African HIV trial fails for the wrong reasons.
The study had such promise. HIV among young African women is still running rampant, and other research had shown that using either anti-retroviral tablets every day, or an anti-retrovirus gel before and/or after sex, was every effective at preventing the onset of AIDS. But when researchers looked at the results of a trial involving more than 5,000 women, they were shocked.
The daily dosages didn’t work. There was no difference between women who used the drugs and women in a placebo group (taking pills or gels that didn’t contain retroviral agents).
Vaginal and Oral Interventions to Control the Epidemic
The study, called VOICE (Vaginal and Oral Interventions to Control the Epidemic), began in 2009, and was headed by researchers at the University of Washington, in Seattle, and the University of Zimbabwe, in Harare. The study required 5,029 sexually active women in South Africa, Zimbabwe, and Uganda to use one of two approaches; taking an anti-retrovirus tablet every day, and using a vaginal anti-microbial containing an antiretroviral agent gel. The tablets were contained a drug called tenofovir (also known as Viread®), a tablet with tenofovir and another drug, called emtricitabine (Truvada®), and the gel was tenofovir.
Why did it fail?
So, what happened? Previous studies had shown that the drugs could reduce HIV infection by almost 40 percent. It turned out that the women didn’t use either the tablets or the gel every day. While they claimed to researchers that they were using the products, the research results showed that they really weren’t—the drugs were present in less than a third of blood samples taken from the women.
The study, if nothing else, underscored the need for researchers (and drug developers) to consider whether people will be willing to cooperate with a dosage-taking regimen while designing a treatment. Most clinical trials, in fact, take it for granted that participants willingly take the drug being tested. But here, human nature told a different story. But getting HIV prevention to women in Africa is crucial; women make up 60 percent of Africans with HIV, and are twice as likely to become infected with AIDS as their male partners.
The research project did show that the drugs were safe. Now, to find a way turn them into something women want to use.
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