MTN-012/IPM 010 was a Phase 1 male tolerance trial that studied the safety of dapivirine gel (0.05%), among 48 (24 circumcised and 24 uncircumcised) sexually abstinent, HIV-negative males. Each participant was asked to apply study gel to his penis prior to his longest period of rest for 7 consecutive days. The pre-filled applicators contained dapivirine 0.05% gel, a matched placebo gel, or the universal HEC placebo gel. This study was conducted to determine if dapivirine 0.05% gel was safe and well-tolerated by circumcised and uncircumcised men.
This Phase 1 trial will add valuable data to the development portfolio of dapivirine gel (0.05%) as a microbicide. The inclusion of a vehicle placebo arm (matched placebo gel) will help understand whether any adverse events are associated with the gel formulation (as opposed to the active ingredient in the gel). The inclusion of a HEC placebo gel arm will provide data regarding male tolerance of this widely used microbicide trial control. Preliminary results were presented at the Microbicides 2012 Conference.
US National Institute of Mental Health
US National Institutes of Health