NCT04994509Active, not recruitingPhase 3
Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection
A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF) in preventing HIV infection, in adolescent girls and young women (AGYW). The primary objective of this study is to evaluate the efficacy of LEN and F/TAF for HIV-1 PrEP in AGYW at risk of HIV-1 infection.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 5368 (actual)
- First submitted
- 2 Aug 2021
- Start date
- 30 Aug 2021
- Primary completion date
- 27 May 2024
- Lead sponsor
- Gilead Sciences
- Diseases
- HIV
- NCT number
- NCT04994509
- EudraCT number
- 2023-001024-42
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 5368
- From 30 Aug 2021 to the primary completion date, 27 May 2024
- 28 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior receipt of an HIV vaccine.
- Prior use of any long-acting systemic HIV pre-exposure prophylaxis (PrEP) or prior HIV postexposure prophylaxis (PEP) in the past 12 weeks.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Who the study is looking for
- Incidence Phase
- HIV-1 status unknown at initial screening and no prior human immunodeficiency virus (HIV)-1 testing within the last 3 months.
- Sexually active (has had \> 1 vaginal intercourse within the last 3 months) with cisgender male individuals (CGM).
- Randomized Phase
- Negative fourth generation HIV-1 antibody (Ab)/antigen (Ag) test confirmed with central HIV-1 testing.
- Estimated glomerular filtration rate (GFR) ≥ 60 mL/min at screening.
- Body weight ≥ 35 kg.
Age in the registry: 16 years to 25 years · Sex: Female · Accepts healthy volunteers
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Kalangala | Uganda | Unknown status |
| - Coordinator of this site? Confirm its status | Kyotera- Masaka Region | Uganda | Unknown status |
| Makerere University- John Hopkins University (MU-JHU) Mityana Research Site (MU-JHU) Care Ltd Coordinator of this site? Confirm its status | Mityana Town | Uganda | Unknown status |
| Madibeng Centre for Research Coordinator of this site? Confirm its status | Brits | South Africa | Unknown status |
| Vuka Research Clinic Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Desmond Tutu Health Foundation Clinical Trials Unit Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Emavundleni Research Centre Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Botha's Hill Clinical Research Site, HIV Prevention Research Unit Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| - Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| MatCH Research Unit, Suite 1112, 11th Floor Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| - Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| Synergy Biomed Research Institute (SBRI) Coordinator of this site? Confirm its status | East London | South Africa | Unknown status |
| Setshaba Research Centre Coordinator of this site? Confirm its status | Gauteng | South Africa | Unknown status |
| Wits Reproductive Health & HIV Institute (Wits RHI) Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| The Aurum Institute: Gavin J Churchyard Legacy Centre, Klerksdorp Clinical Research Centre Coordinator of this site? Confirm its status | Klerksdorp | South Africa | Unknown status |
| Perinatal HIV Research Unit (PHRU) Soweto Kliptown Coordinator of this site? Confirm its status | Kliptown | South Africa | Unknown status |
| Phoenix Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit Coordinator of this site? Confirm its status | Kwa Zulu Natal | South Africa | Unknown status |
| Verulam Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit Coordinator of this site? Confirm its status | Kwa Zulu Natal | South Africa | Unknown status |
| Chatsworth Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit Coordinator of this site? Confirm its status | Kwa Zulu Natal | South Africa | Unknown status |
| Tongaat Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit Coordinator of this site? Confirm its status | Kwa Zulu Natal | South Africa | Unknown status |
| Qhakaza Mbokodo Research Clinic Coordinator of this site? Confirm its status | Ladysmith | South Africa | Unknown status |
| Africa Health Research Institute Coordinator of this site? Confirm its status | Mtubatuba | South Africa | Unknown status |
| The Aurum Institute: Pretoria Clinical Research Centre Coordinator of this site? Confirm its status | Pretoria | South Africa | Unknown status |
| The Aurum Institute: Rustenburg Clinical Research Centre Coordinator of this site? Confirm its status | Rustenburg | South Africa | Unknown status |
| Desmond Tutu Health Foundation - Masiphumelele Research Office Coordinator of this site? Confirm its status | Sunnydale | South Africa | Unknown status |
| The Aurum Institute: Tembisa Clinical Research Centre Coordinator of this site? Confirm its status | Tembisa | South Africa | Unknown status |
| - Coordinator of this site? Confirm its status | Umlazi | South Africa | Unknown status |
| - Coordinator of this site? Confirm its status | Vincent | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.