Sciences | 268 | 2024-10-07 | 2026-06-15 |
| Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103) Lenacapavir Injection, Lenacapavir Tablet, Emtricitabine/tenofovir disoproxil fumarate (F/TDF) - Pre-Exposure Prophylaxis of HIV Infection | Phase 2 | Active not recruiting | Gilead Sciences | 181 | 2023-12-13 | 2026-08-13 |
| Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102) Lenacapavir Tablet, Lenacapavir Injection, Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) - Pre-Exposure Prophylaxis of HIV Infection | Phase 2 | Active not recruiting | Gilead Sciences | 253 | 2023-11-17 | 2026-08-17 |
| A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection Teropavimab, Zinlirvimab, Lenacapavir Tablet - HIV-1 Infection | Phase 2 | Active not recruiting | Gilead Sciences | 83 | 2023-05-15 | 2026-04-27 |
| 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 |
| Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV ISL, LEN, B/F/TAF - HIV-1 Infection | Phase 2 | Active not recruiting | Gilead Sciences | 142 | 2021-10-05 | 2026-02-04 |
| Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With Other Antiretroviral Agents in People Living With HIV Oral Lenacapavir, F/TAF, Subcutaneous Lenacapavir - HIV-1-infection | Phase 2 | Completed | Gilead Sciences | 183 | 2019-11-22 | 2024-10-02 |
| 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 |
Gilead Sciences (13)
United States (12) · Canada (5) · Puerto Rico (5) · South Africa (4) · Australia (3) · Dominican Republic (3) · France (3) · Italy (3) · Spain (3) · Argentina (2) · Germany (2) · Japan (2) · Taiwan (2) · United Kingdom (2) · South Korea (1)
PMID 34358495, PMID 41056006, PMID 41313173, PMID 41429026, PMID 41498432, PMID 41720146, PMID 41763229
2023 (2), 2019 (1)