NCT04925752

Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection

A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People ≥ 16 Years of Age Who Have Sex With Male Partners and Are at Risk for HIV Infection

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,292 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Pre-Exposure Prophylaxis of HIV Infection

Interventions

Type	Name	Description
DRUG	Oral Lenacapavir (LEN)	Tablets administered orally without regard to food
DRUG	F/TDF	Tablets administered orally
DRUG	Sub-cutaneous (SC) Lenacapavir (LEN)	Administered via SC injections
DRUG	Placebo SC LEN	Administered via SC injections
DRUG	PTM F/TDF	Tablets administered orally
DRUG	PTM Oral LEN	Tablets administered orally
DRUG	F/TAF (for US participants only)	F/TAF tablets administered orally once daily

Timeline

• Start date: 2021-06-28
• Primary completion: 2024-08-21
• Completion: 2028-08-01
• First posted: 2021-06-14
• Last updated: 2025-12-23
• Results posted: 2025-09-17

Locations

93 sites across 8 countries: United States, Argentina, Brazil, Mexico, Peru, Puerto Rico, South Africa, Thailand

Regulatory

• FDA-regulated drug study