Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

4,570

Participants

Timeline

Start Date

December 19, 2016

Primary Completion Date

May 14, 2020

Study Completion Date

March 31, 2025

Conditions
HIV Infections
Interventions
DRUG

Cabotegravir Oral Tablet

30 mg tablet

DRUG

TDF/FTC tablets

300 mg/200 mg fixed-dose combination tablets

DRUG

Placebo for TDF/FTC tablets

DRUG

Placebo for cabotegravir oral tablet

DRUG

CAB LA

Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

DRUG

Placebo for CAB LA

Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

Trial Locations (43)

1

ACSA CRS, Iquitos

7925

Groote Schuur HIV CRS, Cape Town

10010

Weill Cornell Chelsea CRS, New York

10027

Harlem Prevention Center CRS, New York

10065

New York Blood Center CRS, New York

10330

Thai Red Cross AIDS Research Centre (TRC-ARC) CRS, Pathum Wan

10451

Bronx Prevention Research Center CRS, The Bronx

11000

Silom Community Clinic CRS, Bangkok

15001

Via Libre CRS, Lima

15063

Barranco CRS, Lima

15081

CITBM - UNIDEC, Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS, Bellavista

19104

Penn Prevention CRS, Philadelphia

21205

Johns Hopkins University CRS, Baltimore

27401

Greensboro CRS, Greensboro

27599

Chapel Hill CRS, Chapel Hill

30030

The Hope Clinic of the Emory Vaccine Center CRS, Decatur

35294

Alabama CRS, Birmingham

43210

Ohio State University CRS, Columbus

45219

Cincinnati Clinical Research Site, Cincinnati

50202

CMU HIV Prevention CRS, Chiang Mai

60612

Adolescent & Young Adult Research at The CORE Center (AYAR at CORE), Chicago

UIC Project WISH CRS, Chicago

70112

New Orleans Adolescent Trials Unit CRS, New Orleans

77030

Houston AIDS Research Team CRS, Houston

80045

Children's Hospital Colorado CRS, Aurora

90024

UCLA Vine Street Clinic CRS, Los Angeles

90035

UCLA CARE Center CRS, Los Angeles

94143

Bridge HIV CRS, San Francisco

94609

East Bay AIDS Center (EBAC) CRS, Oakland

100000

Yen Hoa Health Clinic CRS, Hanoi

20037-1894

George Washington Univ. CRS, Washington D.C.

30308-2012

The Ponce de Leon Center CRS, Atlanta

02215-4302

Fenway Health (FH) CRS, Boston

63110-1010

Washington University Therapeutics (WT) CRS, St Louis

07103

New Jersey Medical School Clinical Research Center CRS, Newark

38105-3678

St. Jude Children's Research Hospital CRS, Memphis

C1221ADC

Hospital General de Agudos JM Ramos Mejía CRS, Ciudad de Buenos Aires

C1202ABB

Fundacion Huesped CRS, Buenos Aires

91350-200

Hospital Nossa Senhora da Conceicao CRS, Porto Alegre

04121-000

Centro de Referencia e Treinamento DST/AIDS CRS, São Paulo

21040-360

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS, Rio de Janeiro

05403-010

Centro de Pesquisas Clínicas IC-HCFMUSP CRS, São Paulo

32 - 15088

San Miguel CRS, Lima

Sponsors
All Listed Sponsors
collaborator

ViiV Healthcare

INDUSTRY

collaborator

Gilead Sciences

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02720094 - Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men | Biotech Hunter | Biotech Hunter