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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
Placebo
Randomized
Double-blind
Arms and Assigned Interventions
Description
Combination vaginal ring dosage: 25 mg dapivirine + 100 mg maraviroc ring; frequency: continuous use; duration 28 days
Mode of Delivery
Ring
Products
Dapivirine Ring
Maraviroc Ring
ARMs
Experimental
Description
Placebo vaginal ring: N/A; frequency: continuous use; duration: 28 days
Mode of Delivery
Ring
ARMs
Placebo Comparator
Description
100mg dosage Maraviroc vaginal ring; frequency: continuous use; duration: 28 days
Mode of Delivery
Ring
Products
Maraviroc Ring
ARMs
Experimental
Description
25mg dosage Dapivirine vaginal ring; frequency: continuous use; duration: 28 days
Mode of Delivery
Ring
Products
Dapivirine Ring
ARMs
Experimental
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
November 2011
April 2013
Enrollment
48
18
Years
40
Years
Population
Women
Sites

Fenway Community Health Clinical Research Site (FCHCRS)

Boston, Massachusetts
United States of America

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania
United States of America

University of Alabama at Birmingham

Birmingham, Alabama
United States of America