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

This study has been completed.
Sponsor:
Collaborators:
Microbicide Trials Network
Information provided by (Responsible Party):
Population Council
ClinicalTrials.gov Identifier:
NCT01268332
First received: December 28, 2010
Last updated: January 4, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Healthy
Drug: Non-medicated Intravaginal Ring
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Expanded Safety and Adherence Study of a Non-medicated Intravaginal Ring

Further study details as provided by Population Council:

Primary Outcome Measures:
  • Adherence to intravaginal ring [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Grade 2 or higher adverse event [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Enrollment: 195
Study Start Date: May 2011
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Placebo Intravaginal Ring
No Intervention: No Intravaginal Ring
Intravaginal ring will not be inserted into participants.

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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268332

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States
United States, New York
Bronx-Lebanon Hospital Center
Bronx, New York, United States
India
National AIDS Research Institute
Pune, India
Sponsors and Collaborators
Population Council
Microbicide Trials Network
Investigators
Study Chair: Craig Hoesley, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Population Council
ClinicalTrials.gov Identifier: NCT01268332     History of Changes
Obsolete Identifiers: NCT00672425
Other Study ID Numbers: Population Council #508
Study First Received: December 28, 2010
Last Updated: January 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Population Council:
Placebo IVR as a delivery method

ClinicalTrials.gov processed this record on August 18, 2014