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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.

Key result: 44% reduction in HIV infection rate among MSM across 11 sites in US, South America, Africa, and Thailand

Last update August 9, 2022

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
Results
Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men
Official Code
NCT00458393
Related Publications
Adherence support approaches in biomedical HIV prevention trials: experiences, insights and future directions from four multisite prevention trials.
Baseline Characteristics Explain Differences in Effectiveness of Randomization to Daily Oral TDF/FTC PrEP Between Transgender Women and Cisgender Men Who Have Sex With Men in the iPrEx Trial
Metabolic Effects of Preexposure Prophylaxis With Coformulated Tenofovir Disoproxil Fumarate and Emtricitabine
Patterns and correlates of PrEP drug detection among MSM and transgender women in the Global iPrEx Study
Similar Trials
iPrEx OLE
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