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Anti-HIV gel being evaluated in pregnant and breastfeeding women
Date:6/20/2011

PITTSBURGH, June 20, 2011 -- Determining whether a promising HIV prevention gel is safe for women to use while they are pregnant or breastfeeding is the aim of a new clinical trial being conducted by the National Institutes of Health-funded Microbicide Trials Network (MTN). Researchers are hopeful that the study -- the first clinical trial of the vaginal microbicide tenofovir gel in breastfeeding women and only the second in pregnant women -- will bring them a step closer to developing a safe and effective HIV prevention product women can use throughout their lives.

The Phase I trial is underway at two U.S. sites -- Magee-Womens Hospital of the University of Pittsburgh Medical Center and the University of Alabama, Birmingham (UAB) -- but has implications for women throughout the globe. Indeed, nearly 16 million women are living with HIV worldwide, with most acquiring infection through unprotected vaginal sex. Microbicides, such as tenofovir gel, are products being developed to prevent HIV infection when used in the vagina or rectum. Researchers anticipate tenofovir gel may be the first vaginal microbicide approved for preventing HIV infection in women.

"Tenofovir gel and other vaginal microbicides under development are intended to be used by sexually active women -- the very women most likely to get pregnant -- yet we have very little information about whether these products are safe for them to use," said Richard Beigi, M.D., M.Sc., assistant professor of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh School of Medicine, who is leading the study.

"In fact, HIV prevention may be most critical during pregnancy due to heightened immune responses or hormonal changes that appear to make pregnant women twice as likely to be infected by sexual partners. Most women also continue to be sexually active and use medication while they are pregnant and breastfeeding, so we need to know if products like t
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Contact: Clare Collins
collcx@upmc.edu
412-641-7299
Microbicide Trials Network
Source:Eurekalert

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