Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)
NCT ID: NCT07047716
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2025-07-22
2028-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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.
Lenacapavir Injection
Administered intramuscularly
Lenacapavir Tablet
Administered orally
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.
Lenacapavir Injection
Administered intramuscularly
Lenacapavir Tablet
Administered orally
Interventions
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Lenacapavir Injection
Administered intramuscularly
Lenacapavir Tablet
Administered orally
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
16 Years
ALL
Yes
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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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
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
Midway Immunology and Research Center
Ft. Pierce, 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
Howard Brown Health Center
Chicago, Illinois, United States
University Medical Center
New Orleans, Louisiana, 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
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
Central Texas Clinical Research
Austin, Texas, United States
The Crofoot Research Center
Houston, Texas, United States
Countries
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Central Contacts
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Gilead Clinical Study Information Center
Role: CONTACT
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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GS-US-712-7286
Identifier Type: -
Identifier Source: org_study_id