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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.

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
September 2021
Enrollment
4 500
18
Years
Population
Transgender
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

Site(s) - Brazil

Brazil

Site(s) - Peru

Peru

Site(s) - India

India

Site(s) - Viet Nam

Vietnam

Site(s) - Thailand

Thailand

Site(s)-Argentina

Argentina

Site(s) - South Africa

South Africa