Preparing for efficacy trials of vaginal microbicides in Indian women.

ABSTRACT

Vaginal microbicides are topical compounds that are expected to protect women against vaginal transmission of HIV and other sexually transmitted pathogens. A large number of compounds are being evaluated as possible microbicides. Considering the spread of the HIV epidemic among women in India, clinical trials on microbicides starting from the Phase I safety and acceptability studies to Phase III efficacy trials are important. Conducting efficacy trials is a major endeavour and this review discusses challenges and issues and the preparatory steps to make such efficacy trials possible in India.