NCT07473778

Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention

Pioneering Research to Optimize Pre-exposure Prophylaxis (PrEP) Expansion With Lenacapavir (LEN)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The goal of this observational study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States. The study will characterize how PrEP is initiated, used, and discontinued in routine clinical practice when LEN is added as PrEP option and will evaluate persistence on LEN PrEP. The primary objective of this study is to evaluate real-life persistence on LEN PrEP at Week 52 in diverse clinical settings in the United States.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Lenacapavir Injection	Administered via subcutaneous (SC) injection
DRUG	Emtricitabine/tenofovir disoproxil fumarate (F/TDF)	Tablets administered orally
DRUG	Emtricitabine/tenofovir alafenamide (F/TAF)	Tablets administered orally
DRUG	Cabotegravir (CAB)	Administered via intramuscular (IM) injection
DRUG	Lenacapavir Tablet	Administered orally

Timeline

• Start date: 2026-03-17
• Primary completion: 2028-04-01
• Completion: 2029-04-01
• First posted: 2026-03-16
• Last updated: 2026-04-03

Locations

4 sites across 1 country: United States