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

A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel in Healthy HIV-Negative Women.

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: dapivirine (TMC120) vaginal gel

• Study Type: Interventional
• Enrollment: 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Africa
  • Bloemfontein, South Africa
    • Farmovs-Parexel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: International Partnership for Microbicides, Inc.
• Investigators: Study Director: Zeda Rosenberg, ScD, IPM

Study record dates

Study Major Dates

• Study Start: November 1, 2005

Study Registration Dates

• First Submitted: March 16, 2006
• First Submitted That Met QC Criteria: March 17, 2006
• First Posted (Estimate): March 20, 2006

Study Record Updates

• Last Update Posted (Estimate): June 2, 2006
• Last Update Submitted That Met QC Criteria: June 1, 2006
• Last Verified: June 1, 2006

More Information

Terms related to this study

• Keywords: HIV Seronegativity; HIV-1
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Dapivirine
• Other Study ID Numbers: IPM004