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International Rectal Microbicide Advocates cheers launch of world's third rectal microbicide trial
Date:10/13/2010

crobicides. Tenofovir gel, for example, is a candidate microbicide specifically developed to prevent vaginal transmission of HIV. In a recent study known as CAPRISA 004, tenofovir gel was found to significantly reduce the risk of HIV among at-risk women who were instructed to use the gel before and after vaginal intercourse. In an ongoing, large-scale effectiveness trial called VOICE Vaginal and Oral Interventions to Control the Epidemic researchers from the U.S. National Institutes of Health-funded Microbicide Trials Network (MTN) are testing daily use of tenofovir gel in African women, with results expected in 2013.

This new Phase I rectal microbicide study, known as MTN-007, aims to determine if rectal use of tenofovir gel is safe, and in particular, does not cause cells in the rectum to become more vulnerable to HIV. Investigators will also ask trial participants questions regarding the gel's desirability. MTN-007 will enroll 60 men and women at the University of Pittsburgh, the University of Alabama at Birmingham, and Fenway Health in Boston. Leading the study is Ian McGowan, M.D., Ph.D., of the University of Pittsburgh, who is also co-principal investigator of the MTN and serves as Scientific Vice-Chair of IRMA.

Little is known about tenofovir gel used rectally, but science is advancing our understanding. Laboratory and animal studies involving rectal application of tenofovir gel have suggested it's safe for testing in humans. In fact, MTN researchers have just completed the first Phase I trial with eighteen participants, called RMP-02/MTN-006, in collaboration with the Microbicide Development Program at the University of California, Los Angeles. While results of RMP-02/MTN-006 are not expected until early 2011, researchers have already recommended modifications to the gel's formulation. MTN-007 is evaluating the new formulation, which still contains the same amount of active drug 1% percent tenofovir but has a lower concentration of g
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Contact: Jim Pickett
jpickett@aidschicago.org
773-600-6407
International Rectal Microbicide Advocates
Source:Eurekalert

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