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Tracking Information | |||||
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First Received Date † | June 5, 2007 | ||||
Last Updated Date | June 5, 2007 | ||||
Start Date † | |||||
Current Primary Outcome Measures † |
fasting plasma glucose, basal insulin levels [ Time Frame: 48 weeks ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures † |
insulin resistance, beta cell function [ Time Frame: 48 week ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients | ||||
Official Title † | |||||
Brief Summary | The purpose of this study is to evaluate and compare the effects of treatment with rosiglitazone and metformin on insulin resistance in patients infected with Human Immunodeficiency Virus on stable Highly Active Antiretroviral Therapy including a Protease Inhibitor after the period of 48 weeks. |
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Detailed Description | |||||
Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
Condition † | Insulin Resistance | ||||
Intervention † | Drug: metformin, rosiglitazone | ||||
Study Arms / Comparison Groups | |||||
Publications * | Silic A, Janez A, Tomazic J, Karner P, Vidmar L, Sharma P, Maticic M. Effect of rosiglitazone and metformin on insulin resistance in patients infected with human immunodeficiency virus receiving highly active antiretroviral therapy containing protease inhibitor: randomized prospective controlled clinical trial. Croat Med J. 2007 Dec;48(6):791-9. | ||||
* 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 † | |||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Male | ||||
Ages | 18 Years to 60 Years | ||||
Accepts Healthy Volunteers | |||||
Contacts †† | |||||
Location Countries † | Slovenia | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00483392 | ||||
Responsible Party | |||||
Secondary IDs †† | Slovenia grant J3-3545 | ||||
Study Sponsor † | University Medical Centre Ljubljana | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | University Medical Centre Ljubljana | ||||
Verification Date | June 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |