Actively Recruiting
Phase 3 Study Evaluating Safety, Tolerability, and Pharmacokinetics of Once-Yearly Intramuscular Lenacapavir for HIV Pre-exposure Prophylaxis (PrEP)
Led by Gilead Sciences · Updated on 2026-03-04
350
Participants Needed
31
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating lenacapavir (LEN), a drug given once yearly by injection, for HIV pre-exposure prophylaxis (PrEP). The study focuses on understanding how LEN is absorbed and processed in the body, as well as its safety and tolerability when given as a once-a-year intramuscular injection to people who have an indication for PrEP. This is a phase 3 clinical trial sponsored by Gilead Sciences.
CONDITIONS
Brief Title
Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 16 years of age at screening
- Receptive anal or vaginal sex in the past 6 months
- Condomless receptive sex with one or more partners of unknown HIV status in the past 6 months
- Diagnosis of syphilis, gonorrhea, or chlamydia in the past 6 months if anal sex was engaged in
- Diagnosis of syphilis or gonorrhea in the past 6 months if vaginal sex was engaged in
- Sex with partner known to be living with HIV with unknown or detectable viral load in the past 6 months
- Negative local rapid fourth generation HIV-1/2 antibody/antigen test, central fourth generation HIV-1/2 antibody/antigen, and HIV-1 RNA quantitative nucleic acid amplification testing at screening
You will not qualify if you...
- Current signs or symptoms suggesting HIV infection
- Acute viral hepatitis A, B, or C or evidence of chronic hepatitis B or C infection
- Severe liver impairment or history/current clinical decompensated liver cirrhosis
- Past or current participation in HIV vaccine or broadly neutralizing antibody study unless documented placebo receipt
- Prior use of oral lenacapavir in the past 90 days or subcutaneous lenacapavir in the past 18 months
- Other protocol defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 52 weeks
Participants receive Lenacapavir as a once-yearly intramuscular injection along with oral doses for HIV Pre-exposure Prophylaxis (PrEP).
1 injection visit and additional oral dosing on Days 1 and 2
Duration - Approximately 52 weeks
Participants in the Extension Phase receive a second Lenacapavir injection approximately one year after the initial dose, with oral doses if injections are unavailable.
1 injection visit
Duration - Up to 52 weeks
Participants who do not receive additional injections continue pharmacokinetic monitoring for up to 52 weeks after their last dose.
Visits frequency not specified
Trial Site Locations
Total: 31 locations
1
UAB Sexual Health Research Clinic
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
UCLA Clinic Care
Los Angeles, California, United States, 90035
Actively Recruiting
3
Ruane Clinical Research Group, Inc.
Los Angeles, California, United States, 90036
Actively Recruiting
4
UCLA Vine Street Clinic
Los Angeles, California, United States, 90038
Actively Recruiting
5
Mills Clinical Research
Los Angeles, California, United States, 90069
Actively Recruiting
6
BIOS Clinical Research
Palm Springs, California, United States, 92262
Actively Recruiting
7
UCSD AntiViral Research Center (AVRC)
San Diego, California, United States, 92103
Actively Recruiting
8
Bridge HIV, San Francisco Department of Public Health
San Francisco, California, United States, 94102
Actively Recruiting
9
Yale University; School of Medicine; AIDS Program
New Haven, Connecticut, United States, 06510
Actively Recruiting
10
Whitman-Walker Institute, Inc.
Washington D.C., District of Columbia, United States, 20009
Actively Recruiting
11
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
12
Midway Immunology and Research Center
Ft. Pierce, Florida, United States, 34982
Actively Recruiting
13
The ID Prevention Research Unit
Miami, Florida, United States, 33136
Actively Recruiting
14
University of South Florida - Curran Children's Health Center
Tampa, Florida, United States, 33606
Actively Recruiting
15
The Hope Clinic of Emory University
Atlanta, Georgia, United States, 30030
Actively Recruiting
16
Ponce de Leon Center Clinical Research Site
Atlanta, Georgia, United States, 30303
Not Yet Recruiting
17
University of Illinois-Chicago (UIC), Center for Dissemination and Implementation Sciences (CDIS)
Chicago, Illinois, United States, 60612
Actively Recruiting
18
Howard Brown Health Center
Chicago, Illinois, United States, 60613
Actively Recruiting
19
University Medical Center
New Orleans, Louisiana, United States, 70119
Actively Recruiting
20
Johns Hopkins Hospital - Clinical Research Unit
Baltimore, Maryland, United States, 21287
Actively Recruiting
21
Fenway Health
Boston, Massachusetts, United States, 02215
Actively Recruiting
22
Be Well Medical Center
Berkley, Michigan, United States, 48072
Actively Recruiting
23
Icahn School of Medicine at Mount Sinai - Clinical and Translational Research Center
New York, New York, United States, 10029
Actively Recruiting
24
ICAP at Columbia University- Bronx Prevention Center
The Bronx, New York, United States, 10451
Actively Recruiting
25
NC TraCS Institute - CTRC, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
26
Penn Prevention Unit
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
27
Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
28
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
29
Central Texas Clinical Research
Austin, Texas, United States, 78705
Actively Recruiting
30
The Crofoot Research Center
Houston, Texas, United States, 77098
Actively Recruiting
31
Vaccine Trials Unit - Fred Hutchinson Cancer Center / University of Washington
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
G
Gilead Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
2
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