Researchers at the University of Alabama (UAB) and the University of Pittsburgh School of Medicine say an experimental anti-HIV gel being tested in Phase II trial studies is safe for women to use on a daily basis. The gel, called tenofovir, was successfully applied by non-HIV infected women patients, daily, over 6 months, as a prevention for HIV infection. The drug is being tested in trials conducted under the authority of a consortium of researchers, exploring and evaluating anti-HIV microbicides. The researchers are a part of the U.S. National Institutes of Health-funded Microbicide Trials Network.
200 sexually active HIV-negative women were included in the study. Participants were age 19 to 50, and 64 percent were married. The goal was to determine the drug's safety if used daily, and the woman's willingness to apply it according to directions.
Results from the tenofovir study comes as welcome news to this segment of the HIV/AIDs prevention research community, following on the heels of unsuccessful late-stage trial testing of other drugs, including another gel, carraguard, (which our blogger Sean Philpott had blogged about earlier this month) which failed to prevent HIV infection in 6,000 South African women tested. That study ended in 134 new HIV infections in the carraguard group, and 151 new infections in the placebo group. A year ago, two other late-stage drug trials for similar preventative gels were stopped due to fears the drugs would accelerate a women's chances of infection instead of decreasing it. Researchers acknowledged that low use of the gel by participants may have played a role in adversely affecting the results.
In South Africa, some 8,000 women develop HIV infection each day.
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