# Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection

Clinical trial · Gilead Sciences

- Archive id: nct:NCT04994509
- Published: 2021-08-06
- Venue: ClinicalTrials.gov
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT04994509
- Source URL: https://clinicaltrials.gov/study/NCT04994509
- Provenance: clinicaltrials

## Abstract

The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF) in preventing HIV infection, in adolescent girls and young women (AGYW). The primary objective of this study is to evaluate the efficacy of LEN and F/TAF for HIV-1 PrEP in AGYW 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 1
- status: ACTIVE_NOT_RECRUITING
- phase: PHASE3
- study type: INTERVENTIONAL
- enrollment: 5368
- sponsor: Gilead Sciences
- conditions: Pre-Exposure Prophylaxis of HIV Infection
- interventions: DRUG: Oral Lenacapavir (LEN); DRUG: Subcutaneous (SC) Lenacapavir (LEN); DRUG: F/TAF; DRUG: F/TDF; DRUG: Placebo SC LEN; DRUG: PTM Oral LEN; DRUG: PTM F/TAF; DRUG: PTM F/TDF
- start date: 2021-08-30
- start date type: ACTUAL
- primary completion date: 2024-05-27
- 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)

---
Space Kitty Archive · https://space-kitty.com · API: https://space-kitty.com/api/v1 · MCP: https://space-kitty.com/mcp · Premium: $0.20/request via x402 (Base Sepolia (testnet)). Metadata: arXiv (CC0), OpenAlex (CC0), Europe PMC (CC BY/CC0 works), ClinicalTrials.gov.