NCT07047716

Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)

A Phase 3, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Once-Yearly Intramuscular Lenacapavir for HIV Pre-exposure Prophylaxis (PrEP) in People With an Indication for PrEP

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of once-yearly intramuscular for HIV pre-exposure prophylaxis (PrEP) in people with an indication for PrEP. The primary objective of this study is to evaluate the pharmacokinetics (PK) and the safety and tolerability of intramuscular (IM) every 12 months (Q12M) LEN for PrEP among people with an indication for PrEP.

Conditions

• HIV Pre-exposure Prophylaxis

Interventions

Type	Name	Description
DRUG	Lenacapavir Injection	Administered intramuscularly
DRUG	Lenacapavir Tablet	Administered orally

Timeline

• Start date: 2025-07-22
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2025-07-02
• Last updated: 2026-03-04

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated drug study