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New PRO2000 HIV-Prevention Findings Important Milestone on Path Toward Development of Effective Vaginal Microbicide
Date:2/9/2009

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To bolster these results additional trials must be run to generate confirming data. Fortunately, another study of PRO2000 (0.5 percent concentration) by the UK-based Microbicides Development Programme (MDP), a partnership of African and European researchers, is ongoing with results expected by the end of this year. The MDP study is taking place in South Africa, Tanzania, Uganda and Zambia.

Some important secondary data emerged from the HPTN 035 study. The study showed that HIV infection rates were the same in the placebo control arm and in the no gel arm, suggesting that women did not change their HIV risk behaviour when using a gel product, an important result that helps validate the safe introduction of microbicides into communities.

This trial and the others that have gone before it strengthen our resolve to continue with the important research needed to address the global AIDS epidemic. While IPM was not involved in the trial of PRO2000 and BufferGel, we strongly applaud and acknowledge with great respect the trial sponsors, researchers, staff and more than 3,000 study participants for their hard work, skill and commitment to improve women's health around the world.

This and other studies of early microbicide candidates in recent years have underscored the challenges we face in HIV prevention research and microbicide development. But they have also helped us map a path forward. The research community knows far more today about how to design and execute these complex clinical trials, and we are piloting novel trial designs with a sharper focus on participant adherence to increase the chance that the trial will generate the data needed for effective product development and licensure.

And as important as the PRO2000 data are in supporting the concept that a topical microbicide can prevent HIV infection, new products are needed that can increase the level of protection tha
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SOURCE The International Partnership for Microbicides
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