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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
2026-04-03
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 (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