A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium

Study Overview
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Brief Summary
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IPM 018 is a double-blind, randomized, placebo-controlled study conducted at one site in Belgium among 24 healthy, HIV-negative women to evaluate dapivirine release for 28 days from matrix and reservoir intravaginal rings, each containing 25 mg of dapivirine, and to assess safety and tolerability compared to placebo

Official Title
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A Double-blind, Randomized, Placebo-controlled Safety and Pharmacokinetic Study in Healthy HIV-negative Women to Assess the Delivery of Dapivirine From Matrix and Reservoir Intravaginal Rings Each Containing 25 mg of Dapivirine

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: dapivirine reservoir intravaginal ring
* Drug: dapivirine matrix intravaginal ring
* Other: placebo intravaginal ring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between 18 and 35 years of age Willing and able to give written informed consent Available for all visits and consent to follow all procedures scheduled for the study Healthy and HIV-negative as determined by a HIV-1 ELISA test at time of enrollment; Willing to abstain from sexual activity for the duration of the study Willing to use oral contraceptives to avoid menstruation while taking part in this study or on long-acting progestins for 6 months prior to enrollment Upon pelvic / speculum examination at enrollment, the cervix and vagina appear normal Willing to refrain from use of vaginal products or objects for the duration of the study. 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 sensitivity / allergy to latex, dapivirine or to the constituents of the vaginal ring (i.e. silicone elastomer) Currently pregnant or breast-feeding, or within three months of last pregnancy outcome Currently or within one month of participating in any other clinical research study History or diagnosis of and / or treatment for a sexually transmitted disease within the last three months History of genital tract surgery within the last month Current diagnosis of sexually transmitted infections (Gonorrhea, Chlamydia and Trichomonas) Current vulvar or vaginal symptoms / abnormalities that could influence the study results History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction within the last three months; Smoking more than 10 cigarettes per day

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: dapivirine matrix intravaginal ring<br>* a silicone elastomer matrix intravaginal ring containing 25mg of dapivirine<br>|
| Experimental: B<br> | Drug: dapivirine reservoir intravaginal ring<br>* a silicone elastomer reservoir ring containing 25mg of dapivirine<br>|
| Placebo Comparator: C<br> | Other: placebo intravaginal ring<br>* a silicone elastomer intravaginal ring containing no dapivirine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

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