Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk Women

PHASE2CompletedINTERVENTIONAL
Enrollment

594

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

November 30, 2015

Study Completion Date

November 30, 2015

Conditions
HIV Infection
Interventions
DRUG

Maraviroc

300-mg tablet, once daily, from Week 0 through Week 48

DRUG

Emtricitabine

200-mg capsule, once daily, from Week 0 through Week 48

DRUG

Tenofovir disoproxil fumarate

300-mg tablet, once daily, from Week 0 through Week 48

OTHER

Maraviroc placebo

Once daily from Week 0 through Week 48

OTHER

Emtricitabine placebo

Once daily from Week 0 through Week 48

OTHER

Tenofovir disoproxil fumarate placebo

Once daily from Week 0 through Week 48

Trial Locations (13)

10010

Weill Cornell Chelsea CRS, New York

15213

University of Pittsburgh CRS, Pittsburgh

19104

Penn Therapeutics, CRS, Philadelphia

20006

George Washington Univ. CRS, Washington D.C.

21205

Johns Hopkins University CRS, Baltimore

27599

Chapel Hill CRS, Chapel Hill

44106

Case Clinical Research Site, Cleveland

90035

UCLA CARE Center CRS, Los Angeles

94143

Bridge HIV CRS, San Francisco

02215-4302

Fenway Health (FH) CRS, Boston

07103

New Jersey Medical School Clinical Research Center CRS, Newark

98104-9929

University of Washington AIDS CRS, Seattle

00935

Puerto Rico AIDS Clinical Trials Unit CRS, San Juan

All Listed Sponsors
collaborator

HIV Prevention Trials Network

NETWORK

collaborator

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NETWORK

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT01505114 - Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk Women | Biotech Hunter | Biotech Hunter