The first-ever study of dapivirine gel as a rectal microbicide has begun.
MTN has launched the first study of dapivirine gel as a rectal microbicide. The study, MTN-026, is a Phase I study evaluating whether a gel formulation of the antiretroviral dapivirine is safe for use in the rectum. It will include approximately 27 cisgender and transgender men and women at two sites in the U.S. (Pittsburgh, Pennsylvania and Birmingham, Alabama) and in Bangkok, Thailand. The study will also evaluate the drug concentration in blood, rectal fluid and tissue, and explore the gel’s general acceptability. Results of MTN-026 will help determine whether further testing can be conducted on the safety and acceptability of dapivirine gel, and eventually, its effectiveness as a potential rectal microbicide to prevent HIV through anal sex.