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iPrEx

Status
Completed
Phase
III
Principal Investigator(s)
Robert M. Grant, MD, MPH
Objective

Determine whether daily oral TDF/FTC can reduce the risk of HIV infection in men who have sex men and transgender who also receive HIV counselling, condoms, and treatment for other STIs.

Prevention Option(s)
PrEP
Study Design
Controlled
Randomized
Double-blind
Arms and Assigned Interventions
Description
Daily dosing
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Description
Daily dosing
Mode of Delivery
Tablet
ARMs
Placebo Comparator
Trial Sponsors
Bill & Melinda Gates Foundation, NIAID
Product Developers
Gilead Sciences, Inc.
June 2007
February 2014
Enrollment
2 499
18
Years
Population
MSM
Sites

San Francisco Department of Public Health

San Francisco, California
United States of America

Stroger Hospital and the CORE Center

Chicago, Illinois
United States of America

Fenway Community Health Clinical Research Site (FCHCRS)

Boston, Massachusetts
United States of America

Projeto Praca Onze, Universidade Federal do Rio de Janeiro

Rio de Janeiro
Brazil

IPEC/FIOCRUZ

Sao Paulo
Brazil

Universidade de São Paulo

Sao Paulo
Brazil

Fundación Ecuatoriana Equidad

Guayaquil
Ecuador

Asociación Civil Selva Amazónica (ACSA)

Iquitos
Peru

Asociación Civil Impacta Salud y Educación

Lima
Peru

Desmond Tutu Clinical Research Center

Cape Town, South Africa
South Africa

Research Institute for Health Sciences, Chiang Mai University

Chiang Mai
Thailand