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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00332995
First Posted: June 2, 2006
Last Update Posted: September 1, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by:
International Partnership for Microbicides, Inc.
  Purpose
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Double-blind, Randomized, Placebo Controlled Trial to Study Safety, Local and Systemic Availability of TMC120 From a Vaginal Ring.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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).

Estimated Enrollment: 13
Study Start Date: July 2005
Estimated Study Completion Date: August 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00332995


Locations
Belgium
Drug Research Unit Gent
Gent, Belgium, 9000
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Tibotec Pharmaceutical Limited
Investigators
Principal Investigator: Dr. Luc Van Bortel University of Ghent
  More Information

Responsible Party: Zeda Rosenberg ScD, International Partnership for Microbicides
ClinicalTrials.gov Identifier: NCT00332995     History of Changes
Other Study ID Numbers: IPM008, TMC120-C131
First Submitted: June 1, 2006
First Posted: June 2, 2006
Last Update Posted: September 1, 2009
Last Verified: August 2009

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases


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