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

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.
 
ClinicalTrials.gov Identifier: NCT00309205
Recruitment Status : Completed
First Posted : March 31, 2006
Last Update Posted : September 1, 2009
Sponsor:
Information provided by:
International Partnership for Microbicides, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections HIV-1 Drug: dapivirine (TMC120) vaginal gel Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: 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.
Study Start Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Local and systemic safety and tolerability.

Eligibility Criteria
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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:

  • 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.
Contacts and Locations
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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): NCT00309205


Locations
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Belgium
SGS Biopharma - Research Unit Stuivenberg
Antwerp, Belgium, 2060
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Investigators
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Study Director: Zeda Rosenberg, ScD IPM
More Information
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Responsible Party: Zeda Rosenberg ScD, International Partnership for Microbicides
ClinicalTrials.gov Identifier: NCT00309205    
Other Study ID Numbers: IPM005B
First Posted: March 31, 2006    Key Record Dates
Last Update Posted: September 1, 2009
Last Verified: August 2009
Keywords provided by International Partnership for Microbicides, Inc.:
HIV seronegativity
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Immunologic Deficiency Syndromes
Immune System Diseases
Dapivirine
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents