CAPRISA NEWS FLASH

The DSMB overseeing the CAPRISA 004 Phase 2B trial to assess the safety and effectiveness of tenofovir gel for prevention of HIV infection in women in South Africa conducted a regularly scheduled review of the study data available to date and identified no safety concerns to warrant stopping the trial. Therefore, the Board recommended that the trial continue in order to determine whether the use of the vaginal microbicide tenofovir gel can help prevent male-to-female sexual transmission of HIV.

The members of the DSMB arrived at this recommendation after reviewing the number of confirmed HIV cases and adverse events identified to date among participants receiving tenofovir gel and among those receiving a placebo gel identical to the study gel but containing no active ingredient. Since only the DSMB has access to the interim data relevant to assessment of the effectiveness of tenofovir gel, the trial team cannot draw any conclusions about that product's effectiveness at this time.

CAPRISA 004 is being conducted according to the highest international ethical standards, and the interests and safety of the women in the study are paramount. The study team has incorporated multiple layers of safety monitoring and reporting, and works actively to decrease participants' overall risk of HIV infection by providing free condoms, STI testing and treatment, and regular counseling on preventing HIV and other sexually transmitted infections.

Source: http://www.caprisa.org/