Rationale: The rationale for all microbicide trials is to evaluate potential products that could be used vaginally or rectally to help reduce the risk of HIV infection via sexual exposure in the user. These candidates could be formulated in many ways including as gels, suppositories, creams, and vaginal rings. In laboratory studies, cellulose sulfate (CS) blocked binding sites that HIV uses to enter and infect cells, thereby preventing HIV from establishing infection.
Study Questions: The study was designed to assess the impact of correct and consistent CS use on rates of HIV infection and infection with other sexually transmitted infections among HIV-negative, sexually active women.
Participants: 2,160 HIV-negative women
Country: Nigeria
Trial sponsors and collaborators: CONRAD, Family Health International, United States Agency for International Development (USAID)
When were results released? The trial stopped early (January 2007) following announcement of data from CONRAD's trial of CS. In the data gathered to-date, there is no evidence of safety concerns or of effectiveness. Results were announced July 2007.
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