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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
  Purpose

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.


Condition Intervention
Insulin Resistance
 Drug: metformin, rosiglitazone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medical Centre Ljubljana:

Primary Outcome Measures:
  • fasting plasma glucose, basal insulin levels [ Time Frame: 48 weeks ]

Secondary Outcome Measures:
  • insulin resistance, beta cell function [ Time Frame: 48 week ]

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483392

Locations
Slovenia
Department of Endocrinology, Diabetes and Metabolic diseases
Ljubljana, Slovenia, 1525
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
Study Chair: Andrej Janez, MD, PhD Department of Endocrinology, Diabetes and Metabolic Diseases, Medical Center Ljubljana, Zaloska 7, 1525 Ljubljana, Slovenia
  More Information

No publications provided by University Medical Centre Ljubljana

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00483392     History of Changes
Other Study ID Numbers: J3-3545, Slovenia grant J3-3545
Study First Received: June 5, 2007
Last Updated: June 5, 2007
Health Authority: Slovenia: Institutional Review Board

Keywords provided by University Medical Centre Ljubljana:
insulin
rosiglitazone
metformin
hiv
protease inhibitors

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Rosiglitazone
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013