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MTN 033

Status
Completed
Phase
I
Principal Investigator(s)
Ken Ho, MD
Objective

MTN-033/IPM 044 is a Phase 1, randomized, open label, single-site trial designed to evaluate the pharmacokinetics of dapivirine gel (0.05%) when administered rectally via HTI vaginal applicator and a coital simulation device to healthy, HIV-1 uninfected men and transgender women. 

*Study is closed to follow-up*

 

Last updated May 9, 2021

Prevention Option(s)
Microbicides
Study Design
Randomized
Open label
Arms and Assigned Interventions
Description
A single dose of study product using an HTI vaginal applicator
Mode of Delivery
Gel
Products
dapivirine gel
ARMs
Experimental
Description
Up to 10 mLs of gel applied as a rectal lubricant using a coital simulation device
Mode of Delivery
Gel
Products
dapivirine gel
ARMs
Experimental
Official Code
NCT03393468
Trial Sponsors
NIAID (DAIDS-ES: 12065), NIMH, NIH
May 2018
October 2018
Enrollment
16
18
Years
Population
Men
Sites

University of Pittsburgh CRS

Pittsburgh, Pennsylvania
United States of America