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HPTN 069/ACTG 5305 (NEXT-PrEP)

Status
Completed
Phase
II
Principal Investigator(s)
Roy M. Gulick, MD, MPH
Objective

Designed to evaluate the safety and tolerability of four ARV regimens in preventing HIV infection in a population of men who have sex with men who may be at risk of getting HIV infection through sex, and women who may be at risk of HIV infection through sex. The four ARV regimens being evaluated are maraviroc (MVC), MVC plus emtricitabine (FTC), MVC plus tenofovir disoproxil fumarate (TDF), and TDF plus FTC.

Prevention Option(s)
PrEP
Study Design
Controlled
Randomized
Double-blind
Arms and Assigned Interventions
Description
MVC 300 mg plus FTC placebo and TDF placebo orally once daily
Mode of Delivery
Tablet
Products
Maraviroc
ARMs
Experimental
Description
MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily
Mode of Delivery
Tablet
Products
FTC
Maraviroc
ARMs
Experimental
Description
MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily
Mode of Delivery
Tablet
Products
Maraviroc
TDF
ARMs
Experimental
Description
MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily
Mode of Delivery
Tablet
Products
FTC
TDF
ARMs
Experimental
Results
Maraviroc, an oral drug used to treat HIV infection, is safe and well-tolerated when taken daily as pre-exposure prophylaxis (PrEP) by HIV-uninfected men who have sex with men
Official Code
NCT01505114
Related Publications
Safety and Tolerability of Maraviroc-Containing Regimens to Prevent HIV Infection in Women: A Phase 2 Randomized Tria
Trial Sponsors
ACTG, HPTN, NIAID
June 2012
November 2015
Enrollment
600
18
Years
Population
Women
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

Fenway Health (FH) CRS

Boston, Massachusetts
United States of America

Fenway Institute

Boston, Massachusetts
United States of America

New Jersey Medical School CRS (El-Sadr CTU)

Newark, New Jersey
United States of America

New Jersey Medical School Clinical Research Center CRS

Newark, New Jersey
United States of America

Weill Cornell Chelsea CRS

New York, New York
United States of America

Weill Cornell Uptown CRS

New York, New York
United States of America

Chapel Hill CRS

Chapel Hill, North Carolina
United States of America

Wake County Health and Human Services CRS

Raleigh, North Carolina
United States of America

Case CRS

Cleveland, Ohio
United States of America

Penn Therapeutics CRS

Philadelphia, Pennsylvania
United States of America

University of Pittsburgh CRS

Pittsburgh, Pennsylvania
United States of America

University of Washington AIDS CRS

Seattle, Washington
United States of America

Puerto Rico AIDS Clinical Trials Unit CRS

San Juan
Puerto Rico