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

Study 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.

Conditions

Pre-Exposure Prophylaxis of HIV Infection

Interventions / Drugs

Oral Lenacapavir (LEN)F/TDF Sub-cutaneous (SC) Lenacapavir (LEN)Placebo SC LEN PTM F/TDF PTM Oral LEN F/TAF (for US participants only)

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment3292 participants

Primary Completion—

Lead SponsorGilead Sciences

Data Retrieved2026-04-11 02:55:27.113323+00:00

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