For immediate release
Wednesday, 13 July, 2011
Media Contact
Dion Benetatos
Desmond Tutu HIV Foundation
Email: Dion.Benetatos@hiv-research.org.za
Phone: 079.219.1534
( CAPE TOWN, South Africa ) -- The iPrEx Open-Label Extension Study (iPrEx OLE), the next phase of the first human study to report efficacy results on pre-exposure prophylaxis (PrEP) to prevent HIV infection, is underway at clinical trial sites around the world including at the
Desmond Tutu HIV Foundation in Cape Town. Approximately 2,000 men and transgender women who have sex with men are expected to participate in the 72-week iPrEx OLE study
( http://www.iprexole.com/ ).Study sites in the United States and South Africa are enrolling participants now, as other study sites finalize the regulatory approval process.
In PrEP, antiretroviral medications that are usually used to treat HIV are taken by uninfected people to reduce their risk of infection. The iPrEx study found that men and transgender women who have sex with men (MSM) who took a single daily tablet containing the HIV medicationsemtricitabine and tenofovir (FTC/TDF), known commercially as Truvada®, experienced an average of 44% fewer HIV infections than those who received a placebo(blank pill).Participants whose self-reported adherence to daily PrEPwas higher achieved reductions in
HIV risk of more that 70%.The HIV risk reduction benefits of PrEP were in addition to those provided by safer sex counseling, condoms, HIV testing and the detection and treatment of sexually transmitted infections. iPrEx study results were published in the New England Journal of Medicine in November, 2010 (http://www.nejm.org/doi/full/10.1056/NEJMoa1011205). iPrEx OLEis a continuation of the iPrEx study that will collect additional data on PrEP efficacy, safety and adherence. All HIV-negative participants who took part in the original iPrEx study and who wishto participatewill receive FTC/TDF for HIV prevention for 72 weeks through iPrEx
OLE.No placebo will be used in the Open Label Extension.
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“We are in a critical moment in HIV prevention research,” said iPrEx Protocol Chair Robert
Grant, MD, MPH of the Gladstone Institutes and the University of California at San
Francisco.“iPrEx provided the first proof of an important new method of HIV prevention that can help slow the global toll of 2.6 million new HIV infections each year. Developing and deploying new HIV prevention methods for men who have sex with men, who are at greatly increased risk of HIV infection, will be key to slowing the global epidemic. iPrEx OLE will give us new insight on how to best use PrEP safely and effectively to reduce HIV infections and keep individuals and communities healthy.”
In addition to collecting longer-term data on PrEP efficacy and safety, iPrEx OLE will provide important additional information about whether study participants are able to use PrEP more consistently now that its HIV prevention benefit has been demonstrated and participants know they are receiving active drug. As with the original iPrEx study, iPrEx OLE participants will receive a comprehensive package of HIV prevention tools in addition to PrEP, including HIV testing, condoms, counseling and diagnosis and treatment of sexually transmitted infections.Some iPrEx OLE trial sites started enrolling participants in June, and all sites are expected tobe fully operational by August 2011. One additional study site, in Chicago, USA, will be added to the sites that participated in the original iPrEx study.The iPrEx OLE study sites are:

San Francisco Department of Public Health (San Francisco, USA)

Fenway Health (Boston, USA)

CORE Center Chicago (Chicago, USA)

The Desmond Tutu HIV Foundation (Cape Town, South Africa)

Instituto de Pesquisa Clinica Evandro Chagas (Rio de Janeiro, Brazil)

Universidade Federal do Rio de Janeiro (Rio de Janeiro, Brazil)
 Universidade de São Paulo (São Paulo, Brazil)
 Fundación Ecuatoriana Equidad (Guayaquil, Ecuador)
 Investigaciones Médicas en Salud (INMENSA) (Lima, Peru)
 Asociación Civil Selva Amazónica (ACSA) (Iquitos, Peru)

Research Institute for Health Science (Chiang Mai, Thailand) iPrEx OLE is one of several clinical trials of PrEP currently underway in different communities atrisk, including heterosexual couples and injecting drug users. Those studies are expected to report their findings in the coming one to three years. More information about PrEP and current
PrEP researchis available from AVAC: Global Advocacy for HIV Prevention at http://www.avac.org/ht/a/GetDocumentAction/i/3302 .
About DTHF
The Desmond Tutu HIV Foundation (DTHF) is a registered non-profit organisation focused on the pursuit of excellence in research, treatment, training and prevention of HIV and related infections. The DTHF operates community sites throughout greater Cape Town, South Africa, providing treatment, testing, and outreach services to at-risk communities like men who have sex with men.
Run in association with the Desmond Tutu HIV Centre at the University of Cape Town's Institute of Infectious Disease and Molecular Medicine, DTHF has become a source of advice for medical practitioners, support for people seeking testing or treatment, and leadership in preventative education. With an experienced and dedicated team of over 150 doctors and field workers, the Desmond Tutu HIV Foundation offers a holistic approach to the HIV epidemic.
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About iPrEx OLE
The iPrEx study (Iniciativa Profilaxis Preexposicion or Preexposure Prophylaxis Initiative)
(http://www.iprexole.com), was a double-blind, placebo controlled Phase III clinical trial that began in 2007 following three years of community consultation. iPrEx was the first human efficacy study of PrEP to report data. Detailed information about the results of the iPrEx study is available at http://www.iprexnews.com/studyresults/english.html
. iPrEx was sponsored by the
U.S. National Institutes of Health (NIH) through a grant to the Gladstone Institutes, a non-profit independent research organization affiliated with the University of California at San Francisco.
Additional support for the study was provided by the Bill & Melinda Gates Foundation. iPrEx OLE (Open Label Extension) is a continuation of the iPrEx study designed to provide extendedsafety and efficacyinformation on PrEP and additional data on the behavior of people taking PrEP over a longer term. The study is sponsored by the Division of AIDS (DAIDS) of the
U. S. National Institutes of Health (NIH) through a grant to the Gladstone Institutes in San
Francisco California. Gilead Sciences donates drug for iPrEx OLE but does not participate in the design, conduct or analysis of the study.
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