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Blow to AIDS Prevention as Gel Trial Fails
February 19, 2008 at 12:26 PM
AIDS/HIV News
Carraguard, a candidate microbicide produced by the Population Council that had spent three years in large-scale 'Phase 3' trials, was unable to prevent transmission of the AIDS virus, the investigators said.
But the gel was found to be safe for long-term vaginal use, a finding they described as extremely promising.
'This is the first phase 3 microbicide efficacy trial to be completed with no safety concerns,' said prinicipal investigator Khatija Ahmed. '(...) However, the study was unable to show Carraguard's efficacy in preventing male-to-female transmission of HIV.'
The trial ran from March 2004 to March 2007 at three sites in South Africa among 6,262 women.
Half of the volunteers were given the Carraguard gel and condoms, while the other half were given a placebo gel and condoms. All were given HIV education and safer-sex counselling.
In the Carraguard group, 134 new HIV infections occurred, slightly fewer than the 151 in the placebo group. But Ahmed said the difference was not statistically significant and did not constitute evidence that Carraguard was effective.
It is the third major setback in the seven-year-long drive to develop a vaginal microbicide, the term for a cream that would block or kill the AIDS virus during vaginal intercourse.
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