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

NCT02762617 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2018-08-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Tenofovir disoproxil fumarate intravaginal ring

The TDF IVR is formulated using preformed flexible tubing, comprised of biomedical medical grade hydrophilic, aliphatic polyurethane, and an inner core compartment comprised of 86% (w/w) TDF and 14% (w/w) sodium chloride. The ring will be inserted by the study clinician and worn for 28 day intervals for a total of 3 months (84 days). The ring will be removed and replaced with a new ring at each 28 day interval.

DRUG

Placebo intravaginal ring (IVR)

The Placebo IVR is formulated using preformed flexible tubing, comprised of biomedical medical grade hydrophilic, aliphatic polyurethane, and an inner core compartment comprised of sodium chloride. The ring will be inserted by the study clinician and worn for 28 day intervals for a total of 3 months (84 days). The ring will be removed and replaced with a new ring at each 28 day interval.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Marla Keller

    lead OTHER

Principal Investigators

  • Marla J Keller, MD · Albert Einstein College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-24
Primary Completion
2017-10-17
Completion
2017-10-17
FDA Drug
Yes

Countries

  • United States
  • Kenya

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02762617 on ClinicalTrials.gov