12 active not recruiting, 11 recruiting, 3 completed, 1 not yet recruiting. 13 Phase 2, 10 Phase 3, 3 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 13 | Active not recruiting 8, Recruiting 4, Completed 1 |
| Phase 3 | 10 | Active not recruiting 7, Recruiting 3 |
| Phase 1 | 3 | Completed 2, Recruiting 1 |
| Phase 4 | 1 | 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 |
| 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 |
| 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 |
| Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County Community-based healthcare delivery, Lenacapavir - HIV Prevention | Recruiting | University of California, Los Angeles | 100 | 2026-04-21 | 2026-04-23 | |
| Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention Lenacapavir Injection, Emtricitabine/tenofovir disoproxil fumarate (F/TDF), Emtricitabine/tenofovir alafenamide (F/TAF) - HIV Infections | Recruiting | Gilead Sciences | 3000 | 2026-03-17 | 2026-10-21 | |
| ALIGN: A Non-randomised Study Delivering Injectable Lenacapavir for HIV Prevention Within a Pre-exposure Prophylaxis (PrEP) Choice Context in Cape Town, South Africa. Lenacapavir Injection, Cabotegravir (CAB) LA, Tenofovi-Emtricitabine (TDF/FTC) tablet - HIV | Not yet recruiting | Desmond Tutu HIV Foundation | 3700 | 2026-01-29 | 2026-02-05 | |
| Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy Lenacapavir - Human Immunodeficiency Virus | Phase 1 | Recruiting | National Institute of Allergy and Infectious Diseases (NIAID) | 50 | 2026-01-20 | 2026-10-15 |
| Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP Lenacapavir long-acting - HIV Prevention, HIV Pre-exposure Prophylaxis | Phase 4 | Recruiting | Duke University | 100 | 2026-01-13 | 2026-10-19 |
| 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 |
| 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 |
| Real World Use of Lenacapavir, as an add-on to an Optimized Background Regimen in France Lenacapavir Injection - HIV I Infection | Recruiting | Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | 80 | 2025-03-03 | 2025-05-22 | |
| 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 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 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 |
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HIV Infections (2) · Acquired Immunodeficiency Syndrome (1)
Gilead Sciences (22) · Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida (1) · Desmond Tutu HIV Foundation (1) · Duke University (1) · National Institute of Allergy and Infectious Diseases (NIAID) (1) · University of California, Los Angeles (1)
United States (23) · Puerto Rico (7) · South Africa (7) · Canada (6) · Australia (5) · Argentina (4) · Dominican Republic (4) · France (4) · Italy (4) · Japan (4) · Spain (4) · Germany (3) · Taiwan (3) · United Kingdom (3) · Mexico (2)
Chuen-Yen C Lau, M.D. (1) · Tonia Poteat, PhD (1)
PMID 41313173, PMID 32612233, PMID 34358495, PMID 40176256, PMID 41056006, PMID 41429026, PMID 41449429, PMID 41498432, PMID 41720146, PMID 41763229, PMID 42105781
2023 (5), 2025 (2), 2019 (1)