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A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in Belgium

This study has been completed.
Sponsor:
Information provided by:
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT00309205
First received: March 30, 2006
Last updated: August 31, 2009
Last verified: August 2009

March 30, 2006
August 31, 2009
December 2005
Not Provided
Local and systemic safety and tolerability.
Same as current
Complete list of historical versions of study NCT00309205 on ClinicalTrials.gov Archive Site
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A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in Belgium
A Phase I/II Single-Centre Double-Blinded Randomized Study of the Safety and Tolerability of TMC120 Vaginal Microbicide Gel vs. HEC-Based Universal Placebo Gel in Healthy HIV-Negative Women.

Approximately 36 HIV-negative women, aged >18 and < 50, will be enrolled in this study. Each volunteer will have a 2:1 chance of receiving dapivirine gel versus placebo. The volunteers will receive investigational product for a total of 42 days.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • HIV Infections
  • HIV-1
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
36
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Inclusion Criteria:

  • HIV-negative
  • Willing to participate and sign an informed consent form
  • Willing to be tested for HIV, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group.
  • Willing to use two forms of contraception during the study
  • Willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study.
  • Have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses

Exclusion Criteria:

  • Currently pregnant or breast-feeding
  • Clinically detectable genital abnormality on the vulva, vaginal walls or cervix
  • Laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed GUD or active HSV-2 lesion
  • Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization
  • Symptomatic bacterial vaginosis at Screening and unwilling to undergo treatment.
  • Women who require treatment for tuberculosis (TB) within 21 days prior to randomization.
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00309205
IPM005B
Not Provided
Zeda Rosenberg ScD, International Partnership for Microbicides
International Partnership for Microbicides, Inc.
Not Provided
Study Director: Zeda Rosenberg, ScD IPM
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