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Status
Ongoing
Phase
III
IIb
Principal Investigator(s)
Raphael J. Landovitz, MD, MSc
Objective
This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW). For a diagram of the trial schema, click here.
May 18, 2020: Based on interim analysis by the Data and Safety Monitoring Board (DSMB), the blinded, randomized portion of the trial will be stopped early for efficacy. Participants who were in the FTC/TDF arm will be offered CAB LA and participants in the CAB LA arm will continue to receive it.
July 7, 2020: CAB and TDF/FTC were both safe and highly effective for PrEP in HPTN 083, with estimated incidence in the CAB arm 66% lower than in the TDF/FTC arm.
Last updated Aug 25, 2021
Prevention Option(s)
PrEP
Study Design
Randomized
Double-blind
Arms and Assigned Interventions
Description
Arm A: In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo. In Step 3, participants will receive daily oral TDF/FTC no later than 8 weeks after the last injection, for up to 48 weeks.
Mode of Delivery
Tablet
Intermuscular
Products
Cabotegravir (GSK 744)
TDF/FTC (Truvada)
ARMs
Experimental
Description
Arm B: In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA. In Step 3, participants will receive daily oral TDF/FTC no later than 8 weeks after the last injection, for up to 48 weeks.
Mode of Delivery
Tablet
Intermuscular
Products
Cabotegravir (GSK 744)
TDF/FTC (Truvada)
ARMs
Experimental
Official Code
Related Publications
Trial Sponsors
NIAID, Viiv Healthcare, Gilead
December 2016
March 2022
Enrollment
4 570
18
Years
Population
MSM
Sites
UCLA CARE Center CRS
Los Angeles, California
United States of America
Bridge HIV CRS
San Francisco, California
United States of America
George Washington University CRS
Washington, District of Columbia
United States of America
Johns Hopkins University
Baltimore, Maryland
United States of America
Adolescent & Young Adult Research at The CORE Center (AYAR at CORE)
Chicago, Illinois
United States of America
Fenway Health (FH) CRS
Boston, Massachusetts
United States of America
Harlem Prevention Center
New York, NY
United States of America
New York Blood Center
New York, New York
United States of America
Chapel Hill CRS
Chapel Hill, North Carolina
United States of America
Greensboro CRS
Chapel Hill, North Carolina
United States of America
Penn Prevention CRS
Philadelphia, Pennsylvania
United States of America
St. Jude Childrens Research Hospital
Memphis, Tennessee
United States of America
Houston AIDS Research Team CRS
Houston, Texas
United States of America
Chiang Mai University AIDS Prevention
Chiang Mai
Thailand
Fundacion Huesped
Buenos Aires
Argentina
Site(s) - Peru
Peru
Site(s) - India
India
Site(s) - Viet Nam
Vietnam
Hospital Nossa Senhora da Conceicao
Port Alegre, Rio Grande do Sul
Brazil
Site(s)-Argentina
Argentina
Site(s) - South Africa
South Africa
Groote Schuur HIV CRS
Cape Town
South Africa
Thai Red Cross AIDS Research Centre
Bangkok
Thailand
Silom Community Clinic
Bangkok
Thailand
San Miguel Clinical Research Site
Lima
Peru
Barranco CRS
Lima
Peru
Via Libre
Lima
Peru
Asociación Civil Selva Amazónica (ACSA)
Iquitos
Peru
Centro de Investigaciones Tecnologicas, Biomedica y medio ambientales (CITBM)
Callao
Peru
Centro de Referência e Treinamento
Sao Paulo
Brazil
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro
Brazil
Weill Cornell Chelsea CRS
New York, New York
United States of America
Bronx Prevention Center
Bronx, New York
United States of America
New Jersey Medical School Clinical Research Center CRS
Newark, New Jersey
United States of America
Washington University CRS
St. Louis, Missouri
United States of America
UIC Project WISH CRS
Chicago, Illinois
United States of America
Ponce de Leon
Atlanta, Georgia
United States of America
Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia
United States of America
University of Colorado - The Children's Hospital of Denver
Aurora, Colorado
United States of America
East Bay AIDS Center
San Francisco, California
United States of America
UCLA Vine Street Clinic
Los Angeles, California
United States of America
Alabama Vaccine CRS
Birmingham, Alabama
United States of America