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HIV prevention researchers to compare common ARV as a pill and vaginal gel in unique study
Date:7/9/2008

PITTSBURGH, July 9 , 2008 In battle with an epidemic that has outpaced nearly all efforts to contain it, researchers are turning to strategies centered on the same antiretroviral (ARV) drugs that have been used successfully to treat HIV in hopes they will be as effective a stronghold for preventing the virus. For women, who make up nearly half of the 33 million people living with HIV/AIDS worldwide, the ARV tenofovir has particular promise because it can be formulated as either an oral tablet or a vaginal gel to be used daily. But ARV-based prevention approaches are not without scientific and practical challenges. The Microbicide Trials Network (MTN) is taking aim at among the most pressing of these challenges in the first clinical trial to directly compare the tablet and vaginal gel formulations of tenofovir.

In part because certain cells in the vagina are easy targets for the virus, women are more than twice as likely as their male partners to acquire HIV through sexual intercourse. As such, the clinical study, known as MTN-001, seeks to understand how each formulation of tenofovir works in these infection-prone cells, information that will help researchers determine the optimal doses needed to achieve drug concentrations most likely to prevent HIV in women.

MTN-001 also looks to understand the factors that influence women's preferences for one daily approach over another, because not even the best approach will be effective if women don't use it.

MTN-001 is a Phase II study designed to evaluate women's adherence to and acceptance of three daily regimens of tenofovir tenofovir gel, tenofovir disoproxil fumarate tablets and the two together and the pharmacokinetics, or how the drug is absorbed by and distributed in the body over time, of each regimen. The study will enroll 144 sexually active HIV-negative women who will follow all three regimens, each for six weeks with one week between when no study product is used. In the Unite
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Contact: Lisa Rossi
rossil@upmc.edu
412-916-3315
Microbicide Trials Network
Source:Eurekalert

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