Safety and Adherence of a Non-medicated Intravaginal Ring (IVR) (MTN-005)
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 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|
- 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 ]
|Study Start Date:||May 2011|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268332
|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|
|National AIDS Research Institute|
|Study Chair:||Craig Hoesley, MD||University of Alabama at Birmingham|