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Safety and Pharmacokinetics (PK) of a Polyurethane Tenofovir Disoproxil Fumarate (TDF) Vaginal Ring (TDF IVR-002)

Status
Stopped Early
Phase
I
Principal Investigator(s)
Marla J Keller, MD
Objective

This prospective, two-site, two-arm, randomized, single-blind, placebo-controlled trial will examine the safety and pharmacokinetics (PK) of a polyurethane tenofovir disoproxil fumarate (TDF) vaginal ring when used continuously for 84 consecutive days by sexually active women.

The primary objective is to assess the safety of TDF vaginal rings when used continuously for 84 days by healthy, HIV-uninfected, sexually active women, as compared with a placebo vaginal ring.

Prevention Option(s)
Microbicides
Study Design
Randomized
Blind
Arms and Assigned Interventions
Description
The TDF vaginal ring is a flexible torus-shaped device with an inner core that contains the experimental drug, TDF. The ring is worn for 28 days at a time and changed every 28 days for total of 3 months.
Mode of Delivery
Ring
Products
TDF
ARMs
Experimental
Description
The placebo polyurethane is a flexible torus-shaped device with an inner core that contains sodium chloride. The ring is worn for 28 days at a time and changed every 28 days for a total of 3 months.
Mode of Delivery
Ring
ARMs
Placebo Comparator
Trial Sponsors
Albert Einstein College of Medicine of Yeshiva University
January 2017
December 2018
Enrollment
80
18
Years
45
Years
Population
Women
Sites

Albert Einstein College of Medicine

Bronx, New York
United States of America

Kenya Medical Research Institute

Kenya