Passing.
uninfected women had little incentive to protect themselves with anti-HIV drugs in pills or vaginal gel.
Microbicides Trials Network
ATLANTA a large study of a biomedical intervention that potentially offers new options for women to protect themselves against HIV infection, to the surprise of many researchers failed. But the results say more about the behavior of participants in the efficacy of the products tested.
At the 20th Conference on Retroviruses and Opportunistic Infections held here March 3-6, infectious disease specialist Jeanne Marrazzo, University of Washington, Seattle, reported the disappointing results of the study known VOICE name, which means vaginal and oral interventions to control the epidemic. As explained Marrazzo, VOICE began in September 09 and ended in August 2012, the 5029 inscription women in South Africa, Uganda and Zimbabwe. The study evaluated three different strategies for what is known as pre-exposure prophylaxis, or PrEP, which aims to protect uninfected people by giving them anti-HIV drugs every day either orally or vaginally. In one approach, the women took a pill containing the antiretroviral drugs tenofovir and emtricitabine. A second arm VOICE tested alone tenofovir pills, while women in the third arm received a vaginal gel containing tenofovir. Other trial participants were given an inert gel or dummy pills.
A total of 312 women were infected with HIV during the study, and there was no statistically significant difference in infection rates between women who received placebos or PrEP. tenofovir gel and oral PrEP worked in other studies with women. Marrazzo but emphasized that VOICE participants simply do not use the product as directed. "By several measures the grip was disappointing," Marrazzo said.
Although researchers have attempted to monitor compliance during the study by asking women to report the usage and return the pills or gel applicators used each month, which proved to distort the bad reality. Women reported using PrEP 0% of the time, and their unused yields seemed confirm the figure. But when the researchers analyzed later, the drug levels in the blood of women, they found that over 30% had evidence of anti-HIV drugs in their bodies at each study visit. "There was a profound discrepancy between what they told us, that they brought, and what we've measured," said Marrazzo.
The sad reality, she said, is that the failure of VOICE says more about human nature that biomedical mechanisms at work. "We believe that all this time on these major interventions, and maybe people do not want to use from the get-go," said Marrazzo. "We need to start listening to people, and if you do not going to use it, we will not do a test. "
But virologist Robert Grant of the University of California, San Francisco, who led an extensive oral PrEP study who worked in men who have sex with men, said he suspected the real problem is the nature placebo-controlled study. the women, he said, would have more incentive to use PrEP if they knew they were receiving gel or pill that took drugs in them. "We need open label demonstration projects that give young women a chance to use PrEP if they know what it is," said Grant. he added that women may also have heard about the results of other PrEP studies that have worked. "In retrospect, how do you think people join a study drug when they think they already know the outcome."
Sharon Hillier, an infectious disease specialist at Reproductive University of Pittsburgh in Pennsylvania, heads the microbicide trials Network that depicts the trial and disagreed with Grant. "It's like the female condom, which probably 'works', but very few women want even when you give, "said Hillier. "PrEP has a place and will be an effective strategy for some people, but if we really want to make a dent in this epidemic, we must pay attention to this high risk young women told us :. We like getting the services provided by your study but we do not want the products you try. "
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