A Safety Study of Dapivirine Vaginal Ring in Africa
Phase 1
Completed
- Conditions
- HIV Infections
- Registration Number
- NCT01071174
- Lead Sponsor
- International Partnership for Microbicides, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 280
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (10)
Kenya Medical Research Institute (KEMRI)
🇰🇪Kisumu, Kenya
University of North Carolina Project
🇲🇼Lilongwe, Malawi
Reproductive Health and HIV Research Unit (RHRU)
🇿🇦Edendale, Kwazulu Natal, South Africa
Qhakaza Mbokodo
🇿🇦Ladysmith, Kwazulu Natal, South Africa
Prevention for HIV and AIDS Project (PHIVA)
🇿🇦Pinetown, Kwazulu Natal, South Africa
Madibeng Centre for Research
🇿🇦Brits, North West, South Africa
Desmond Tutu HIV Foundation Masiphumelele
🇿🇦Cape Town, Western Cape, South Africa
Desmond Tutu HIV Foundation Nyanga
🇿🇦Cape Town, Western Cape, South Africa
Be Part Yoluntu Centre Mbekweni
🇿🇦Paarl, Western Cape, South Africa
Kilimanjaro Christian Medical Centre (KCMC)
🇹🇿Moshi, Tanzania
Kenya Medical Research Institute (KEMRI)🇰🇪Kisumu, Kenya