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
  Purpose

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 Intervention Phase
HIV Infections
Drug: dapivirine (TMC120) vaginal gel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel in Healthy HIV-Negative Women.

Resource links provided by NLM:


Further study details as provided by International Partnership for Microbicides, Inc.:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 18
Study Start Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304642

Locations
South Africa
Farmovs-Parexel
Bloemfontein, South Africa
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Investigators
Study Director: Zeda Rosenberg, ScD IPM
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00304642     History of Changes
Other Study ID Numbers: IPM004
Study First Received: March 16, 2006
Last Updated: June 1, 2006
Health Authority: United States: Food and Drug Administration
South Africa: Medicines Control Council

Keywords provided by International Partnership for Microbicides, Inc.:
HIV-1
HIV Seronegativity

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014