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Primary Objective

  • Determine the genitourinary safety of dapivirine gel (0.05%) compared to matched placebo gel and universal placebo gel following seven once daily penile applications

Study Summary
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 seven 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 added valuable data to the development portfolio of dapivirine gel (0.05%) as a microbicide. The inclusion of a vehicle placebo arm (matched placebo gel) allowed for an assessment of 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 provided data regarding male tolerance of this widely used microbicide trial control.

MTN-012 completed follow-up on July 18, 2011. Results were first presented at the 2012 International Microbicides Conference held on April 15-18, 2012, in Sydney, Australia. The primary manuscript, the only paper from this study, was published in AIDS Research and Human Retroviruses on October 26, 2013.

Primary Results
Cumulatively, 13 adverse events (AEs) were reported (12 Grade 1 and 1 Grade 2).  A total of seven AEs were reported in the dapivirine 0.05% gel arm, 4/7 were judged to be related to study product. These included increased alanine aminotransferase, increased aspartate aminotransferase, application site paresthesia and inflamed sebaceous gland. The PK analysis resulted in detectable dapivirine levels in plasma of all participants who completed their final clinic visit (23 men), with geometric mean level of 343 pg/mL (95% confidence interval: 229-458 pg/mL). Acceptability of the product was high, with 72% of men reporting that they would be ‘very likely’ to use the gel in the future.

Protocol Chair(s)
Cranston, Ross (Protocol Chair)
Protocol Title
Male Tolerance Study of Dapivirine Gel Following Multiple Topical Penile Exposures
DAIDS Protocol ID
Study Focus/Product Administration
Study Type
Study Phase
Phase I  
United States
Men (cisgender men, non‐transgender men)   
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US National Institute of Mental Health
US National Institutes of Health
International Partnership for Microbicides