Status:
COMPLETED
A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel
Lead Sponsor:
International Partnership for Microbicides, Inc.
Conditions:
HIV Infections
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
Brief 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 (TMC12...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00304642
Start Date
November 1 2005
Last Update
June 2 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Farmovs-Parexel
Bloemfontein, South Africa