Clinical Research Directory
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Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)
Sponsor: Gilead Sciences
Summary
The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of once-yearly intramuscular for HIV pre-exposure prophylaxis (PrEP) in people with an indication for PrEP. The primary objective of this study is to evaluate the pharmacokinetics (PK) and the safety and tolerability of intramuscular (IM) every 12 months (Q12M) LEN for PrEP among people with an indication for PrEP.
Official title: A Phase 3, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Once-Yearly Intramuscular Lenacapavir for HIV Pre-exposure Prophylaxis (PrEP) in People With an Indication for PrEP
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2025-07-22
Completion Date
2028-09
Last Updated
2026-03-04
Healthy Volunteers
Yes
Conditions
Interventions
Lenacapavir Injection
Administered intramuscularly
Lenacapavir Tablet
Administered orally
Locations (31)
UAB Sexual Health Research Clinic
Birmingham, Alabama, United States
UCLA Clinic Care
Los Angeles, California, United States
Ruane Clinical Research Group, Inc.
Los Angeles, California, United States
UCLA Vine Street Clinic
Los Angeles, California, United States
Mills Clinical Research
Los Angeles, California, United States
BIOS Clinical Research
Palm Springs, California, United States
UCSD AntiViral Research Center (AVRC)
San Diego, California, United States
Bridge HIV, San Francisco Department of Public Health
San Francisco, California, United States
Yale University; School of Medicine; AIDS Program
New Haven, Connecticut, United States
Whitman-Walker Institute, Inc.
Washington D.C., District of Columbia, United States
Children's National Hospital
Washington D.C., District of Columbia, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
The ID Prevention Research Unit
Miami, Florida, United States
University of South Florida - Curran Children's Health Center
Tampa, Florida, United States
The Hope Clinic of Emory University
Atlanta, Georgia, United States
Ponce de Leon Center Clinical Research Site
Atlanta, Georgia, United States
University of Illinois-Chicago (UIC), Center for Dissemination and Implementation Sciences (CDIS)
Chicago, Illinois, United States
Howard Brown Health Center
Chicago, Illinois, United States
University Medical Center
New Orleans, Louisiana, United States
Johns Hopkins Hospital - Clinical Research Unit
Baltimore, Maryland, United States
Fenway Health
Boston, Massachusetts, United States
Be Well Medical Center
Berkley, Michigan, United States
Icahn School of Medicine at Mount Sinai - Clinical and Translational Research Center
New York, New York, United States
ICAP at Columbia University- Bronx Prevention Center
The Bronx, New York, United States
NC TraCS Institute - CTRC, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Penn Prevention Unit
Philadelphia, Pennsylvania, United States
Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center
Philadelphia, Pennsylvania, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Central Texas Clinical Research
Austin, Texas, United States
The Crofoot Research Center
Houston, Texas, United States
Vaccine Trials Unit - Fred Hutchinson Cancer Center / University of Washington
Seattle, Washington, United States