RecruitingPhase 3NCT07047716

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

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

Sponsor

Gilead Sciences

Enrollment

350 participants

Start Date

Jul 22, 2025

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study is testing lenacapavir — a long-acting HIV prevention injection given once a year — as pre-exposure prophylaxis (PrEP) for people at risk of HIV. Current PrEP options require daily pills or more frequent injections; a once-yearly shot could dramatically improve adherence and access. **You may be eligible if...** - You are at least 16 years old - You have had receptive anal or vaginal sex in the past 6 months - You meet at least one risk criterion: condomless sex with a partner of unknown HIV status, recent STI diagnosis (syphilis, gonorrhea, chlamydia), or sex with an HIV-positive partner with unknown or detectable viral load - You test HIV-negative at screening **You may NOT be eligible if...** - You currently have signs or symptoms suggesting HIV infection - You have chronic hepatitis B or C, or acute viral hepatitis - You have severe liver disease or cirrhosis - You have participated in an HIV vaccine study using active product - You have used lenacapavir recently (oral in past 90 days or injectable in past 18 months) Talk to your doctor to see if this trial is right for you.

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 intramuscularly

DRUGLenacapavir 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

View Full Details on ClinicalTrials.gov

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NCT07047716