STATUS Recruitment Complete

Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection (PURPOSE 2)

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

STATUS

Recruitment Complete

GILEAD STUDY ID

GS-US-528-9023

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

LAST UPDATED

December 23, 2025

Clinicaltrials.gov ID

NCT04925752

CTSID

DOH-27-102021-6681

OVERVIEW

A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People ≥ 16 Years of Age Who Have Sex With Male Partners and Are at Risk for HIV Infection (PURPOSE 2)

PROTOCOL SUMMARY

The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) in preventing HIV infection, in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV-1 infection. The primary objective of this study is to evaluate the efficacy of LEN for HIV-1 PrEP in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth at risk of HIV-1 infection.

Participation requirements

Age

16 years +

Sex

All

Healthy Volunteers

true

Study details

Medical Condition

Pre-Exposure Prophylaxis of HIV Infection

Gender

Cisgender male (CGM), Transgender male (TGM), Transgender women (TGW), and Gender non-binary (GNB)

Date

June 2021 - August 2024

Study Type

Interventional

Study Phase

Phase 3

Product

Oral Lenacapavir (LEN), F/TDF, Sub-cutaneous (SC) Lenacapavir (LEN), Placebo SC LEN, PTM F/TDF, PTM Oral LEN, F/TAF (for US participants only)

Eligibility information

Inclusion criteria

Incidence Phase
CGM, TGW, TGM, and GNB who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV infection.
HIV-1 status unknown at screening and no prior HIV-1 testing within the last 3 months.
Sexually active with ≥ 1 partner assigned male at birth (condomless receptive anal sex) in the last 12 months and 1 of the following:
Condomless receptive anal sex with ≥ 2 partners in the last 12 weeks.
History of syphilis, rectal gonorrhea, or rectal chlamydia in the last 24 weeks.
Self-reported use of stimulants with sex in the last 12 weeks.
Randomized Phase
Negative local rapid fourth generation HIV-1/2 Ab/Ag, central fourth generation HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT).
Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr).

Exclusion criteria

Incidence Phase
Prior use of HIV PrEP (including F/TDF or F/TAF) or HIV postexposure prophylaxis (PEP) in the past 12 weeks or any prior use of long-acting systemic PrEP (including cabotegravir or islatravir).
Prior recipient of an HIV vaccine or HIV broadly neutralizing antibody formulation.
Randomized Phase
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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

Locations (93)

UAB Sexual Health Research Clinic

Birmingham, Alabama, United States, 35233

Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection (PURPOSE 2)

For more information, please contact the

For more information, please contact the

OVERVIEW

PROTOCOL SUMMARY

Participation requirements

Study details

Eligibility information

Inclusion criteria

Exclusion criteria

Locations

Locations (93)

UAB Sexual Health Research Clinic

Loma Linda University Clinical Trial Center Clinic

Ruane Clinical Research Group Inc.

UCLA CBAM Vine Street Clinic

Charles R. Drew University of Medicine and Science (CDU) - Clinical Translational Research Center (CTRC)

Mills Clinical Research

The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

BIOS Clinical Research

UCSD Anti Viral Research Center

Bridge HIV at the San Francisco Department of Public Health

Optimus Medical Group

University of Colorado Clinical and Translational Research Centers (CTRC)

Yale University, School of Medicine

Whitman-Walker Institute Inc.

Washington Health Institute

Therafirst Medical Center

Gary Richmond, MD, PA

Midway Immunology & Research Center, LLC

CAN Community Health Clinic

University of Miami Miller School of Medicine Division of Infectious Disease Research - Converge Miami

CAN Community Health

Orlando Immunology Center

CAN Community Health

The Hope Clinic at Emory University

Emory University

Emory University Hospital Midtown Infectious Disease Clinic

RMR Core Center

University of Illinois at Chicago, Department of Medicine, Division of Infectious Diseases, Project WISH

Howard Brown Health Center

Indiana University Infectious Diseases Research

Baptist Health Lexington

Norton Infectious Disease Specialists

LSU-CrescentCare Sexual Health Center- New Orleans Community Health Center

Johns Hopkins University School of Medicine

The Fenway Institute

Be Well Medical Center

Henry Ford Hospital

Open Arms Healthcare Center

KC CARE Health Center

St. Michael's Medical Center

South Jersey Infectious Disease

Icahn School of Medicine at Mount Sinai- Mount Sinai Downtown

NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill

Cone Health/Regional Center for Infectious Disease Research Center

Wake Forest University Health Sciences

University of Cincinnati

The Ohio State University Wexner Medical Center

Penn Prevention Unit

Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center

Medical University of South Carolina, Infectious Disease Clinic

Prisma Health-Midlands Clinical Research Unit

Prisma Health Internal Medicine Clinic

Methodist University Hospital/University of Tennessee Health Science Center, Clinical Research Center

St Jude Children's Research Hospital

Meharry Medical College Clinical and Transitional Research Center

Central Texas Clinical Research

Centro San Vincente

UT Health Science Center at Houston

The Crofoot Research Center, INC

Ofiice of Dr. Peter Shalit, MD

Hospital General de Agudos JM Ramos Mejia

Fundacion Huesped

Instituto de Investigaciones Clinicas Mar del Plata

Unidade de Pesquisa Clinica em Vacinas (UPqVac) da Faculdade de Medicina da Universidade

Fundação Bahiana de Infectologia

Fundação de Medicina Tropical Doutor Heitor Vieira Dourado / Fundação Medicina Tropical do Amazonas - FMT/IMT/AM

Hospital General de Nova Iguaçu - HGNI

Grupo Hospitalar Conceição/ Hospital Nossa Senhora da Conceição S.A.