A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in Belgium
Phase 1
Completed
- Conditions
- HIV InfectionsHIV-1
- Registration Number
- NCT00309205
- Lead Sponsor
- International Partnership for Microbicides, Inc.
- Brief Summary
Approximately 36 HIV-negative women, aged \>18 and \< 50, will be enrolled in this study. Each volunteer will have a 2:1 chance of receiving dapivirine gel versus placebo. The volunteers will receive investigational product for a total of 42 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 36
Inclusion Criteria
- HIV-negative
- Willing to participate and sign an informed consent form
- Willing to be tested for HIV, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group.
- Willing to use two forms of contraception during the study
- Willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study.
- Have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses
Exclusion Criteria
- Currently pregnant or breast-feeding
- Clinically detectable genital abnormality on the vulva, vaginal walls or cervix
- Laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed GUD or active HSV-2 lesion
- Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization
- Symptomatic bacterial vaginosis at Screening and unwilling to undergo treatment.
- Women who require treatment for tuberculosis (TB) within 21 days prior to randomization.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Local and systemic safety and tolerability.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
SGS Biopharma - Research Unit Stuivenberg
🇧🇪Antwerp, Belgium