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HPTN 083

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
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