A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method

Study Overview
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Brief Summary
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The proposed study is a multi-centre, open-label crossover study to assess the safety and acceptability of a silicone elastomer vaginal ring (containing no drug) when inserted for a 12 week period in 200 healthy, sexually active women.

Official Title
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A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method for the Prevention of HIV Infection in Women

Conditions
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HIV Infections

Intervention / Treatment
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* Device: intravaginal ring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female, age 18-35 years Willing and able to provide written informed consent HIV-uninfected and otherwise healthy Self-reported sexually active On a stable hormonal contraceptive regimen Regular menstrual cycle Willing to refrain from use of vaginal products or objects during the study Exclusion Criteria: Currently pregnant or last pregnancy within 3 months prior to enrollment Currently breast-feeding Participated in any other research study within 30 days prior to enrollment; Symptomatic untreated vaginal infections within 2 weeks prior to enrollment Presence of abnormal physical finding on the vulva, vaginal walls or cervix History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction; Pap smear result at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior to enrollment Any serious acute, chronic or progressive disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>vaginal ring first 12 weeks & observational safety last 12 weeks | Device: intravaginal ring<br>* silicone elastomer intravaginal ring containing no drug product<br>|
| Experimental: B<br>observational safety first 12 weeks & vaginal ring last 12 weeks | Device: intravaginal ring<br>* silicone elastomer intravaginal ring containing no drug product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary measure of acceptability will be defined as the proportion of women indicating that they would use the study product if it is found to prevent HIV. |  | 3 months | 
| The primary measure of safety will be the proportion of women who have abnormal observations during the pelvic/speculum examinations and the proportion of women who experience adverse events |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-1, HIV seronegativity