Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2026-03-12 @ 11:14 AM
Study NCT ID:
NCT02530827
Status:
COMPLETED
Last Update Posted:
2015-08-21
First Post:
2015-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Energy Expenditure of People Living With HIV/AIDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D039682', 'term': 'HIV-Associated Lipodystrophy Syndrome'}], 'ancestors': [{'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'}, {'id': 'D008060', 'term': 'Lipodystrophy'}, {'id': 'D012875', 'term': 'Skin Diseases, Metabolic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}, {'id': 'D058607', 'term': 'Fibric Acids'}], 'ancestors': [{'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'urine.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-20', 'studyFirstSubmitDate': '2015-08-04', 'studyFirstSubmitQcDate': '2015-08-20', 'lastUpdatePostDateStruct': {'date': '2015-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Energy Expenditure (kcal/d)', 'timeFrame': '14 day'}, {'measure': 'Resting Energy Expenditure (kcal/d)', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Correlation between doubly labeled water and accelerometer to measure total energy expenditure (ICC, 95% CI)', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['energy expenditure', 'doubly labeled water', 'accelerometer', 'HIV', 'lipodystrophy syndrome.'], 'conditions': ['HIV/AIDS', 'HIV Lipodystrophy Syndrome']}, 'descriptionModule': {'briefSummary': 'Background: Several studies have reported increased resting energy expenditure (REE) in people living with HIV/AIDS possibly due to changes in body composition that occurs in HIV lipodystrophy syndrome.\n\nThe aim of this study was to evaluate the influence of the use of lipid-lowering drugs in resting energy expenditure (REE) and total energy expenditure (TEE) in patients seropositive for HIV in treatment of lipodystrophy.', 'detailedDescription': 'REE was measured by indirect calorimetry.\n\nTEE was measured by doubly labeled water (DLW) technique and an activity monitor based on accelerometry (AM).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Men previously diagnosed with HIV infection, on antiretroviral therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Use of antiretroviral therapy for at least 4 months\n* A cluster of differentiation 4 (CD4) T-cell count of \\>200 cells/mm3\n* Use of lipid-lowering drugs for at least 1 month (group HIV-seropositive with lipodystrophy and use of lipid-lowering)\n\nExclusion Criteria:\n\n* Signs or symptoms of opportunistic infections\n* Thyroid disease'}, 'identificationModule': {'nctId': 'NCT02530827', 'briefTitle': 'Energy Expenditure of People Living With HIV/AIDS', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Influence of Lipid-lowering Drugs in Patients Seropositive for HIV With Lipodystrophy in Resting Energy Expenditure and Total Energy Expenditure', 'orgStudyIdInfo': {'id': 'CAAE 01848612.1.0000.5440'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LIPO-HIPO-', 'description': 'HIV-seropositive without lipodystrophy and no use of lipid-lowering drugs.'}, {'label': 'LIPO+HIPO-', 'description': 'HIV-seropositive with lipodystrophy and no use of lipid-lowering drugs.'}, {'label': 'LIPO+HIPO+', 'description': 'HIV-seropositive with lipodystrophy and use of lipid-lowering drugs.', 'interventionNames': ['Drug: use of lipid-lowering drugs.']}], 'interventions': [{'name': 'use of lipid-lowering drugs.', 'type': 'DRUG', 'otherNames': ['statins and fibrates'], 'description': 'The patients shoud be in use of a lipid-lowering drugs previouly, at least one month before of the begining of the study.', 'armGroupLabels': ['LIPO+HIPO+']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}