Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection
3상
진행 중(모집 완료)
NCT04994509
| 대상 질환 | Pre-Exposure Prophylaxis of HIV Infection |
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| 임상 단계 | 3상 |
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| 스폰서 | Gilead Sciences |
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| 상태 | 진행 중(모집 완료) |
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| 참여자 수 | 5,368 명 |
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| 중재(약물) | Oral Lenacapavir (LEN), Subcutaneous (SC) Lenacapavir (LEN), F/TAF, F/TDF, Placebo SC LEN |
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| 시작일 | 2021년 8월 30일 |
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| 완료일 | 2024년 5월 27일 |
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| 결과 공개일 | 2025년 6월 19일 |
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요약
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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