CAPRISA 004

CAPRISA 004 is the name of a clinical trial conducted by CAPRISA. This particular study was the first to show that a topical gel could reduce a person's risk of contracting HIV. The gel used in the study contained a microbicide.

A previous study had measured the safety and tolerability of tenofovir in both sexually active and abstinent women. This study gave support to the idea that tenofovir was a drug which was worth examining as an HIV preventative.

CAPRISA 004 was a phase IIb, double-blind, randomized, placebo-controlled study comparing 1% tenofovir gel with a placebo gel. 900 young women who were judged to be at risk of contracting HIV volunteered to use a study gel in their vaginas, with half of those receiving the microbicide gel and the other half getting the placebo (according their randomization results). The study asked participants to apply a first dose of the gel within 12 hours before having sex and to apply another dose within 12 hours after sex. All study volunteers participated in HIV risk reduction counseling and received condoms. The study assisted in arranging treatment for any sexually transmitted infections that participants contracted.

The study began in May 2007, was completed in December 2009, and the data collected was published in March 2010. The study design had expected the study to last for 30 months, with about 14 months to recruit study volunteers then with follow-up until 92 participants were observed to have become infected with HIV. The entrance criteria was such that, based on risk factors in the participants' lifestyles, the study expected 92 infections to occur approximately 16 months after they recruited the final volunteer.

Researchers led by Quarraisha Karim found that a microbicide containing 1% tenofovir was, for women participating in the trial, 39% effective in reducing risk of contracting HIV during sex and 51% effective in preventing genital herpes infections.

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