IPM 026/MTN 013

Status:Completed
Phase:I
Principal Investigator(s):Beatrice A Chen
Objective:To assess the pharmacokinetics of the combination dapivirine and maraviroc vaginal ring and determine whether it is safe when used continuously for 28 days by healthy women in the United States.   Results: There was no difference in related genitourinary adverse events between treatment arms compared with placebo.
Prevention Option(s):Microbicides
Study Design:Controlled, Double-blind, Placebo, Randomized
Arms and Assigned Interventions
DescriptionCombination vaginal ring dosage: 25 mg dapivirine + 100 mg maraviroc ring; frequency: continuous use; duration 28 days
Mode of DeliveryRing
ARMsExperimental
Description100mg dosage Maraviroc vaginal ring; frequency: continuous use; duration: 28 days
Mode of DeliveryRing
ARMsExperimental
Description25mg dosage Dapivirine vaginal ring; frequency: continuous use; duration: 28 days
Mode of DeliveryRing
ARMsExperimental
Results: Phase 1 Safety, Pharmacokinetics, and Pharmacodynamics of Dapivirine and Maraviroc Vaginal Rings: a Double-Blind Randomized Trial
Official Code: NCT01363037
Trial Sponsors: IPM, MTN, NIAID
Start Date
End Date
November 30, 2011
April 30, 2013
Enrollment:48
Age range: 18 Years ↔ 40 Years
Population:Cisgender Women