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Status
Completed
Phase
II
Principal Investigator(s)
Kathleen Squires, Katherine Bunge
Objective
Study to assess the safety of dapivirine vaginal ring (inserted every 4 weeks) in HIV-negative adolescent females.
*Closed to follow up as of 7/5/16*
Last updated May 16, 2021
Prevention Option(s)
Microbicides
Study Design
Controlled
Randomized
Double-blind
Arms and Assigned Interventions
Mode of Delivery
Ring
Products
Dapivirine Ring
ARMs
Experimental
Description
silicone vaginal ring
Mode of Delivery
Ring
ARMs
Placebo Comparator
Official Code
Trial Sponsors
International Partnership for Microbicides, Inc., NIAID (DAIDS-ES: 11927), NICHD, ATN, MTN
March 2014
July 2016
Enrollment
96
15
Years
17
Years
Population
Women
Sites
University of Alabama at Birmingham
Birmingham, Alabama
United States of America
Bronx-Lebanon Hospital
New York, New York
United States of America
Fenway Institute
Boston, Massachusetts
United States of America
University of Colorado at Denver
Denver, Colorado
United States of America
St. Jude Childrens Research Hospital
Memphis, Tennessee
United States of America
University of Pittsburgh CRS
Pittsburgh, Pennsylvania
United States of America
Magee Women's Hospital of UPMC
Pittsburgh
United States of America