Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 1:06 AM
Study NCT ID:
NCT00135434
Status:
COMPLETED
Last Update Posted:
2011-04-08
First Post:
2005-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069446', 'term': 'Atazanavir Sulfate'}, {'id': 'C558899', 'term': 'lopinavir-ritonavir drug combination'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-07', 'studyFirstSubmitDate': '2005-08-25', 'studyFirstSubmitQcDate': '2005-08-25', 'lastUpdatePostDateStruct': {'date': '2011-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin sensitivity by euglycemic hyperinsulinemic clamp method'}], 'secondaryOutcomes': [{'measure': 'Insulin sensitivity by oral glucose tolerance'}, {'measure': 'Lipids and lipoproteins'}]}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'This study examined the effects of two commonly prescribed HIV drugs on the way the body metabolizes glucose, insulin and fat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers'}, 'identificationModule': {'nctId': 'NCT00135434', 'briefTitle': 'Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism', 'orgStudyIdInfo': {'id': 'AI424-130'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Atazanavir/Ritonavir/Lopinavir/ritonavir', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08690', 'city': 'Hamilton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Clinical Pharmacology Unit, Bristol-Myers Squibb Company', 'geoPoint': {'lat': 40.20706, 'lon': -74.08125}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Bristol-Myers Squibb'}}}}