- About UsOur Story, Our Team & Support Information
- What We DoAdvocacy to Achieve the End of AIDS
- Advance HIV/SRH Integration
- Advocate for Access to High-Impact Prevention
- Improve Research Conduct
- Product Innovation & Availability
- Promote Effective HIV Prevention Policy
- Strengthen Global Advocacy Networks
- Track and Translate the Field
- Our FocusInterventions to End the Epidemic
- ResourcesPublications, Infographics, Events & More
- MediaInformation & Resources for the Press
- Our BlogPrevention News & Perspective
Status
Completed
Phase
Open Label
Principal Investigator(s)
Robert M Grant
Objective
Continuation of the iPrEx study designed to provide additional information about the safety of PrEP and the behavior of people taking PrEP over a longer term. iPrEx OLE was fully enrolled in July 2012 and every participant is being followed for 72 weeks.
Key results: Enrollment in OLE was greater for non-condom users, those practicing recreational anal intercourse, those with herpes or syphilis. There was no difference in PrEP update by age, education, transgender identity, prior randomized group, or substance use (measured: alcohol, methamphetamine, cocaine). HIV incidence on PrEP in OLE was 1) 49% lower than off PrEP after adjusting for baseline sexual risk, 2) 53% lower than during the placebo arm of the randomized phase, 3) 51% lower than during the gap in study phases. Adherence was good, not perfect. Those who stayed on 2-3 tablets/ week experienced 84% risk reduction, while those who adhered to greater than 4/ week experienced 100% risk reduction.
Last updated August 9, 2022
Prevention Option(s)
PrEP
Observational
Prospective Cohort
Longitudinal
Arms and Assigned Interventions
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
Official Code
Related Publications
Trial Sponsors
DAIDS/NIH, through a grant to the Gladstone Institutes
Product Developers
Gilead
July 2011
April 2014
Date of Enrollment Completion
July 1, 2012
Enrollment
1 770
18
Years
Population
MSM
Sites
Investigaciones Medicas en Salud (INMENSA)
Lima
Peru
Asociación Civil Selva Amazónica (ACSA)
Iquitos
Peru
San Francisco Department of Public Health
San Francisco, California
United States of America
Fenway Community Health Clinical Research Site (FCHCRS)
Boston, Massachusetts
United States of America
Ruth M Rothstein CORE Center
Chicago
United States of America
Universidade de São Paulo
Sao Paulo
Brazil
Instituto de Pesquisa Clínica Evandro Chagas
Rio de Janeiro
Brazil
Universidade Federal do Rio de Janeiro
Rio de Janeiro
Brazil
Research Institute for the Health Sciences
Chiang Mai
Thailand
Emavundleni Desmond Tutu HIV Centre CRS
Cape Town
South Africa
Fundación Ecuatoriana Equidad
Guayaquil
Ecuador