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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

3,292

Participants

Timeline

Start Date

June 28, 2021

Primary Completion Date

August 21, 2024

Study Completion Date

May 31, 2028

Conditions
Pre-Exposure Prophylaxis of HIV Infection
Interventions
DRUG

Oral Lenacapavir (LEN)

Tablets administered orally without regard to food

DRUG

F/TDF

Tablets administered orally

DRUG

Sub-cutaneous (SC) Lenacapavir (LEN)

Administered via SC injections

DRUG

Placebo SC LEN

Administered via SC injections

DRUG

PTM F/TDF

Tablets administered orally

DRUG

PTM Oral LEN

Tablets administered orally

DRUG

F/TAF (for US participants only)

F/TAF tablets administered orally once daily

Trial Locations (91)

87

The Aurum Institute: Pretoria Clinical Research Centre, Pretoria

1072

Hospital General de Agudos JM Ramos Mejia, Buenos Aires

1202

Fundacion Huesped, Buenos Aires

1632

The Aurum Institute Tembisa CRC, Clinic 4, Tembisa

2038

Wits Reproductive Health and HIV Institute (Wits RHI), Johannesburg

5217

FPD-DTHF Ndevana Commuity Research Site, Vincent

7006

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

7925

Desmond Tutu Health Foundation, Cape Town

10029

Icahn School of Medicine at Mount Sinai- Mount Sinai Downtown, New York

10330

Institute of HIV Research and Innovation, Bangkok

King Chulalongkorn Memorial Hospital, Bangkok

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

10400

Ramathibodi Hospital, Mahidol University, Bangkok

11000

Bamrasnaradura Infectious Disease Institute, Nonthaburi

15001

Via Libre, Lima

15063

Asociacion Civil Impacta Salud y Educacion - Sede Barranco, Barranco

15088

Asociacion Civil Impacta Salud y Educacion - Sede San Miguel, Lima

19104

Penn Prevention Unit, Philadelphia

19107

Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center, Philadelphia

20009

Whitman-Walker Institute Inc., Washington D.C.

20017

Washington Health Institute, Washington D.C.

21287

Johns Hopkins University School of Medicine, Baltimore

27103

Wake Forest University Health Sciences, Winston-Salem

27401

Cone Health/Regional Center for Infectious Disease Research Center, Greensboro

27514

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

29203

Prisma Health-Midlands Clinical Research Unit, Columbia

29425

Medical University of South Carolina, Infectious Disease Clinic, Charleston

29605

Prisma Health Internal Medicine Clinic, Greenville

30030

The Hope Clinic at Emory University, Atlanta

30303

Emory University, Atlanta

30308

Emory University Hospital Midtown Infectious Disease Clinic, Atlanta

32803

Orlando Immunology Center, Orlando

33055

CAN Community Health, Miami Gardens

33136

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

33308

Therafirst Medical Center, Fort Lauderdale

33316

Gary Richmond, MD, PA, Fort Lauderdale

34237

CAN Community Health, Sarasota

34982

Midway Immunology & Research Center, LLC, Ft. Pierce

35233

UAB Sexual Health Research Clinic, Birmingham

37208

Meharry Medical College Clinical and Transitional Research Center, Nashville

38103

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

38105

St Jude Children's Research Hospital, Memphis

39202

Open Arms Healthcare Center, Jackson

40002

Srinagarind Hospital, Khon Kaen University, Khon Kaen

40241

Norton Infectious Disease Specialists, Louisville

40503

Baptist Health Lexington, Lexington

43210

The Ohio State University Wexner Medical Center, Columbus

44160

Centro de Investigacion Farmaceutica Especializada de Occidente S.C., Guadalajara C.P.

45267

University of Cincinnati, Cincinnati

46202

Indiana University Infectious Diseases Research, Indianapolis

48072

Be Well Medical Center, Berkley

48202

Henry Ford Hospital, Detroit

50200

Research Institute for Health Sciences, Chiang Mai University, Chiang Mai

60612

RMR Core Center, Chicago

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

60613

Howard Brown Health Center, Chicago

64111

KC CARE Health Center, Kansas City

70119

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

77098

The Crofoot Research Center, INC, Houston

78705

Central Texas Clinical Research, Austin

79915

Centro San Vincente, El Paso

80045

University of Colorado Clinical and Translational Research Centers (CTRC), Aurora

90036

Ruane Clinical Research Group Inc., Los Angeles

90038

UCLA CBAM Vine Street Clinic, Los Angeles

90059

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

90069

Mills Clinical Research, Los Angeles

90502

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

92103

UCSD Anti Viral Research Center, San Diego

92262

BIOS Clinical Research, Palm Springs

92354

Loma Linda University Clinical Trial Center Clinic, Loma Linda

94102

Bridge HIV at the San Francisco Department of Public Health, San Francisco

Optimus Medical Group, San Francisco

98104

Ofiice of Dr. Peter Shalit, MD, Seattle

06510

Yale University, School of Medicine, New Haven

02215

The Fenway Institute, Boston

07102

St. Michael's Medical Center, Newark

08244

South Jersey Infectious Disease, Somers Point

B7600

Instituto de Investigaciones Clinicas Mar del Plata, Buenos Aires

30130-100

Unidade de Pesquisa Clinica em Vacinas (UPqVac) da Faculdade de Medicina da Universidade, Belo Horizonte - MG

40110-060

Fundação Bahiana de Infectologia, Canela-Salvador

69040-000

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

26030-380

Hospital General de Nova Iguaçu - HGNI, Nova Iguaçu

RS 91350 200

Grupo Hospitalar Conceição/ Hospital Nossa Senhora da Conceição S.A., Porto Alegre

21040-360

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

01246-903

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

04121-000

Centro de Referência e Treinamento DST/AIDS, São Paulo

06519-332

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

Unknown

Asociacion Civil Selva Amazonica, Iquitos

00717

Ararat Research Center, San Juan

00909

Centro Ararat- San Juan, San Juan

0152

Setshaba Research Centre, Soshanguvhe

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY