NCT04994509

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

A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,368 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: Female
• Age: 16 Years – 25 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Pre-Exposure Prophylaxis of HIV Infection

Interventions

Type	Name	Description
DRUG	Oral Lenacapavir (LEN)	Tablets administered orally without regard to food
DRUG	Subcutaneous (SC) Lenacapavir (LEN)	Administered via SC injections
DRUG	F/TAF	Tablets administered orally
DRUG	F/TDF	Tablets administered orally
DRUG	Placebo SC LEN	Administered via SC injections
DRUG	PTM Oral LEN	Tablets administered orally
DRUG	PTM F/TAF	Tablets administered orally
DRUG	PTM F/TDF	Tablets administered orally

Timeline

• Start date: 2021-08-30
• Primary completion: 2024-05-27
• Completion: 2028-01-01
• First posted: 2021-08-06
• Last updated: 2026-03-30
• Results posted: 2025-06-19

Locations

28 sites across 2 countries: South Africa, Uganda

Regulatory

• FDA-regulated drug study