A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel
A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel
Approximately 18 women will be enrolled in this single-center, double-blind, randomized Phase
 I study to assess vaginal tissue and fluid levels, plasma levels and pharmacokinetics of
 dapivirine (TMC120) gel, which will be applied for 10 consecutive days in 18 healthy
 HIV-negative women ages 18 to 50. Volunteers will be randomized in a 1:1:1 ratio to receive
 2.5mL dapivirine vaginal microbicide gel at one of three concentrations.
Inclusion Criteria:

 -  HIV-negative

 -  Willing to participate and sign and informed consent form.

 -  Willing to be tested for HIV and to use an experimental vaginal gel.

 -  Willing to use a reliable form of contraception during the study.

 -  Willing to undergo pelvic examinations with colposcopy according to the protocol
 throughout the study.

 -  Normal cervical assessment.

 -  Willing to abstain from using any vaginal product (other than the study product).

 -  Willing to be sexually abstinent from Day 1 until completion of study product use on
 Day 10.

 Exclusion Criteria:

 -  Currently pregnant or breast-feeding.

 -  Currently has any clinically detectable abnormality on the vulva, vaginal walls or
 cervix.

 -  Currently has laboratory confirmed gonorrhea, chlamydia, trichomonas or syphilis, has
 Genital Ulcer Disease (GUD) or vaginal candidiasis symptoms; or has an HSV-2 lesion as
 indicated by clinical diagnosis or laboratory test.

 -  Symptomatic bacterial vaginosis (BV) and unwilling to undergo treatment.

 -  Current use of injection drugs.