Pre-Exposure Prophylaxis Study of Lenacapavir in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People at Risk for HIV Infection

Brief 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 pre-exposure prophylaxis (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.

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

acronym

PURPOSE 2

status

ACTIVE_NOT_RECRUITING

phase

PHASE3

study type

INTERVENTIONAL

enrollment

3292

sponsor

Gilead Sciences

conditions

Pre-Exposure Prophylaxis of HIV Infection

interventions

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

start date

2021-06-28

start date type

ACTUAL

primary completion date

2024-08-21

has results

true

data source

ClinicalTrials.gov

data processed

2026-10-29T09:00:05

modifications

selected fields only; whitespace normalized; brief summary truncated to 2,000 characters