Email Updates

You are here

MTN-044/IPM 053

Status
Ongoing
Phase
Open Label
I
Objective

This is a Phase I single-center, two-arm, open-label, randomized study in healthy HIV-negative women to evaluate the pharmacokinetics, safety, and bleeding patterns associated with 90-day use of matrix vaginal rings containing 200 mg Dapivirine and 320 mg Levonorgestrel.One silicone elastomer vaginal ring (VR) containing the active 200 mg dapivirine (DPV) and 320 mg levonorgestrel (LNG), used continuously for approximately 90 days.

Prevention Option(s)
Microbicides
Multipurpose Prevention Technologies
Study Design
Randomized
Arms and Assigned Interventions
Description
One silicone elastomer vaginal ring (VR) containing the active 200 mg dapivirine (DPV) and 320 mg levonorgestrel (LNG), used continuously for approximately 90 days.
Mode of Delivery
Ring
Products
Dapivirine-Levonorgestrel ring
ARMs
Experimental
Description
One silicone elastomer vaginal ring (VR) containing the active 200 mg dapivirine (DPV) and 320 mg levonorgestrel (LNG), used cyclically for approximately 90 days. Use the VR for 28 days, remove for 2 days.
Mode of Delivery
Ring
Products
Dapivirine-Levonorgestrel ring
ARMs
Experimental
June 2018
October 2019
Enrollment
24
18
Years
45
Years
Population
Women
Sites

University of Pittsburgh CRS

Pittsburgh, Pennsylvania
United States of America