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iPrEx OLE

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)
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