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Tenofovir gel provides high level of protection against HIV in rectal tissue
Date:2/28/2011

enofovir gel daily for one week compared to tissue from participants who used the placebo gel. While a slight anti-viral effect was noted in tissue from participants who received a single dose of tenofovir gel, the finding was not statistically significant. The single dose of oral tenofovir did not provide any protection against HIV in rectal tissue samples.

"These kinds of efforts early in the development phase of rectal microbicides can give us insight into a particular product's potential efficacy, which enables us to better design and hasten the pace of future clinical trials," said Dr. Anton.

According to self-reports, only 25 percent of men and women who had used the tenofovir gel said they liked it. However, when asked whether they would consider using the product in the future, 75 percent of these participants reported a high likelihood of future use. Two of the 12 participants who received tenofovir gel reported severe gastrointestinal side effects, including diarrhea and lower abdominal cramps.

"These results tell us that tenofovir gel was relatively safe to use in the rectum for most participants, but we need to address side effects to make it more acceptable to use," said Dr. Anton, who reported the findings at CROI. "Even though three-quarters of the participants reported they didn't like the gel, we are very encouraged that the majority would consider using such a product in the future."

Another study, MTN-007, now underway is using a formulation of tenofovir gel with less glycerin, a common additive found in many gel-like products, in the hope that this will make it better tolerated when used in the rectum. Laboratory tests of the reformulated gel suggest it is just as effective as the original formulation but less irritating to the epithelium the layer of cells that serves as a protective barrier inside the rectum. The study began in October 2010 and is enrolling 60 men and women at three sites University o
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Contact: Clare Collins
collcx@upmc.edu
412-770-8643
Microbicide Trials Network
Source:Eurekalert

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