Study Details

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)

Participation Requirements

Age

16 Years +

Sex

ALL

Healthy Volunteers

true

Medical Condition

Pre-Exposure Prophylaxis of HIV Infection

Gender

Cisgender male, Transgender male, Transgender female, and Gender non-binary

Date

June 2021 - August 2024

Study Type

INTERVENTIONAL

Study Phase

PHASE3

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 (91)

UAB Sexual Health Research Clinic

Birmingham, Alabama, United States, 35233

Loma Linda University Clinical Trial Center Clinic

Loma Linda, California, United States, 92354

Ruane Clinical Research Group Inc.

Los Angeles, California, United States, 90036

UCLA CBAM Vine Street Clinic

Los Angeles, California, United States, 90038

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

Los Angeles, California, United States, 90059

Mills Clinical Research

Los Angeles, California, United States, 90069

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

Los Angeles, California, United States, 90502

BIOS Clinical Research

Palm Springs, California, United States, 92262

UCSD Anti Viral Research Center

San Diego, California, United States, 92103

Bridge HIV at the San Francisco Department of Public Health

San Francisco, California, United States, 94102

Optimus Medical Group

San Francisco, California, United States, 94102

University of Colorado Clinical and Translational Research Centers (CTRC)

Aurora, Colorado, United States, 80045

Yale University, School of Medicine

New Haven, Connecticut, United States, 06510

Whitman-Walker Institute Inc.

Washington, District of Columbia, United States, 20009

Washington Health Institute

Washington, District of Columbia, United States, 20017

Therafirst Medical Center

Fort Lauderdale, Florida, United States, 33308

Gary Richmond, MD, PA

Fort Lauderdale, Florida, United States, 33316

Midway Immunology & Research Center, LLC

Fort Pierce, Florida, United States, 34982

CAN Community Health

Miami Gardens, Florida, United States, 33055

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

Miami, Florida, United States, 33136

Orlando Immunology Center

Orlando, Florida, United States, 32803

CAN Community Health

Sarasota, Florida, United States, 34237

The Hope Clinic at Emory University

Atlanta, Georgia, United States, 30030

Emory University

Atlanta, Georgia, United States, 30303

Emory University Hospital Midtown Infectious Disease Clinic

Atlanta, Georgia, United States, 30308

RMR Core Center

Chicago, Illinois, United States, 60612

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

Chicago, Illinois, United States, 60612

Howard Brown Health Center

Chicago, Illinois, United States, 60613

Indiana University Infectious Diseases Research

Indianapolis, Indiana, United States, 46202

Baptist Health Lexington

Lexington, Kentucky, United States, 40503

Norton Infectious Disease Specialists

Louisville, Kentucky, United States, 40241

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

New Orleans, Louisiana, United States, 70119

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States, 21287

The Fenway Institute

Boston, Massachusetts, United States, 02215

Be Well Medical Center

Berkley, Michigan, United States, 48072

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Open Arms Healthcare Center

Jackson, Mississippi, United States, 39202

KC CARE Health Center

Kansas City, Missouri, United States, 64111

St. Michael's Medical Center

Newark, New Jersey, United States, 07102

South Jersey Infectious Disease

Somers Point, New Jersey, United States, 08244

Icahn School of Medicine at Mount Sinai- Mount Sinai Downtown

New York, New York, United States, 10029

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

Chapel Hill, North Carolina, United States, 27514

Cone Health/Regional Center for Infectious Disease Research Center

Greensboro, North Carolina, United States, 27401

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27103

University of Cincinnati

Cincinnati, Ohio, United States, 45267

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43210

Penn Prevention Unit

Philadelphia, Pennsylvania, United States, 19104

Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center

Philadelphia, Pennsylvania, United States, 19107

Medical University of South Carolina, Infectious Disease Clinic

Charleston, South Carolina, United States, 29425

Prisma Health-Midlands Clinical Research Unit

Columbia, South Carolina, United States, 29203

Prisma Health Internal Medicine Clinic

Greenville, South Carolina, United States, 29605

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

Memphis, Tennessee, United States, 38103

St Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Meharry Medical College Clinical and Transitional Research Center

Nashville, Tennessee, United States, 37208

Central Texas Clinical Research

Austin, Texas, United States, 78705

Centro San Vincente

El Paso, Texas, United States, 79915

The Crofoot Research Center, INC

Houston, Texas, United States, 77098

Ofiice of Dr. Peter Shalit, MD

Seattle, Washington, United States, 98104

Hospital General de Agudos JM Ramos Mejia

Buenos Aires, Argentina, 1072

Fundacion Huesped

Buenos Aires, Argentina, 1202

Instituto de Investigaciones Clinicas Mar del Plata

Buenos Aires, Argentina, B7600

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

Belo Horizonte - MG, Brazil, 30130-100

Fundação Bahiana de Infectologia

Canela-Salvador, Brazil, 40110-060

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

Manauas, Brazil, 69040-000

Hospital General de Nova Iguaçu - HGNI

Nova Iguaçu, Brazil, 26030-380

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

Porto Alegre, Brazil, RS 91350 200

Instituto Nacional de Infectologia Evandro Chagas / Fundação Oswaldo Cruz - INI FIOCRUZ

Rio de Janeiro, Brazil, 21040-360

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Sao Paulo, Brazil, 01246-903

Centro de Referência e Treinamento DST/AIDS

Sao Paulo, Brazil, 04121-000

Center for Management and Research. SPDM-Paulista Association for the Development of Medicine-Hospital São Paulo/Federal

Sao Paulo, Brazil, 06519-332

Centro de Investigacion Farmaceutica Especializada de Occidente S.C.

Guadalajara C.P., Mexico, 44160

Asociacion Civil Impacta Salud y Educacion - Sede Barranco

Barranco, Peru, 15063

Instituto de Medicina Tropical "Daniel Alcides Carrion", Facultad de Medicina Humana, UNMSM

Callao, Peru, 7006

Asociacion Civil Selva Amazonica

Iquitos, Peru

Via Libre

Lima, Peru, 15001

Asociacion Civil Impacta Salud y Educacion - Sede San Miguel

Lima, Peru, 15088

Ararat Research Center

San Juan, Puerto Rico, 00717

Centro Ararat- San Juan

San Juan, Puerto Rico, 00909

Desmond Tutu Health Foundation

Cape Town, South Africa, 7925

Wits Reproductive Health and HIV Institute (Wits RHI)

Johannesburg, South Africa, 2038

The Aurum Institute: Pretoria Clinical Research Centre

Pretoria, South Africa, 87

Setshaba Research Centre

Soshanguvhe, South Africa, 0152

The Aurum Institute Tembisa CRC, Clinic 4

Tembisa, South Africa, 1632

FPD-DTHF Ndevana Commuity Research Site

Vincent, South Africa, 5217

Institute of HIV Research and Innovation

Bangkok, Thailand, 10330

King Chulalongkorn Memorial Hospital

Bangkok, Thailand, 10330

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS research Centre

Bangkok, Thailand, 10330

Ramathibodi Hospital, Mahidol University

Bangkok, Thailand, 10400

Research Institute for Health Sciences, Chiang Mai University

Chiang Mai, Thailand, 50200

Srinagarind Hospital, Khon Kaen University

Khon Kaen, Thailand, 40002

Bamrasnaradura Infectious Disease Institute

Nonthaburi, Thailand, 11000

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

OVERVIEW

PROTOCOL SUMMARY

Participation Requirements

Eligibility Information

Inclusion Criteria

Exclusion Criteria

Locations

Locations (91)

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

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

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

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.

Instituto Nacional de Infectologia Evandro Chagas / Fundação Oswaldo Cruz - INI FIOCRUZ

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Centro de Referência e Treinamento DST/AIDS

Center for Management and Research. SPDM-Paulista Association for the Development of Medicine-Hospital São Paulo/Federal