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ECLAIR

Status
Completed
Phase
II
Objective

To evaluate the safety and tolerability of the injectable agent in HIV uninfected men. 

 

*Results presented at the 2016 Conference on Retroviruses and Opportunisitic Infections (CROI) 2016 suggest injections every 8 weeks rather than every 12, as in this trial, may be optimal. Study participants preferred injections to once-daily tablets.*

 

Prevention Option(s)
PrEP
Study Design
Controlled
Placebo
Randomized
Blind
Arms and Assigned Interventions
Description
Injections (800 mg) 3 times over 12 weeks
Mode of Delivery
Intramuscular
Products
Cabotegravir (GSK 744)
ARMs
Experimental
Description
GSK 744 (cabotegravir) placebo injection
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Description
Oral phase: 30mg tablet daily for 4 weeks followed by a 1 week washout. Participants will then be transferred to injection phase.
Mode of Delivery
Tablet
Products
GSK 744
ARMs
Experimental
Description
Oral phase placebo
Mode of Delivery
Tablet
ARMs
Placebo Comparator
Official Code
NCT02076178
Trial Sponsors
ViiV Healthcare
Product Developers
GlaxoSmithKline
March 2014
March 2016
Enrollment
127
18
Years
65
Years
Population
Men
Sites

GSK Investigational Site- California

San Francisco
United States of America

GSK Investigational Site - District of Columbia

Washington, District of Columbia
United States of America

GSK Investigational Site- Georgia

United States of America

GSK Investigational Site - Massachusetts

Boston, Massachusetts
United States of America

GSK Investigational Site - New Mexico

Santa Fe, New Mexico
United States of America

GSK Investigational Site - New York

New York, New York
United States of America

GSK Investigational Site - Pennsylvania

Philadelphia, Pennsylvania
United States of America

GSK Investigational Site - Virginia

Newport News, Virginia
United States of America