Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-01-07 @ 7:24 AM
Study NCT ID:
NCT00483392
Status:
COMPLETED
Last Update Posted:
2007-06-07
First Post:
2007-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C471074', 'term': 'rosiglitazone-metformin combination'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'lastUpdateSubmitDate': '2007-06-05', 'studyFirstSubmitDate': '2007-06-05', 'studyFirstSubmitQcDate': '2007-06-05', 'lastUpdatePostDateStruct': {'date': '2007-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fasting plasma glucose, basal insulin levels', 'timeFrame': '48 weeks'}], 'secondaryOutcomes': [{'measure': 'insulin resistance, beta cell function', 'timeFrame': '48 week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['insulin', 'rosiglitazone', 'metformin', 'hiv', 'protease inhibitors'], 'conditions': ['Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '18074413', 'type': 'DERIVED', 'citation': '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. doi: 10.3325/cmj.2007.6.791.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* documented HIV infection\n* stable Protease Inhibitor containing HAART regimen for at least 12 months\n* impaired glucose tolerance\n* elevated insulin levels (above 20 mIU/l)\n\nExclusion Criteria:\n\n* patients already taking oral hypoglycaemic treatment or insulin\n* heart failure NYHA I-IV\n* liver disease or kidney disease\n* elevated AST or ALT above 2 times upper normal range\n* elevated creatinine (above 150 mmol/l)'}, 'identificationModule': {'nctId': 'NCT00483392', 'briefTitle': 'Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'orgStudyIdInfo': {'id': 'J3-3545'}, 'secondaryIdInfos': [{'id': 'Slovenia grant J3-3545'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'metformin, rosiglitazone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1525', 'city': 'Ljubljana', 'state': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Department of Endocrinology, Diabetes and Metabolic diseases', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Andrej Janez, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Endocrinology, Diabetes and Metabolic Diseases, Medical Center Ljubljana, Zaloska 7, 1525 Ljubljana, Slovenia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}}}}