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MTN-036/IPM 047

Status
Ongoing
Phase
I
Objective

MTN-036/IPM 047 is a Phase 1, randomized, three-arm, open label trial. The study will assess the safety and pharmacokinetics (PK) of three silicone elastomer intravaginal rings (VRs) containing either 25 mg or 200 mg of the active ingredient dapivirine (DPV) formulated using either polymer 4320 or 4870.

*The study is closed to follow up*

Last updated October 2, 2019 

Prevention Option(s)
Microbicides
Study Design
Randomized
Open label
Arms and Assigned Interventions
Description
Participants will insert one Dapivirine Vaginal Ring, 25 mg to be replaced every 4 weeks for 8 weeks, then worn for an additional 5 weeks for a total of 13 weeks.
Mode of Delivery
Ring
Products
Dapivirine Ring
ARMs
Experimental
Description
Participants will insert one Dapivirine Vaginal Ring, 100 mg to be used continuously for 13 weeks
Mode of Delivery
Ring
Products
Dapivirine Ring
ARMs
Experimental
Description
Participants will insert one Dapivirine Vaginal Ring, 200 mg to be used continuously for 13 weeks.
Mode of Delivery
Ring
Products
Dapivirine Ring
ARMs
Experimental
Trial Sponsors
NIAID, NICHD, NIMH, NIH, IPM
September 2017
January 2019
Enrollment
48
18
Years
45
Years
Population
Women
Sites

Alabama Microbicide CRS

Birmingham, Alabama
United States of America

Bridge HIV CRS

San Francisco, California
United States of America