Safety and Adherence of a Non-medicated Intravaginal Ring (IVR) - Full Text View

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

This study is currently recruiting participants.

Verified July 2011 by Population Council

First Received on December 28, 2010. Last Updated on July 13, 2011 History of Changes

Sponsor:	Population Council
Collaborators:	National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Mental Health (NIMH) Microbicide Trials Network
Information provided by:	Population Council
ClinicalTrials.gov Identifier:	NCT01268332

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	Other: Non-medicated Intravaginal Ring	Phase II

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 ]

Estimated Enrollment:	252
Study Start Date:	May 2011
Estimated Primary Completion Date:	May 2013 (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.	Other: 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

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

Locations

United States, Alabama
University of Alabama at Birmingham	Recruiting
Birmingham, Alabama, United States
Contact: Craig Hoesley, MD 205-934-3365 choesley@uab.edu
Principal Investigator: Criag Hoesley, MD
United States, New York
Bronx-Lebanon Hospital Center	Recruiting
Bronx, New York, United States
Contact: Jessica Justman, MD 212-342-1824 jj2158@columbia.edu
Principal Investigator: Jessica Justman, MD
India
National AIDS Research Institute	Not yet recruiting
Pune, India
Contact: Sanjay Mehendale, MBBS, MD, MPH 91-20-2712-1280 smehendale@nariindia.org

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

More Information

No publications provided

Responsible Party:	Deborah Tolenaar, Clinical Project Manager, 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:	July 13, 2011
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 February 12, 2012