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:Double-blind, Randomized
Arms and Assigned Interventions
Descriptionuniversal placebo, once daily (2.5g) for 7 days
Mode of DeliveryGel
ARMsPlacebo Comparator
Descriptiondosage: 0.05%, once daily (2.5g) for 7 days
Mode of DeliveryGel
ARMsExperimental
Results: A randomized male tolerance study of dapivirine gel following multiple topical penile exposures
Official Code:
NCT01277640
Trial Sponsors:
IPM, MTN, NIAID
Start Date
End Date
March 31, 2011
July 31, 2011
Enrollment:48
Age range:
18 Years ↔
any
Population:Cisgender Men