NCT06513312

Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)

A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Persistence, Safety, Acceptability, and Pharmacokinetics of Twice Yearly Long-acting Subcutaneous Lenacapavir for HIV Pre-Exposure Prophylaxis (PrEP) in People Who Would Benefit From PrEP

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 268 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goals of this clinical study are to learn more about the study drug lenacapavir (LEN), by comparing the consistent and continuous use of LEN and emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®) (F/TDF), then by observing the safety of LEN and F/TDF, evaluating the acceptability of LEN injections and oral F/TDF, and observe how LEN moves throughout the body in people who would benefit from pre-exposure prophylaxis (PrEP). The primary objective of this study is to compare LEN and F/TDF consistent and continuous use among people who would benefit from PrEP.

Conditions

• Pre-Exposure Prophylaxis of HIV Infection

Interventions

Type	Name	Description
DRUG	Lenacapavir Injection	Administered subcutaneously
DRUG	Lenacapavir Tablet	Administered orally
DRUG	Emtricitabine/tenofovir disoproxil fumarate (F/TDF)	Administered orally

Timeline

• Start date: 2024-10-07
• Primary completion: 2026-05-01
• Completion: 2028-12-01
• First posted: 2024-07-22
• Last updated: 2025-09-02

Locations

14 sites across 2 countries: France, United Kingdom

Regulatory

• FDA-regulated drug study