CAPRISA 004 included 889 sexually active HIV-seronegative women in South Africa at high risk of HIV infection. 843 women completed the study.
HIV infection is a significant problem in South Africa. In a study in the provincial town of 21.3% of pregnant 17-18 year old girls were HIV-positive. Among 23-24 year olds HIV was detected in 51.1%.
The study was found that the use of microbicides gel reduces the risk of HIV-infection, 39%. Women using the gel in 80% of sexual contacts, 54 percent had a lower risk of infection. The protection of tenofovir decreased significantly with decreasing frequency of use - 28% reduction in use in 50-80% of sexual contacts.
Among the infected women were not isolated strains resistant to tenofovir. The gel had no effect on viral load of infected participants.
Vaginal gel was associated with reduced incidence of new HSV-2 infection by about 50%.
Women with HSV-2 infection had a significantly increased risk of HIV infection compared to HSV-2 seronegative. The use of tenofovir gel was associated with a reduction in the risk equally in both groups.
There was no significant difference in the incidence of side effects between active and placebo groups. Was reported slightly increased incidence of diarrhea in drug tenofovir gel, but no renal toxicity or hepatic adverse effects in individuals with hepatitis C.
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