Status:
COMPLETED
A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in Belgium
Lead Sponsor:
International Partnership for Microbicides, Inc.
Conditions:
HIV Infections
HIV-1
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00309205
Start Date
December 1 2005
Last Update
September 1 2009
Active Locations (1)
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1
SGS Biopharma - Research Unit Stuivenberg
Antwerp, Belgium, 2060