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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00304642
• Other study ID #: IPM004
• Status: Completed
• Phase: Phase 1
• First received: March 16, 2006
• Last updated: June 1, 2006
• Start date: November 2005

Study information

• Verified date: June 2006
• Source: International Partnership for Microbicides, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• dapivirine (TMC120) vaginal gel

Locations

Country	Name	City	State
South Africa	Farmovs-Parexel	Bloemfontein

Sponsors (1)

Lead Sponsor	Collaborator
International Partnership for Microbicides, Inc.

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.