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Reduced glycerin formulation of tenofovir vaginal gel safe for rectal use
Date:5/16/2012

researchers from CONRAD, a research organization which holds the rights to develop the gel, reformulated it with a reduced amount of glycerin, a common additive found in many gel-like products. In laboratory tests conducted by MTN researchers, the reformulated gel was three times less likely to cause cells in rectal tissue to release water, and equally effective against HIV as the vaginal formulation.

Data from an early phase clinical trial of the reduced glycerin gel presented in March 2012 at the 19th Conference on Retroviruses and Opportunistic Infections (CROI), suggested it was safe and acceptable in 65 HIV-negative men and women who used it rectally once a day for one week. Results from this study, called MTN-007, and future studies will have important implications for the development of a rectal microbicide that could help protect against HIV or other sexually transmitted infections during anal sex.

As follow-up to MTN-007, researchers are now planning a Phase II, multi-site trial called MTN-017 that will involve 186 men who have sex with men, and transgender women at clinical sites in Peru, South Africa, Thailand, and the U.S. Participants will cycle through three study regimens: reduced glycerin tenofovir gel used daily, reduced glycerin tenofovir gel used before and after anal sex, and daily use of the antiretroviral tablet Truvada. MTN-017 will allow researchers to collect additional information

In addition to Dr. Dezzutti, other authors of the study are Lisa Rohan, Ph.D., University of Pittsburgh; Lin Wang, M.D., Ph.D., Magee-Womens Research Institute ; Kevin Uranker, Magee-Womens Research Institute; Cory Shetler, Magee-Womens Research Institute; Marilyn Cost, Magee-Womens Research Institute; J.D. Lynam, Magee-Womens Research Institute; and David Friend, Ph.D., CONRAD, Arlington, Va.

Tenofovir gel contains the antiretroviral tenofovir, which is commonly used in the treatment of HIV. The vaginal formulation of teno
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Contact: Clare Collins
collcx@upmc.edu
412-641-7299
Microbicide Trials Network
Source:Eurekalert

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