Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Pre-Exposure Prophylaxis of HIV Infection
In brief
The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) in preventing HIV infection, in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV-1 infection. The primary objective of this study is to evaluate the efficacy of LEN for HIV-1 PrEP in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth at risk of HIV-1 infection.
Key facts
- Study ID
- NCT04925752
- Run by
- Gilead Sciences
- People needed
- 3292
- Starts
- 2021-06-28
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2025-12-23
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- Loma Linda University Clinical Trial Center Clinic — Loma Linda, California, United States
- Ruane Clinical Research Group Inc. — Los Angeles, California, United States
- UCLA CBAM Vine Street Clinic — Los Angeles, California, United States
- Charles R. Drew University of Medicine and Science (CDU) - Clinical Translational Research Center (CTRC) — Los Angeles, California, United States
- Mills Clinical Research — Los Angeles, California, United States
- The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Los Angeles, California, United States
- BIOS Clinical Research — Palm Springs, California, United States
- UCSD Anti Viral Research Center — San Diego, California, United States
- Bridge HIV at the San Francisco Department of Public Health — San Francisco, California, United States
- Optimus Medical Group — San Francisco, California, United States
- University of Colorado Clinical and Translational Research Centers (CTRC) — Aurora, Colorado, United States
- Yale University, School of Medicine — New Haven, Connecticut, United States
- Whitman-Walker Institute Inc. — Washington D.C., District of Columbia, United States
- Washington Health Institute — Washington D.C., District of Columbia, United States
- Therafirst Medical Center — Fort Lauderdale, Florida, United States
- Gary Richmond, MD, PA — Fort Lauderdale, Florida, United States
- Midway Immunology & Research Center, LLC — Ft. Pierce, Florida, United States
- CAN Community Health Clinic — Jacksonville, Florida, United States
- University of Miami Miller School of Medicine Division of Infectious Disease Research - Converge Miami — Miami, Florida, United States
- CAN Community Health — Miami Gardens, Florida, United States
- Orlando Immunology Center — Orlando, Florida, United States
- CAN Community Health — Sarasota, Florida, United States
- The Hope Clinic at Emory University — Atlanta, Georgia, United States
- Emory University — Atlanta, Georgia, United States
- UAB Sexual Health Research Clinic — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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