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

Clinical trial · Gilead Sciences

- Archive id: nct:NCT04925752
- Published: 2021-06-14
- Venue: ClinicalTrials.gov
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT04925752
- Source URL: https://clinicaltrials.gov/study/NCT04925752
- Provenance: clinicaltrials

## Abstract

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.

_Abstract reproduced under 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._

## 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

Topics: [Infectious Disease, Vaccines & Antimicrobial Resistance](https://space-kitty.com/topics/infectious-disease-amr)

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