A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in South Africa

A Phase I/II Single-Centre Double-Blinded Randomized Study of the Safety and Tolerability of TMC120 Vaginal Microbicide Gel (TMC120 Gel-002) vs. HEC-Based Universal Placebo Gel in Healthy HIV-Negative Women.

Approximately 42 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-002 versus placebo. The volunteers will receive investigational product for a total of 42 days.

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.