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Tracking Information | |||||
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First Received Date † | March 30, 2006 | ||||
Last Updated Date | July 24, 2006 | ||||
Start Date † | December 2005 | ||||
Current Primary Outcome Measures † |
Local and systemic safety and tolerability. | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00309205 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in Belgium | ||||
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. | ||||
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. |
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Detailed Description | |||||
Study Phase | Phase I, Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study | ||||
Condition † |
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Intervention † | Drug: dapivirine (TMC120) vaginal gel | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 36 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 18 Years to 50 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | Belgium | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00309205 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | International Partnership for Microbicides, Inc. | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | International Partnership for Microbicides, Inc. | ||||
Verification Date | June 2006 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |