Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-31 @ 10:36 AM
Study NCT ID:
NCT00843661
Status:
UNKNOWN
Last Update Posted:
2011-08-02
First Post:
2009-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'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': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'D011345', 'term': 'Fenofibrate'}, {'id': 'D017035', 'term': 'Pravastatin'}], 'ancestors': [{'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D058607', 'term': 'Fibric Acids'}, {'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': 'D001577', 'term': 'Benzophenones'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-08-01', 'studyFirstSubmitDate': '2009-02-12', 'studyFirstSubmitQcDate': '2009-02-12', 'lastUpdatePostDateStruct': {'date': '2011-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'per cent changes of LDL cholesterol, comparison between the 2 treatment regimens', 'timeFrame': 'After 6 month treatment'}]}, 'conditionsModule': {'keywords': ['Treatment Experienced'], 'conditions': ['HIV', 'Hyperlipidemia', 'HIV Infections']}, 'descriptionModule': {'briefSummary': '* The aim of the study is to compare the effects of coadministration of ezetimibe 10 mg/die + fenofibrate 200 mg/die versus pravastatin 40 mg/die monotherapy in HIV-infected patients treated with protease inhibitors.\n* Single-centre, open, randomized, controlled, prospective pilot study.\n* 60 patients will be enrolled in order to reach the target of 50 patients evaluable at the end of the study. The patients will be randomly assigned to a 6-month treatment with ezetimibe+fenofibrate or with pravastatin.The visit will be every month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients older than 18 years\n* documented positive HIV antibodies test\n* on stable therapy with PIs for at least 12 months\n* LDL-cholesterol \\>130 mg/dl or triglycerides 200 - 500 mg/dl with non-HDL cholesterol \\>160 mg/dl\n* unresponsive to dietary measures and regular physical exercise of at\n\nExclusion Criteria:\n\n* history of dyslipidemia before antiretroviral therapy\n* cardiovascular and cerebrovascular diseases\n* Cushing's syndrome\n* concurrent therapy with lipid-lowering agents, oral anticoagulant, estrogens, thiazidic diuretics, beta-blockers\n* hypothyroidism\n* Type 1 diabetes mellitus\n* renal failure"}, 'identificationModule': {'nctId': 'NCT00843661', 'briefTitle': 'Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale di Circolo - Fondazione Macchi'}, 'officialTitle': 'Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients Receiving Protease Inhibitors: a Randomized, Prospective, Controlled Pilot Study.', 'orgStudyIdInfo': {'id': 'EFP01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ezetimibe and fenofibrate', 'interventionNames': ['Drug: ezetimibe', 'Drug: fenofibrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pravastatin', 'interventionNames': ['Drug: pravastatin']}], 'interventions': [{'name': 'ezetimibe', 'type': 'DRUG', 'description': '10 mg ezetimibe/day', 'armGroupLabels': ['Ezetimibe and fenofibrate']}, {'name': 'fenofibrate', 'type': 'DRUG', 'description': '200 mg fenofibrate/day', 'armGroupLabels': ['Ezetimibe and fenofibrate']}, {'name': 'pravastatin', 'type': 'DRUG', 'description': '40 mg pravastatin/day', 'armGroupLabels': ['Pravastatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21100', 'city': 'Varese', 'state': 'Varese', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anna Maria Grandi, MD', 'role': 'CONTACT', 'email': 'amgrandi@libero.it', 'phone': '+390332278403'}], 'facility': 'Ospedale di Circolo and Fondazione Macchi', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}], 'centralContacts': [{'name': 'Anna Maria Grandi, MD', 'role': 'CONTACT', 'email': 'amgrandi@libero.it', 'phone': '+390332278403'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale di Circolo - Fondazione Macchi', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Anna Maria Grandi', 'oldOrganization': 'Ospedale di Circolo Fondazione MAcchi'}}}}