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

This study has been completed.
Sponsor:
Information provided by:
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT00304642
First received: March 16, 2006
Last updated: June 1, 2006
Last verified: June 2006

March 16, 2006
June 1, 2006
November 2005
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00304642 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
HIV Infections
Drug: dapivirine (TMC120) vaginal gel
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
Not Provided
Not Provided

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.
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00304642
IPM004
Not Provided
Not Provided
International Partnership for Microbicides, Inc.
Not Provided
Study Director: Zeda Rosenberg, ScD IPM
International Partnership for Microbicides, Inc.
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP