Feasibility Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine)

Study Overview
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Brief Summary
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The purpose of this trial was to evaluate the safety and feasibility of using a vaginal ring to deliver the candidate microbicide TMC120 (dapivirine). Twelve women initially underwent 7-day exposure to a placebo ring containing no investigational agent. They then underwent 7-day exposure to a ring containing 120 mg of TMC120 (dapivirine). Feasibility was assessed in terms of safety and tolerability as well as drug delivery.

Official Title
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Phase I Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine) as a Vaginal Microbicide

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: placebo vaginal ring
* Drug: TMC120 (dapivirine) vaginal ring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female, 18-50 years, inclusive Willing and able to provide written informed consent HIV-uninfected and otherwise healthy Willing to abstain from sexual activity and use of vaginal products while participating in the trial Currently using oral contraceptives for pregnancy prevention Willing to use oral contraceptives as needed to avoid menstruation while taking part in this trial Exclusion Criteria: History of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation, or other emotional or intellectual problems that are likely to invalidate the informed consent process or adversely impact compliance with protocol requirements. History of allergy to TMC120 or to the constituents of the vaginal ring. History of hypersensitivity to propofol, or other contraindication to general anesthesia or sedation History of diagnosis of and/or treatment for a sexually transmitted disease within the last three months. History of genital tract surgery within the last month Currently pregnant or breastfeeding, or within two months of last pregnancy outcome Currently or within one month of participating in any other clinical research trial Current (during screening) diagnosis of any genital infection Current vulvar of vaginal symptoms Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br> | Drug: placebo vaginal ring<br>* vaginal ring containing no TMC120 (dapivirine)<br>|
| Experimental: B<br> | Drug: TMC120 (dapivirine) vaginal ring<br>* vaginal ring containing 120 mg TMC120 (dapivirine)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability of a vaginal ring containing TMC120 (dapivirine) |  | 7 days | 
| TMC120 (dapivirine) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-I, Reverse transcriptase inhibitors, HIV Seronegativity