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

enofovir gel are safe for women and their babies before they become widely available," he added.

Promising results from an earlier clinical study of tenofovir gel called CAPRISA 004 found 39 percent fewer infections among HIV-negative women who used it before and after vaginal sex compared to women who used a placebo gel. A major large-scale study being conducted by the MTN called VOICE -- Vaginal and Oral Interventions to Control the Epidemic, is currently testing whether daily use of the gel, or an antiretroviral (ARV) tablet, can reduce risk for HIV among 5,000 women in southern Africa. The U.S. Food and Drug Administration (FDA) has indicated it will consider approving tenofovir gel as an HIV prevention method for women based primarily on its review of the results of CAPRISA 004 and VOICE, which are expected in 2013.

The new study, MTN-008, will provide critical information about the safety of using tenofovir gel during pregnancy and lactation, which the FDA also considers essential to its decision whether to approve the gel. The study is part of a comprehensive research program at the MTN designed to take incremental steps toward determining whether tenofovir gel can safely and effectively protect women against HIV infection when they are pregnant or breastfeeding.

Tenofovir gel contains the same ARV drug that in oral tablet form is a mainstay of one of the most widely used regimens for treating HIV. Oral tenofovir is increasingly being used, along with other ARVs, to safely treat both pregnant and breastfeeding women who are HIV-positive. Research also has shown that HIV-positive pregnant women who are treated with oral tenofovir pass very little drug to their newborn infants.

MTN-008 is a follow-up study to MTN-002, which found that a single dose of tenofovir gel given to pregnant women hours before scheduled Cesarean delivery was safe and well-tolerated by both mother and infant, resulting in only trace amounts of a
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Contact: Clare Collins
collcx@upmc.edu
412-641-7299
Microbicide Trials Network
Source:Eurekalert

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