Feasibility Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine)

August 31, 2009 updated by: International Partnership for Microbicides, Inc.

Phase I Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine) as a Vaginal Microbicide

The purpose of this trial was to evaluate the safety and feasibility of using a vaginal ring to deliver the candidate microbicide TMC120 (dapivirine). Twelve women initially underwent 7-day exposure to a placebo ring containing no investigational agent. They then underwent 7-day exposure to a ring containing 120 mg of TMC120 (dapivirine). Feasibility was assessed in terms of safety and tolerability as well as drug delivery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • Drug Research Unit, UZ Gent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female, 18-50 years, inclusive
  • Willing and able to provide written informed consent
  • HIV-uninfected and otherwise healthy
  • Willing to abstain from sexual activity and use of vaginal products while participating in the trial
  • Currently using oral contraceptives for pregnancy prevention
  • Willing to use oral contraceptives as needed to avoid menstruation while taking part in this trial

Exclusion Criteria:

  • History of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation, or other emotional or intellectual problems that are likely to invalidate the informed consent process or adversely impact compliance with protocol requirements.
  • History of allergy to TMC120 or to the constituents of the vaginal ring.
  • History of hypersensitivity to propofol, or other contraindication to general anesthesia or sedation
  • History of diagnosis of and/or treatment for a sexually transmitted disease within the last three months.
  • History of genital tract surgery within the last month
  • Currently pregnant or breastfeeding, or within two months of last pregnancy outcome
  • Currently or within one month of participating in any other clinical research trial
  • Current (during screening) diagnosis of any genital infection
  • Current vulvar of vaginal symptoms
  • Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: B
Drug: TMC120 (dapivirine) vaginal ring
vaginal ring containing 120 mg TMC120 (dapivirine)
PLACEBO_COMPARATOR: A
Drug: placebo vaginal ring
vaginal ring containing no TMC120 (dapivirine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
safety and tolerability of a vaginal ring containing TMC120 (dapivirine)
Time Frame: 7 days
7 days
TMC120 (dapivirine) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Partnership for Microbicides, Inc.

Collaborators

Tibotec Pharmaceutical Limited

Investigators

  • Principal Investigator: Dr Luc Van Bortel, Drug Research Unit, UZ Gent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (ACTUAL)

January 1, 2005

Study Completion (ACTUAL)

January 1, 2005

Study Registration Dates

First Submitted

June 16, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (ESTIMATE)

June 18, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 1, 2009

Last Update Submitted That Met QC Criteria

August 31, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPM 001, TMC120-C130

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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