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Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients

This study has been completed.
Sponsor:
Information provided by:
University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT00483392
First received: June 5, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted

June 5, 2007
June 5, 2007
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fasting plasma glucose, basal insulin levels [ Time Frame: 48 weeks ]
Same as current
No Changes Posted
insulin resistance, beta cell function [ Time Frame: 48 week ]
Same as current
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Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients
Not Provided

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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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Insulin Resistance
Drug: metformin, rosiglitazone
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria:

  • documented HIV infection
  • stable Protease Inhibitor containing HAART regimen for at least 12 months
  • impaired glucose tolerance
  • elevated insulin levels (above 20 mIU/l)

Exclusion Criteria:

  • patients already taking oral hypoglycaemic treatment or insulin
  • heart failure NYHA I-IV
  • liver disease or kidney disease
  • elevated AST or ALT above 2 times upper normal range
  • elevated creatinine (above 150 mmol/l)
Male
18 Years to 60 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Slovenia
 
NCT00483392
J3-3545, Slovenia grant J3-3545
No
Not Provided
University Medical Centre Ljubljana
Not Provided
Study Chair: Andrej Janez, MD, PhD Department of Endocrinology, Diabetes and Metabolic Diseases, Medical Center Ljubljana, Zaloska 7, 1525 Ljubljana, Slovenia
University Medical Centre Ljubljana
June 2007

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