Clinical Research
In 2016, a vaginal ring containing the antiretroviral drug dapivirine became the first microbicide product to be shown effective against HIV in two clinical trials. In those trials, known as ASPIRE and The Ring Study, rates of HIV protection were higher among women older than 21, who tended to use the rings more consistently. Two open-label extension studies of the monthly dapivirine ring also yielded promising results, and the International Partnership for Microbicides is pursuing global and national regulatory approval to license the product in countries where women face the highest risk of acquiring HIV.
Other clinical trials continue to explore the safety and effectiveness of various vaginal and rectal microbicide candidates. This section contains resource materials that highlight recent clinical research on microbicides.
The design and conduct of a single microbicide clinical trial is a sophisticated undertaking that may involve several countries, dozens of scientists and staff members, and thousands of research participants. Readers will find resources that can help them understand the scope and complexity of these trials, including information on ethical considerations, participant safety, community engagement, potential drug resistance, and HIV prevention and care for study participants.