iPrEx
The results of the iPrEx PrEP effectiveness
trial of once-daily TDF/FTC
(brand name Truvada) in gay men, transgender
women and other men who
have sex with men are a landmark in HIV
prevention research. The
results, released on November 23, 2010, showed
that once-daily TDF/FTC reduced
risk of HIV infection by an average of 43.8%.
The iPrEx trial is a Phase
III PrEP trial
that was designed to determine whether
once-daily TDF/FTC (brand name
Truvada)—a drug that is already being used to
treat people living with
HIV—can reduce the risk of HIV infection in
HIV-negative gay men and
other men who have sex with men.
The large-scale safety and effectiveness study, known as iPrEx or the pre-exposure prophylaxis initiative, enrolled its first participant in July 2007 and eventually enrolled 2,499 gay men and other men who have sex with men at sites in six countries—Brazil, Ecuador, Peru, South Africa, Thailand and the US. It was funded by the US National Institutes of Health and the Bill & Melinda Gates Foundation.
For information on the range of PrEP research ongoing visit the PrEP Resources page.
Planned iPrEx Follow-Up
The encouraging results of the iPrEx study calls for further research. An open label extension, or "rollover" of the iPrEx study, will provide all HIV-negative iPrEx participants who enroll in this phase with access to FTC/TDF for 72 weeks.
The main difference from the rollover study and the initial study is all participants will knowingly receive FTC/TDF PrEP with full information about the efficacy and safety of PrEP learned from in the original iPrEx study. Findings will be reported in early 2013.
For more information on the follow-up study, visit here (PDF).
Background on iPrEx
Statements on the Results
The large-scale safety and effectiveness study, known as iPrEx or the pre-exposure prophylaxis initiative, enrolled its first participant in July 2007 and eventually enrolled 2,499 gay men and other men who have sex with men at sites in six countries—Brazil, Ecuador, Peru, South Africa, Thailand and the US. It was funded by the US National Institutes of Health and the Bill & Melinda Gates Foundation.
For information on the range of PrEP research ongoing visit the PrEP Resources page.
- Article and editorial from New England Journal of Medicine
- Official iPrEx trial
website (includes
press release, FAQs and a range of fact
sheets)
- What PrEP is and What it is not: A basic, one-page sheet with key messages in simple language
- Frequently Asked Questions about PrEP and the iPrEx Trial: In-depth answers to questions about the iPrEx trial, what it found, what the data mean and what happens next
- AVAC statement on iPrEx results
- CDC Fact Sheet: Pre-Exposure Prophylaxis (PrEP) for HIV Prevention: Promoting Safe and Effective Use in the United States
Planned iPrEx Follow-Up
The encouraging results of the iPrEx study calls for further research. An open label extension, or "rollover" of the iPrEx study, will provide all HIV-negative iPrEx participants who enroll in this phase with access to FTC/TDF for 72 weeks.
The main difference from the rollover study and the initial study is all participants will knowingly receive FTC/TDF PrEP with full information about the efficacy and safety of PrEP learned from in the original iPrEx study. Findings will be reported in early 2013.
For more information on the follow-up study, visit here (PDF).
Background on iPrEx
- Advocates Briefing on iPrEx PrEP Trial Results - Webinar with Bob Grant, iPrEx Principal Investigator
- PrEP
in 2011 - A discussion of clinical
implications with Bob Grant, iPrEx Principal
Investigator
- All Eyes on Global iPrEx: An up-close look at the PrEP effectiveness study in MSM - Webinar with Pedro Goicochea, iPrEx Investigator and Communications and Community Relations Specialist
- Advances in
PrEP - Late-breaker abstracts
presented at CROI 2011
- More from
the iPrEx
team
Statements on the Results
- aidsmap
- amfAR, The Foundation for AIDS Research
- Centers for Disease Control and Prevention (US)
- Global
Campaign for
Microbicides
- Global Forum on MSM & HIV
- Global HIV Vaccine Enterprise
- Global Network of People Living with HIV (GNP+)
- FHI
- Harlem United
- HIVMA
- International Rectal Microbicide Advocates
- Microbicide Trials Network
- National
Alliance of State & Territorial AIDS
Directors (NASTAD)
- National Institute of Allergy and Infectious Diseases (NIAID)
- Project
Inform
- San
Francisco AIDS
Foundation's Judith D. Auerbach in BETA
- Treatment
Action
Campaign (TAC)
- Treatment
Action Group (TAG)