A Safety Study of Dapivirine Vaginal Ring in Africa

Study Overview
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Brief Summary
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This is a double-blind, randomized, placebo-controlled Phase I/II study to assess the safety of a silicone elastomer vaginal ring containing 25mg dapivirine.

Official Title
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A Double-Blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety of an Intravaginal Matrix Ring With Dapivirine in Healthy, HIV-Negative Women.

Conditions
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HIV Infections

Intervention / Treatment
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* Other: Dapivirine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between 18 and 40 years of age inclusive who can provide informed consent Available for all visits and consent to follow all procedures scheduled for the study Healthy and self-reported sexually active HIV-negative On a stable form of contraception and willing to continue OR have undergone surgical sterilization at least 3 months prior to enrollment In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle defined as having a minimum of 21 days and a maximum of 35 days between menses Upon pelvic/speculum examination and colposcopy at the time of enrolment, the cervix and vagina appear normal as determined by the investigator Asymptomatic for genital infections at the time of enrolment Willing to refrain from use of vaginal products or objects within 14 days from enrollment and for the duration of the study Willing to answer to acceptability, adherence and behavioural assessments throughout the study Willing to refrain from participation in any other research study for the duration of their participation Willing to provide adequate locator information for study retention purposes and be reachable per local standard procedures Exclusion Criteria: Currently pregnant or last pregnancy within 3 months prior to enrolment Currently breast-feeding Participated in any other research study within 60 days prior to screening Previously participated in any HIV vaccine study Untreated urogenital infections within 2 weeks prior to enrolment Presence of any abnormal physical finding on the vulva, vaginal walls or cervix during pelvic/speculum examination and/or colposcopy History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, or urethral obstruction, incontinence or urge incontinence Pap smear result at screening that requires cryotherapy, biopsy, treatment or further evaluation Any Grade 2, 3 or 4 baseline (screening) haematology, chemistry or urinalysis laboratory abnormality according to the DAIDS Table for Grading Adverse Events Any abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrolment Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex or silicone elastomer Any serious acute, chronic or progressive disease Any condition(s) that, in the opinion of the investigator, might interfere with adherence to study requirements or evaluation of the study objectives

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Ring<br>Vaginal Ring containing no drug substance | Other: Placebo<br>* Vaginal Ring containing no drug substance<br>|
| Experimental: Dapivirine Ring<br>Dapivirine Vaginal Ring 25mg | Other: Dapivirine<br>* Vaginal ring containing 25mg dapivirine; One ring inserted every 28 days for 84 days (3 rings total)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as determined by the proportion of women in each arm experiencing protocol-specified events, including AEs, laboratory abnormalities, cervico-vaginal abnormalities, abnormal vaginal flora/pH during the study. |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of the product determined by questionnaire. |  | 16 weeks | 
| Adherence to the protocol-specific product regimen as determined by self-report and clinician observation at each study visit. |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV infections, Anti-HIV agents, HIV-1