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MTN 038

Status
Ongoing
Phase
I
Objective

A Phase 1, Randomized, Pharmacokinetic and Safety Study of a 90 Day Intravaginal Ring Containing Tenofovir

 

Last updated May 3, 2021

Prevention Option(s)
Microbicides
Study Design
Randomized
Arms and Assigned Interventions
Description
Experimental: Tenofovir (TFV) Intravaginal Ring (IVR) The TFV IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Drug: Tenofovir (TFV) IVR Contains 1.4 g TFV
Mode of Delivery
Ring
Products
TFV ring
ARMs
Experimental
Description
Placebo Comparator: Placebo IVR The placebo IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Drug: Placebo IVR Contains placebo
Mode of Delivery
Ring
ARMs
Placebo Comparator
Trial Sponsors
NIAID (DAIDS-ES: 38460)
December 2018
September 2019
Enrollment
49
18
Years
45
Years
Population
Women
Sites

Alabama Microbicide CRS

Birmingham, Alabama
United States of America

University of Pittsburgh CRS

Pittsburgh, Pennsylvania
United States of America

Bridge HIV CRS

San Francisco, California
United States of America