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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.

Protocol Chair(s)
Cranston, Ross (Protocol Chair)
Protocol Title
Male Tolerance Study of Dapivirine Gel Following Multiple Topical Penile Exposures
DAIDS Protocol ID
11771
Status
Participants off Study and Primary Analysis Completed
Formulation
Gel
Drug
Dapivirine
Study Focus/Product Administration
Penis
Study Type
Safety
Study Phase
Phase I  
Countries
United States
Population
Men (cisgender men, non‐transgender men)   
Funder(s)
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US National Institute of Mental Health
US National Institutes of Health
Sponsor(s)
International Partnership for Microbicides