A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: International Partnership for Microbicides, Inc.
• Treatments: Anti-Infective Agents; Dapivirine

Criteria

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.