Safety and Adherence of a Non-medicated Intravaginal Ring (IVR) (MTN-005)

August 11, 2017 updated by: Population Council

Expanded Safety and Adherence Study of a Non-medicated Intravaginal Ring

The purpose of this study is to evaluate the safety of and adherence to a non-medicated IVR in HIV uninfected women over 12 weeks of use.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women comprise a growing proportion of new HIV infections worldwide. Intravaginal rings (IVRs) used to deliver microbicides have the potential to significantly reduce the heterosexual transmission of HIV if found to be safe, acceptable, and effective against HIV infection. This study will investigate the safety and acceptability of a non-medicated silicone elastomer IVR in sexually active HIV uninfected women.

The expected duration of this study for each participant is 16 weeks. Study participants will be randomly assigned to one of two arms. Participants in Group A will insert an IVR into their vagina at study entry. The IVR will remain in place for 12 weeks until removed by a physician. Follow up will continue for an additional 4 weeks after IVR removal. Participants in Group B will not receive an IVR, but will follow the same study schedule as those in Group A.

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Phase 2

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

  • India
      • Pune, India
        • National AIDS Research Institute
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • University of Alabama at Birmingham
    • New York
      • The Bronx, New York, United States
        • Bronx-Lebanon Hospital Center

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 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • HIV uninfected
  • General good health
  • Sexually active
  • Agree to use an effective method of contraception
  • Normal Pap smear result within 12 months prior to study entry
  • Agree to not participate in other drug or device research studies for the duration of study participation
  • Agree to not use any intravaginal product for the duration of study participation

Exclusion Criteria:

  • History of adverse reaction to silicone, latex, or titanium dioxide
  • Current male sex partner with known history of adverse reaction to silicone, latex, or titanium dioxide
  • Last pregnancy outcome within 30 days or less prior to enrollment
  • History of hysterectomy
  • Any abnormal pelvic exam finding
  • Pregnant
  • Condition that, in the opinion of the investigator, would interfere with the study
  • Severe pelvic relaxation

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intravaginal Ring
Insertion of intravaginal ring at enrollment. The intravaginal ring should stay in place for 12 consecutive weeks and will be removed by a physician at the Week 12 study visit.
Drug: Non-medicated Intravaginal Ring
Cured silicone elastomer composed of an elastomer base, normal propylorthosilicate, and titanium dioxide. The ring will not contain an active pharmaceutical ingredient.
Other Names:
  • Placebo Intravaginal Ring
NO_INTERVENTION: No Intravaginal Ring
Intravaginal ring will not be inserted into participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adherence to intravaginal ring
Time Frame: Throughout study
Throughout study
Grade 2 or higher adverse event
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

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

Sponsor

Population Council

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Mental Health (NIMH)
Microbicide Trials Network

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

May 1, 2011

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

March 7, 2013

Study Registration Dates

First Submitted

December 28, 2010

First Submitted That Met QC Criteria

December 29, 2010

First Posted (ESTIMATE)

December 30, 2010

Study Record Updates

Last Update Posted (ACTUAL)

August 15, 2017

Last Update Submitted That Met QC Criteria

August 11, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Population Council #508

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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