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

Phase 1

Completed

• Conditions: HIV Infections

• Registration Number: NCT00304642
• Lead Sponsor: International Partnership for Microbicides, Inc.

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 (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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-03-16
• Study First Submitted QC: 2006-03-17
• Study First Posted: 2006-03-20
• Status Verified: 2006-06
• Last Update Submitted: 2006-06-01
• Last Update Posted: 2006-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To assess plasma levels and pharmacokinetics of dapivirine applied vaginally. To measure vaginal fluid and vaginal tissue levels of dapivirine at various time after application of the gel.

Trial Locations

Locations (1)

Farmovs-Parexel; 🇿🇦 Bloemfontein, South Africa