Email Updates

You are here

MTN 012/IPM 010

Status
Completed
Phase
I
Principal Investigator(s)
Ross D. Cranston
Objective

The purpose of this study is to determine the safety of male genitalia when exposed to dapivirine gel following seven once daily applications.

 

Results: All gel products in this study were well tolerated with low frequency of Grade 1 genitourinary AEs reported that were similar in nature and frequency to those reported in other penile tolerance studies of both antiretroviral and nonantiretroviral drugs.  
Prevention Option(s)
Microbicides
Study Design
Randomized
Double-blind
Arms and Assigned Interventions
Description
matched placebo, once daily (2.5g) for 7 days
Mode of Delivery
Gel
ARMs
Placebo Comparator
Description
universal placebo, once daily (2.5g) for 7 days
Mode of Delivery
Gel
Products
HEC gel
ARMs
Placebo Comparator
Description
dosage: 0.05%, once daily (2.5g) for 7 days
Mode of Delivery
Gel
Products
dapivirine gel
ARMs
Experimental
Trial Sponsors
International Partnership for Microbicides, Inc, NIAID, MTN
March 2011
July 2011
Enrollment
48
18
Years
Population
Men
Sites

University of Alabama at Birmingham

Birmingham, Alabama
United States of America

University of Pittsburgh CRS

Pittsburgh, Pennsylvania
United States of America