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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
International Partnership for Microbicides, Inc.


Information provided by (Responsible Party)
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier
NCT00304642

First received: March 16, 2006
Last updated: June 1, 2006
Last Verified: June 2006
History of Changes
Purpose

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
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.

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.

Enrollment: 18
Study Start Date: November 2005

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 50 Years  
Sexes 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

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

More Information


Responsible Party: International Partnership for Microbicides, Inc.  
ClinicalTrials.gov Identifier: NCT00304642   History of Changes  
Other Study ID Numbers: IPM004  
Study First Received: March 16, 2006  
Last Updated: June 1, 2006  

Keywords provided by International Partnership for Microbicides, Inc.:

HIV-1
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Anti-Infective Agents

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.