Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection
Phase 3
Active, not recruiting
NCT04994509
| Condition | Pre-Exposure Prophylaxis of HIV Infection |
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| Phase | Phase 3 |
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| Sponsor | Gilead Sciences |
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| Status | Active, not recruiting |
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| Enrollment | 5,368 participants |
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| Interventions | Oral Lenacapavir (LEN), Subcutaneous (SC) Lenacapavir (LEN), F/TAF, F/TDF, Placebo SC LEN |
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| Start date | Aug 30, 2021 |
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| Completion date | May 27, 2024 |
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| Results posted | Jun 19, 2025 |
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Summary
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.
Incidence Phase: Recent Infection Testing Algorithm (RITA) Estimate of the Background Human Immunodeficiency-1 Virus Infection Incidence Rate (bHIV) Per 100 Person Years (PY)
Incidence Phase Screening Visit (Day 1) · HIV-1 events per 100 person-years
| Participants Screened for HIV-1 in Incidence Phase | 2.407 HIV-1 events per 100 person-years |
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Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN and F/TAF Compared to Participants in All Screened Set
When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) · HIV-1 events per 100 person-years
| Randomized Blinded Phase: Lenacapavir | 0.000 HIV-1 events per 100 person-years |
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| Randomized Blinded Phase: F/TAF | 2.018 HIV-1 events per 100 person-years |
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| Incidence Phase: All Screened Participants With Non-missing HIV-1 Diagnosis | 2.407 HIV-1 events per 100 person-years |
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| p-value | <0.0001 |
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| Rate Ratio | 0.000 (95% CI 0.000–0.042) |
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Open in BENITIONS
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