Clinical Trial

Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection

Study acronym: PURPOSE 2
Active, Not Recruiting Phase 3
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Summary
The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) in preventing HIV infection, in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV-1 infection. The primary objective of this study is to evaluate the efficacy of LEN for HIV-1 PrEP in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth at risk of HIV-1 infection.
Protocol Amendment History 41 amendments
This ClinicalTrials.gov record has been amended 41 times since 2021-06-11; most recent amendment 2025-12-05.
Status change: Recruiting → Active, Not Recruiting 2023-12-20
Status change: Active, Not Recruiting → Recruiting 2022-06-28
Status change: Recruiting → Active, Not Recruiting 2022-01-11
Status change: Not Yet Recruiting → Recruiting 2021-07-12
Trial Details
NCT Number NCT04925752
Lead Sponsor Gilead Sciences
Conditions Pre-Exposure Prophylaxis of HIV Infection
Enrollment 3,292 participants
Start Date 2021-06-28
Primary Completion 2024-08-21 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2025-12-23