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Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00483392
First Posted: June 7, 2007
Last Update Posted: June 7, 2007
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.
Information provided by:
University Medical Centre Ljubljana
June 5, 2007
June 7, 2007
June 7, 2007
Not Provided
Not Provided
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
Not Provided
Not Provided
 
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.
Not Provided
Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Not Provided
Not Provided
Not Provided

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)
Sexes Eligible for Study: Male
18 Years to 60 Years   (Adult)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Slovenia
 
 
NCT00483392
J3-3545
Slovenia grant J3-3545
No
Not Provided
Not Provided
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