A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in Belgium
A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in Belgium
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.
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.