A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in South Africa
HIV Infections
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV-1, HIV Seronegativity
Eligibility Criteria
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.