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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified February 2026 by Gilead Sciences
Sponsor
Gilead Sciences
Information Provided by (Responsible Party)
Gilead Sciences
Clinicaltrials.gov Identifier
NCT07047716
Other Study ID Numbers:
GS-US-712-7286
First Submitted
June 23, 2025
First Posted
July 1, 2025
Last Update Posted
March 3, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
HIV Pre-exposure Prophylaxis
Drug: Lenacapavir InjectionDrug: Lenacapavir Injection

Study Design

Study TypeInterventional
Actual Enrollment350 participants
Design AllocationNon-Randomized
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposePrevention
Official TitleA 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
Study Start DateJuly 21, 2025
Actual Primary Completion Date2yrs 2mos from now
Actual Study Completion Date2yrs 2mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Lenacapavir (LEN)
Participants with an indication for pre-exposure prophylaxis will receive for approximately 52 weeks: * LEN 3000 mg injection once on Day 1 * Oral LEN 600 mg on Day 1 and Day 2 during the Main Study Period Participant will receive additional oral LEN if IM injection are not available. If participants choose to not receive additional LEN injections, they will continue onto the pharmacokinetic (PK) Tail Phase for up to 52 weeks.
Drug: Lenacapavir Injection
Administered intramuscularly
LEN Extension Phase
Participants with an indication for pre-exposure prophylaxis will receive LEN 3000 mg injection once on Day 1 (approximately one year after their initial dose) during the Extension Phase. Participants will receive oral LEN if IM injections are not available. If participants choose to not receive additional LEN injections, they will continue onto the PK Tail Phase for up to 52 weeks.
Drug: Lenacapavir Injection
Administered intramuscularly

Outcome Measures

Primary Outcome Measures
  1. Plasma LEN Ctrough at Week 52
    Ctrough is defined as the concentration at the end of the dosing interval.
  2. Percentage of Participants Experiencing Treatment-emergent Adverse Event (TEAEs)
  3. Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities
  4. Percentage of Participants With Discontinuation due to Adverse Event

Eligibility Criteria

Ages Eligible for Study(Child, Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
Inclusion Criteria
At least 16 years of age at screening.
Receptive anal or vaginal sex in the past 6 months and at least 1 of the following: 1. Condomless receptive sex (vaginal or anal) with 1 or more sex partners of unknown HIV status during the past 6 months 2. For a person who has engaged in anal sex in the past 6 months: diagnosis of syphilis, gonorrhea, or chlamydia in the past 6 months 3. For a person who has engaged in vaginal sex in the past 6 months: diagnosis of syphilis or gonorrhea in the past 6 months 4. Sex with partner known to be living with HIV with an unknown or detectable viral load in the past 6 months
Negative local rapid fourth generation HIV-1/2 antibody (Ab)/antigen (Ag) test, central fourth generation HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT) at screening. Key
Exclusion Criteria
Current signs or symptoms suggesting HIV infection
Acute viral hepatitis A, B, or C or evidence of chronic hepatitis B or C infection
Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding)
Past or current participation in HIV vaccine or HIV broadly neutralizing antibody study unless participant provides documentation of receipt of placebo (ie, not active product)
Prior use of oral LEN in the past 90 days or subcutaneous LEN in the past 18 months Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Sponsors and CollaboratorsGilead Sciences
Locations
UAB Sexual Health Research Clinic | Birmingham Alabama, United States, 35233UCLA Clinic Care | Los Angeles California, United States, 90035Ruane Clinical Research Group, Inc. | Los Angeles California, United States, 90036UCLA Vine Street Clinic | Los Angeles California, United States, 90038Mills Clinical Research | Los Angeles California, United States, 90069BIOS Clinical Research | Palm Springs California, United States, 92262UCSD AntiViral Research Center (AVRC) | San Diego California, United States, 92103Bridge HIV, San Francisco Department of Public Health | San Francisco California, United States, 94102Yale University; School of Medicine; AIDS Program | New Haven Connecticut, United States, 06510Whitman-Walker Institute, Inc. | Washington D.C. District of Columbia, United States, 20009Children's National Hospital | Washington D.C. District of Columbia, United States, 20010Midway Immunology and Research Center | Ft. Pierce Florida, United States, 34982The ID Prevention Research Unit | Miami Florida, United States, 33136University of South Florida - Curran Children's Health Center | Tampa Florida, United States, 33606The Hope Clinic of Emory University | Atlanta Georgia, United States, 30030Ponce de Leon Center Clinical Research Site | Atlanta Georgia, United States, 30303University of Illinois-Chicago (UIC), Center for Dissemination and Implementation Sciences (CDIS) | Chicago Illinois, United States, 60612Howard Brown Health Center | Chicago Illinois, United States, 60613University Medical Center | New Orleans Louisiana, United States, 70119Johns Hopkins Hospital - Clinical Research Unit | Baltimore Maryland, United States, 21287Fenway Health | Boston Massachusetts, United States, 02215Be Well Medical Center | Berkley Michigan, United States, 48072Icahn School of Medicine at Mount Sinai - Clinical and Translational Research Center | New York New York, United States, 10029ICAP at Columbia University- Bronx Prevention Center | The Bronx New York, United States, 10451NC TraCS Institute - CTRC, University of North Carolina at Chapel Hill | Chapel Hill North Carolina, United States, 27599Penn Prevention Unit | Philadelphia Pennsylvania, United States, 19104Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center | Philadelphia Pennsylvania, United States, 19107St. Jude Children's Research Hospital | Memphis Tennessee, United States, 38105Central Texas Clinical Research | Austin Texas, United States, 78705The Crofoot Research Center | Houston Texas, United States, 77098Vaccine Trials Unit - Fred Hutchinson Cancer Center / University of Washington | Seattle Washington, United States, 98104
Investigators
Study Director: Gilead Study Director, Gilead Sciences