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RECRUITING
NCT07473778

Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

3000

Start Date

2026-03-17

Completion Date

2029-04

Last Updated

2026-04-03

Healthy Volunteers

Not specified

Conditions

Interventions

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

Locations (4)

Bliss Health

Orlando, Florida, United States

Faebris Medical & Community Education

Atlanta, Georgia, United States

Be Well Medical Center

Berkley, Michigan, United States

KC Care Health Center

Kansas City, Missouri, United States