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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.
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
September 2021
Enrollment
4 500
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
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