OVERVIEW
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 (PURPOSE 365)
PROTOCOL 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.
View moreParticipation requirements
Age
16 years +
Sex
All
Healthy Volunteers
true
Age
16 years +
Sex
All
Healthy Volunteers
true
Study details
Medical Condition
HIV Pre-exposure Prophylaxis
Gender
Cisgender men, Transgender women, Transgender men, Cisgender women, and Gender non-binary
Date
July 2025 - September 2028
Study Type
Interventional
Study Phase
Phase 3
Product
Lenacapavir Injection, Lenacapavir Tablet
Eligibility information
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.
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.
Locations
Locations (31)
UAB Sexual Health Research Clinic
Birmingham, Alabama, United States, 35233
Ruane Clinical Research Group, Inc.
Los Angeles, California, United States, 90036
UCLA Vine Street Clinic
Los Angeles, California, United States, 90038
Mills Clinical Research
Los Angeles, California, United States, 90069
BIOS Clinical Research
Palm Springs, California, United States, 92262
UCSD AntiViral Research Center (AVRC)
San Diego, California, United States, 92103
Bridge HIV, San Francisco Department of Public Health
San Francisco, California, United States, 94102
Yale University; School of Medicine; AIDS Program
New Haven, Connecticut, United States, 06510
Whitman-Walker Institute, Inc.
Washington D.C., District of Columbia, United States, 20009
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Midway Immunology and Research Center
Ft. Pierce, Florida, United States, 34982
University of South Florida - Curran Children's Health Center
Tampa, Florida, United States, 33606
The Hope Clinic of Emory University
Atlanta, Georgia, United States, 30030
Ponce de Leon Center Clinical Research Site
Atlanta, Georgia, United States, 30303
University of Illinois-Chicago (UIC), Center for Dissemination and Implementation Sciences (CDIS)
Chicago, Illinois, United States, 60612
University Medical Center
New Orleans, Louisiana, United States, 70119
Johns Hopkins Hospital - Clinical Research Unit
Baltimore, Maryland, United States, 21287
Icahn School of Medicine at Mount Sinai - Clinical and Translational Research Center
New York, New York, United States, 10029
ICAP at Columbia University- Bronx Prevention Center
The Bronx, New York, United States, 10451
NC TraCS Institute - CTRC, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Penn Prevention Unit
Philadelphia, Pennsylvania, United States, 19104
Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center
Philadelphia, Pennsylvania, United States, 19107
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Vaccine Trials Unit - Fred Hutchinson Cancer Center / University of Washington
Seattle, Washington, United States, 98104
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