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

Sponsor
Population Council (Other)
Overall Status
Completed
CT.gov ID
NCT01268332
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) (NIH), National Institute of Mental Health (NIMH) (NIH), Microbicide Trials Network (Other)
195
Enrollment
3
Locations
2
Arms
22.2
Duration (Months)
65
Patients Per Site
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Non-medicated Intravaginal Ring
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
195 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Expanded Safety and Adherence Study of a Non-medicated Intravaginal Ring
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Mar 7, 2013

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Adherence to intravaginal ring [Throughout study]

    2. Grade 2 or higher adverse event [Throughout study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States
    2 Bronx-Lebanon Hospital Center The Bronx New York United States
    3 National AIDS Research Institute Pune India

    Sponsors and Collaborators

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

    Investigators

    • Study Chair: Craig Hoesley, MD, University of Alabama at Birmingham

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Population Council
    ClinicalTrials.gov Identifier:
    NCT01268332
    Other Study ID Numbers:
    • Population Council #508
    • NCT00672425
    First Posted:
    Dec 30, 2010
    Last Update Posted:
    Aug 15, 2017
    Last Verified:
    Aug 1, 2017
    Keywords provided by Population Council
    Placebo IVR as a delivery method

    Study Results

    No Results Posted as of Aug 15, 2017