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 (PURPOSE 1)
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- STATUS
- Recruiting
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- End date
- Jul 23, 2027
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- participants needed
- 5010
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- sponsor
- Gilead Sciences
Summary
The primary objective of this study is to evaluate the efficacy of lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF) in preventing the risk of human immunodeficiency virus (HIV) infection relative to the background HIV incidence rate.
The study will be conducted in 2 parts: a cross-sectional study (Incidence Phase) and a double-blind, randomized study (Randomized Phase). The Incidence Phase will include initial assessments that will provide an estimate of the concurrent background HIV incidence rate. The Randomized Phase of the study will have a Blinded Phase, a LEN Open-label Extension (OLE) Phase, and a Pharmacokinetic (PK) Tail Coverage Phase.
The primary objective for the Incidence Phase of this study is to estimate the HIV background incidence rate. The primary objectives of the Randomized Phase of this study are to evaluate the efficacy of LEN and F/TAF for HIV pre-exposure prophylaxis (PrEP) in adolescent girls and young women (AGYW) at risk of HIV infection.
Details
| Condition | Pre-Exposure Prophylaxis of HIV Infection |
|---|---|
| Treatment | F/TAF, F/TDF, Oral Lenacapavir (LEN), Placebo SC LEN, PTM F/TDF, PTM Oral LEN, Subcutaneous (SC) Lenacapavir (LEN), PTM F/TAF |
| Clinical Study Identifier | NCT04994509 |
| Sponsor | Gilead Sciences |
| Last Modified on | 23 October 2022 |
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