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Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
Sponsor: Gilead Sciences
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
2026-05-29
Healthy Volunteers
Not specified
Conditions
Interventions
Lenacapavir Injection
Administered via subcutaneous (SC) injection
Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
Tablets administered orally
Emtricitabine/tenofovir alafenamide (F/TAF)
Tablets administered orally
Cabotegravir (CAB)
Administered via intramuscular (IM) injection
Lenacapavir Tablet
Administered orally
Locations (17)
Pacific Oaks Medical Group
Beverly Hills, California, United States
Family Health Centers of San Diego
San Diego, California, United States
Mills Clinical Research
West Hollywood, California, United States
Vivent Health
Denver, Colorado, United States
Bliss Health
Orlando, Florida, United States
Pineapple Healthcare Orlando
Orlando, Florida, United States
AHF - Pensacola
Pensacola, Florida, United States
Faebris Medical & Community Education
Atlanta, Georgia, United States
The Clinic NOLA
New Orleans, Louisiana, United States
Chase Brexton Health Care
Baltimore, Maryland, United States
Fenway Health
Boston, Massachusetts, United States
Be Well Medical Center
Berkley, Michigan, United States
The Aliveness Project
Minneapolis, Minnesota, United States
KC Care Health Center
Kansas City, Missouri, United States
Ohio State University Infectious Diseases Clinical Trials Unit
Columbus, Ohio, United States
Abounding Prosperity Inc.
Dallas, Texas, United States
West Virginia Health Right, Inc.
Charleston, West Virginia, United States