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

Sponsor
International Partnership for Microbicides, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00304642
Collaborator
(none)
18
Enrollment
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: dapivirine (TMC120) vaginal gel
 Phase 1

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Prevention
Official Title:
A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel in Healthy HIV-Negative Women.
Study Start Date :
Nov 1, 2005

Outcome Measures

Primary Outcome Measures

  1. 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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Farmovs-Parexel Bloemfontein South Africa

Sponsors and Collaborators

  • International Partnership for Microbicides, Inc.

Investigators

  • Study Director: Zeda Rosenberg, ScD, IPM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00304642
Other Study ID Numbers:
  • IPM004
First Posted:
Mar 20, 2006
Last Update Posted:
Jun 2, 2006
Last Verified:
Jun 1, 2006
Keywords provided by , ,
HIV-1
HIV Seronegativity
Additional relevant MeSH terms:
HIV Infections
Dapivirine

Study Results

No Results Posted as of Jun 2, 2006