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

• Status: Withdrawn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

Summary

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.

• Phase: Phase 1/Phase 2
• 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 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.