Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)

Running, not enrolling · Phase 3

Conditions studied: HIV Pre-exposure Prophylaxis

In brief

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.

Key facts

Study ID

NCT07047716

Run by

Gilead Sciences

People needed

339

Starts

2025-07-22

Expected to finish

2028-09-01

Last updated by the study team

2026-06-22

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: accepted.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.