Safety and Feasibility Study of Dapivirine (TMC120) Vaginal Ring in Belgium

This study has been completed.
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by:
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT00332995
First received: June 1, 2006
Last updated: August 31, 2009
Last verified: August 2009

June 1, 2006
August 31, 2009
July 2005
Not Provided
  • Safety and tolerability of seven-day use of a vaginal ring containing dapivirine (TMC120).
  • Assess dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma during and after seven-day use of a vaginal ring containing dapivirine (TMC120).
Same as current
Complete list of historical versions of study NCT00332995 on ClinicalTrials.gov Archive Site
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Safety and Feasibility Study of Dapivirine (TMC120) Vaginal Ring in Belgium
Double-blind, Randomized, Placebo Controlled Trial to Study Safety, Local and Systemic Availability of TMC120 From a Vaginal Ring.

This Phase I trial will assess the feasibility of using a vaginal ring to deliver the candidate microbicide dapivirine (TMC120) for 7 days. The study population will consist of 13 healthy, sexually abstinent women. Safety and tolerability will be assessed through clinical and laboratory assessments. Feasibility of drug delivery will be assessed by measuring dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
HIV Infections
Drug: dapivirine (TMC120) vaginal ring
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
August 2005
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Inclusion Criteria:

  • Female, age 18-50 years
  • Willing and able to provide written informed consent
  • HIV-uninfected and otherwise healthy
  • Willing to abstain from sexual activity and from use of vaginal products while participating in the study
  • Currently using oral contraceptives for pregnancy prevention
  • Willing to use oral contraceptives as needed to avoid menstruation while taking part in this study

Exclusion Criteria:

  • History of allergy to TMC120 or to the constituents of the vaginal ring
  • History of diagnosis of and/or treatment for a sexually transmitted disease within the last three months
  • History of genital tract surgery within the last month
  • Currently pregnant or breastfeeding, or within two months of last pregnancy outcome
  • Currently or within one month of participating in any other clinical research study
  • Current vulvar or vaginal symptoms / abnormalities that could influence the study results
  • Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption
  • Current diagnosis of any genital infection
  • Smoking more than 10 cigarettes / day
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00332995
IPM008, TMC120-C131
Not Provided
Zeda Rosenberg ScD, International Partnership for Microbicides
International Partnership for Microbicides, Inc.
Tibotec Pharmaceutical Limited
Principal Investigator: Dr. Luc Van Bortel University of Ghent
International Partnership for Microbicides, Inc.
August 2009

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