RecruitingNCT07473778

Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention

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

Sponsor

Gilead Sciences

Enrollment

3,000 participants

Start Date

Mar 17, 2026

Study Type

OBSERVATIONAL

Conditions

HIV Infections

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cabotegravir (CAB), a drug called Emtricitabine/tenofovir alafenamide (F/TAF), and others for people with hiv infections. The study is currently recruiting participants at 10 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLenacapavir Injection

Administered via subcutaneous (SC) injection

DRUGEmtricitabine/tenofovir disoproxil fumarate (F/TDF)

Tablets administered orally

DRUGEmtricitabine/tenofovir alafenamide (F/TAF)

Tablets administered orally

DRUGCabotegravir (CAB)

Administered via intramuscular (IM) injection

DRUGLenacapavir Tablet

Administered orally

Locations(31)

UAB 1917 Research Clinic

Birmingham, Alabama, United States

Pacific Oaks Medical Group

Beverly Hills, California, United States

Ruane Clinical Research Group Inc.

Los Angeles, California, United States

Family Health Centers of San Diego

San Diego, California, United States

UC San Diego (UCSD) AntiViral Research Center (AVRC)

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

DOM/Project WISH Research Clinic

Chicago, Illinois, United States

Howard Brown Health

Chicago, Illinois, 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

Henry Ford Health

Detroit, Michigan, United States

The Aliveness Project

Minneapolis, Minnesota, United States

KC Care Health Center

Kansas City, Missouri, United States

Washington University School of Medicine Infectious Disease Clinical Research Unit

St Louis, Missouri, United States

University of Nebraska Medical Center/Nebraska Medicine Specialty Care Center

Omaha, Nebraska, United States

NYC Health + Hospitals / Bellevue

New York, New York, United States

University of Cincinnati College of Medicine

Cincinnati, Ohio, United States

Ohio State University Infectious Diseases Clinical Trials Unit

Columbus, Ohio, United States

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Abounding Prosperity Inc.

Dallas, Texas, United States

Prism Health

Dallas, Texas, United States

UT Health

Houston, Texas, United States

Thomas Street at Quentin Mease Health Center

Houston, Texas, United States

West Virginia Health Right, Inc.

Charleston, West Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07473778

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