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

> **NCT04994509** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Gilead Sciences** · enrollment: 5368 (actual)

## Conditions studied

- 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

## Key facts

- **NCT ID:** NCT04994509
- **Lead sponsor:** Gilead Sciences
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2021-08-30
- **Primary completion:** 2024-05-27
- **Final completion:** 2028-01
- **Target enrollment:** 5368 (ACTUAL)
- **Last updated:** 2026-03-30


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04994509

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04994509, "Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection". Retrieved via AI Analytics 2026-08-17 from https://api.ai-analytics.org/clinical/NCT04994509. Licensed CC0.

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