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iPrEx, or Pre-Exposure Prophylaxis Initiative is a clinical trial aimed at determining whether two antiretroviral (ARV) medications used to treat HIV/AIDS help prevent HIV acquisition in HIV-uninfected people at high risk of HIV infection.
Titled "Chemoprophylaxis for HIV Prevention in Men," the study will determine whether the combination of tenofovir (TDF) and emtricitabine (FTC) in one tablet called Truvada®, taken once a day, is safe and effective in preventing HIV infection in men who have sex with men (MSM) at high risk.
This is not a new idea. Other Pre-Exposure Prophylaxis (PrEP) studies are enrolling different populations at high risk in the United States of America, Botswana, Uganda, Malawi, South Africa, Zambia, Zimbabwe, and Kenya.
| Ongoing and Planned PrEP Trials of August 20081 | |||||
| Location | Sponsor/ Funder |
Population (mode of exposure) | Intervention arms | PrEP strategy(ies) being tested | Status / Expected completion |
| United States | CDC | 400 gay men and other men who have sex with men (penile/rectal) | 1 | TDF | Fully enrolled - Ongoing / 2009 |
| Thailand | CDC | 2,400 injecting drug users (parenteral) | 1 | TDF | Enrolling / 2009 |
| Botswana | CDC | 1,200 heterosexual men and women (penile and vaginal) | 1 | TDF/FTC (switched from TDF Q1 2007) | Enrolling / 2010 |
| Brazil, Ecuador, Peru, US, additional sites TBD (iPrEX Study) | NIH, BMGF | 3,000 gay men and other men who have sex with men (penile/rectal) | 1 | TDF/FTC | Enrolling / 2010 |
| Kenya, Uganda (Partners PrEP Study) | BMGF | 3,900 serodiscordant heterosexual couples (penile and vaginal) | 2 | TDF; TDF/FTC | Planning / 2012 Anticipated start Q3/2008 |
| Kenya, Malawi, South Africa, Tanzania (FEMPrEP) | FHI, USAID | 3,900 high-risk women (vaginal) | 1 | TDF/FTC | Planning / 2011 Anticipated start Q3/2008 |
| Southern Africa; specific sites TBD (VOICE Study) | MTN, NIH | 4,200 sexually active women (vaginal) | 3 | TDF; TDF/FTC; TDF gel | Planning / 2012 Anticipated start Q1/2009 |
| BMGF—Bill & Melinda Gates Foundation; CDC—US Centers for Disease Control; FHI—Family Health International; MTN—Microbicide Trials Network; NIH—US National Institutes of Health; USAID—United States Agency for International Development | |||||
| 1Anticipating the results of PrEP Trials, August 2008. AIDS Vaccine Advocacy Coalition—AVAC | |||||
A study that took place in West Africa between June 2004 and March 2006, and used tenofovir (TDF), one of the ARV medications used in the iPrEx study, enrolled 936 women in Ghana, Cameroon, and Nigeria. The study showed that the daily oral use of TDF did not increase the risk of serious adverse events in HIV-uninfected women.
ONUSIDA (the Joint United Nations Programme on HIV/AIDS) estimates that there are more than 4 million new infections per year despite widespread knowledge of the protective effects of abstinence, monogamy, and condom use. The main intervention used so far to prevent HIV transmission has been voluntary counseling and testing (VCT) and the promotion of condom use. The effectiveness of these interventions in reducing risky behavior has been demonstrated in some settings, but not in others, and the incidence of HIV remains high even in settings with policies that promote 100% condom use.
Men who have sex with men (MSM) are one of the groups most affected by the AIDS epidemic in some countries. Where information was collected, the prevalence of HIV infection is far higher in MSM than in the general population. The situation is worse in countries where the existence of MSM is denied or is a cause of discrimination. The result is a lack of prevention and care services designed specifically for MSM.
A recent article on HIV and MSM published in PlosMedicine in December of 2007 reports that MSM have a markedly greater risk of being infected with HIV than the general population in low- and middle- income countries in the Americas, Asia, and Africa, where MSM are in urgent need of prevention and care.
Global iPrEx is the first large efficacy study to evaluate the use of PrEP in MSM in Africa, Asia, and North and South America.
iPrEx, the PrEP Initiative, was the name selected by the community at the Andean study sites in Peru and Ecuador that were initially involved in this study, after a broad consultation. After two and a half years of preparatory work, the "Chemoprophylaxis for HIV Prevention in Men" study initiated operations in Lima on June 18, 2007. The first participant was enrolled on July 19, 2007.
Science Policy Forum: Promote HIV Chemoprophylaxis Research, Don't Prevent It
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