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HPTN 077

Status
Completed
Phase
II
Principal Investigator(s)
Raphael J. Landovitz
Objective

Evaluate the safety, tolerability, and pharmacokinetics (which is how the body interacts with drugs) of an investigational, injectable HIV medicine (GSK1265744) in healthy, HIV-uninfected adults. 

Prevention Option(s)
PrEP
Study Design
Controlled
Randomized
Double-blind
Arms and Assigned Interventions
Description
One GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744 at Weeks 5, 17, and 29.
Mode of Delivery
Intramuscular
Tablet
Products
Cabotegravir (GSK 744)
ARMs
Experimental
Description
Participants will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo at Weeks 5, 17, and 29.
Mode of Delivery
Intramuscular
Tablet
ARMs
Placebo Comparator
Official Code
NCT02178800
Trial Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
February 2015
July 2017
Enrollment
176
18
Years
65
Years
Population
Women
Men
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

Chapel Hill CRS

Chapel Hill, North Carolina
United States of America

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS

Rio de Janeiro
Brazil

Malawi CRS

Malawi

Soweto HPTN CRS

Johannesburg, Gauteng
South Africa

CAPRISA Vulindlela Clinical Research Site

Pietermaritzburg, KwaZulu-Natal
South Africa