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

Phase 2

Completed

• Conditions: Healthy
• Interventions: Drug: Non-medicated Intravaginal Ring

• Registration Number: NCT01268332
• Lead Sponsor: Population Council

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.

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 Timeline

• Study First Submitted: 2010-12-28
• Study First Submitted QC: 2010-12-29
• Study First Posted: 2010-12-30
• Study Start: 2011-05
• Primary Completion: 2012-09
• Study Completion: 2013-03-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-11
• Last Update Posted: 2017-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 195

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravaginal Ring	Non-medicated 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.

Primary Outcome Measures

Name	Time	Method
Grade 2 or higher adverse event	Throughout study
Adherence to intravaginal ring	Throughout study

Trial Locations

Locations (3)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Bronx-Lebanon Hospital Center; 🇺🇸 The Bronx, New York, United States

National AIDS Research Institute; 🇮🇳 Pune, India