Study Details

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.

Participation Requirements

Age

16 Years +

Sex

ALL

Healthy Volunteers

true

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

PHASE3

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

UCLA Clinic Care

Los Angeles, California, United States, 90035

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

The ID Prevention Research Unit

Miami, Florida, United States, 33136

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

Howard Brown Health Center

Chicago, Illinois, United States, 60613

University Medical Center

New Orleans, Louisiana, United States, 70119

Johns Hopkins Hospital - Clinical Research Unit

Baltimore, Maryland, United States, 21287

Fenway Health

Boston, Massachusetts, United States, 02215

Be Well Medical Center

Berkley, Michigan, United States, 48072

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

Central Texas Clinical Research

Austin, Texas, United States, 78705

The Crofoot Research Center

Houston, Texas, United States, 77098

Vaccine Trials Unit - Fred Hutchinson Cancer Center / University of Washington

Seattle, Washington, United States, 98104

Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP) (PURPOSE 365)