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
Status: Recruiting
Location: See all (31) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: t
View:
• 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:
‣ Condomless receptive sex (vaginal or anal) with 1 or more sex partners of unknown HIV status during the past 6 months
⁃ 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
⁃ For a person who has engaged in vaginal sex in the past 6 months: diagnosis of syphilis or gonorrhea in the past 6 months
⁃ 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.
Locations
United States
Alabama
UAB Sexual Health Research Clinic
RECRUITING
Birmingham
California
Mills Clinical Research
RECRUITING
Los Angeles
Ruane Clinical Research Group, Inc.
RECRUITING
Los Angeles
UCLA Clinic Care
RECRUITING
Los Angeles
UCLA Vine Street Clinic
RECRUITING
Los Angeles
BIOS Clinical Research
RECRUITING
Palm Springs
UCSD AntiViral Research Center (AVRC)
RECRUITING
San Diego
Bridge HIV, San Francisco Department of Public Health
RECRUITING
San Francisco
Connecticut
Yale University; School of Medicine; AIDS Program
RECRUITING
New Haven
Washington, D.c.
Children's National Hospital
RECRUITING
Washington D.c.
Whitman-Walker Institute, Inc.
RECRUITING
Washington D.c.
Florida
Midway Immunology and Research Center
RECRUITING
Ft. Pierce
The ID Prevention Research Unit
RECRUITING
Miami
University of South Florida - Curran Children's Health Center
RECRUITING
Tampa
Georgia
Ponce de Leon Center Clinical Research Site
NOT_YET_RECRUITING
Atlanta
The Hope Clinic of Emory University
RECRUITING
Atlanta
Illinois
Howard Brown Health Center
RECRUITING
Chicago
University of Illinois-Chicago (UIC), Center for Dissemination and Implementation Sciences (CDIS)
RECRUITING
Chicago
Louisiana
University Medical Center
RECRUITING
New Orleans
Massachusetts
Fenway Health
RECRUITING
Boston
Maryland
Johns Hopkins Hospital - Clinical Research Unit
RECRUITING
Baltimore
Michigan
Be Well Medical Center
RECRUITING
Berkley
North Carolina
NC TraCS Institute - CTRC, University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
New York
Icahn School of Medicine at Mount Sinai - Clinical and Translational Research Center
RECRUITING
New York
ICAP at Columbia University- Bronx Prevention Center
RECRUITING
The Bronx
Pennsylvania
Penn Prevention Unit
RECRUITING
Philadelphia
Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center
RECRUITING
Philadelphia
Tennessee
St. Jude Children's Research Hospital
RECRUITING
Memphis
Texas
Central Texas Clinical Research
RECRUITING
Austin
The Crofoot Research Center
RECRUITING
Houston
Washington
Vaccine Trials Unit - Fred Hutchinson Cancer Center / University of Washington
RECRUITING
Seattle
Contact Information
Primary
Gilead Clinical Study Information Center
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)
Time Frame
Start Date:2025-07-22
Estimated Completion Date:2028-09
Participants
Target number of participants:350
Treatments
Experimental: 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.
Experimental: 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.