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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT00304668
First received: March 17, 2006
Last updated: May 24, 2006
Last verified: May 2006

March 17, 2006
May 24, 2006
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Local and systemic safety and tolerability.
Same as current
Complete list of historical versions of study NCT00304668 on ClinicalTrials.gov Archive Site
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A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in South Africa
A Phase I/II Single-Centre Double-Blinded Randomized Study of the Safety and Tolerability of TMC120 Vaginal Microbicide Gel (TMC120 Gel-002) Vs. HEC-Based Universal Placebo Gel in Healthy HIV-Negative Women.

Approximately 42 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-002 versus placebo. The volunteers will receive investigational product for a total of 42 days.

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Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
HIV Infections
Drug: dapivirine (TMC120) vaginal gel
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
42
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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
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NCT00304668
IPM005A
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International Partnership for Microbicides, Inc.
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Study Director: Zeda Rosenberg, ScD IPM
International Partnership for Microbicides, Inc.
May 2006

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