Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 12:34 AM
Study NCT ID:
NCT00117494
Status:
COMPLETED
Last Update Posted:
2011-12-22
First Post:
2005-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rosuvastatin Versus Pravastatin in HIV Patients Treated With Boosted Protease Inhibitors (PI) (ANRS126)
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': 'D017035', 'term': 'Pravastatin'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-21', 'studyFirstSubmitDate': '2005-06-30', 'studyFirstSubmitQcDate': '2005-06-30', 'lastUpdatePostDateStruct': {'date': '2011-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the change in LDL cholesterol between D0 and D45, in patients receiving rosuvastatin (10 mg/day) or pravastatin (40 mg/day) and treated by antiretroviral agents including a boosted protease inhibitor on D45.'}], 'secondaryOutcomes': [{'measure': 'Changes in triglycerides and HDL cholesterol on D45'}, {'measure': 'Percentage of patients with a normal value of LDL cholesterol, HDL cholesterol and triglycerides on D45 Clinical and biological safety parameters of rosuvastatin and pravastatin'}, {'measure': 'Distribution profile of the diameter of LDL cholesterol particles'}, {'measure': 'Cmin of rosuvastatin and pravastatin on D15'}, {'measure': 'Cmin of protease inhibitors on D15.'}]}, 'conditionsModule': {'keywords': ['Hyperlipidemia', 'HIV infections', 'STATINS, HMG-COA', 'Protease Inhibitor', 'Treatment Experienced'], 'conditions': ['Hyperlipidemia', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '22739396', 'type': 'DERIVED', 'citation': 'Bittar R, Giral P, Aslangul E, Assoumou L, Valantin MA, Kalmykova O, Federspiel MC, Cherfils C, Costagliola D, Bonnefont-Rousselot D; French National Agency for AIDS and Viral Hepatitis Research (ANRS) 126 study group. Effects of rosuvastatin versus pravastatin on low-density lipoprotein diameter in HIV-1-infected patients receiving ritonavir-boosted protease inhibitor. AIDS. 2012 Sep 10;26(14):1801-5. doi: 10.1097/QAD.0b013e328357063c.'}, {'pmid': '22318219', 'type': 'DERIVED', 'citation': 'Bittar R, Giral P, Aslangul E, Assoumou L, Valantin MA, Kalmykova O, Fesel-Fouquier V, Costagliola D, Bonnefont-Rousselot D; ANRS 126 study group. Determinants of low-density lipoprotein particle diameter during antiretroviral therapy including protease inhibitors in HIV-1-infected patients. Antivir Ther. 2012;17(5):855-60. doi: 10.3851/IMP2065. Epub 2012 Feb 9.'}]}, 'descriptionModule': {'briefSummary': 'In HIV hypercholesterolemic patients treated with protease inhibitors, some drugs of the statin group are used to control cholesterol level. New and potentially more efficient statins may interfere with protease inhibitors and hence loose a part of their activity. They have thus to be compared with a more established drug of the same class (e.g. pravastatin). The protocol compares the efficacy and safety of rosuvastatin and pravastatin.', 'detailedDescription': 'The study compares the efficacy and safety of rosuvastatin and pravastatin among dyslipidemic HIV-seropositive patients treated with antiretroviral agents including a boosted protease inhibitor.\n\nIt is an open, multicenter, randomised trial, with two parallel groups comparing rosuvastatin with pravastatin.\n\nStatins are administered from D0, with a single daily dose in the morning, for 45 consecutive days.\n\nThe duration of the study for each patient will be 45 days not including the preselection period (maximum 15 days).\n\nThe primary end-point compares the change in LDL cholesterol between D0 and D45, in patients receiving rosuvastatin (10 mg/day) or pravastatin (40 mg/day) and treated by antiretroviral agents including a boosted Protease Inhibitor.\n\nSecondary end-points compares changes in triglycerides and HDL cholesterol; percentage of patients with a normal value of LDL cholesterol, HDL cholesterol and triglycerides on D45; clinical safety and laboratory safety parameters of rosuvastatin and pravastatin; distribution profile of the diameter of LDL cholesterol particles.\n\nCmin of rosuvastatin, pravastatin and protease inhibitors (PI) are controlled at D15 for statins and PI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fasting LDL cholesterol over 4.1 mmol/L (1.6 g/l)\n* Blood triglycerides over 8.8 mmol/L (8 g/l)\n* HIV-1 infection\n* Viral load above or equal to 10.000 copies/ml\n* Stable antiretroviral regimen for past two months\n\nExclusion Criteria:\n\n* Coronary disease\n* Genetic muscular disease\n* CPK over 5N\n* Hepatic or renal insufficiency\n* Alcohol intake more than 40g/d\n* Hypothyroidism\n* Pregnancy and breast feeding'}, 'identificationModule': {'nctId': 'NCT00117494', 'briefTitle': 'Rosuvastatin Versus Pravastatin in HIV Patients Treated With Boosted Protease Inhibitors (PI) (ANRS126)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'French National Agency for Research on AIDS and Viral Hepatitis'}, 'officialTitle': 'Randomised Comparative Study of the Efficacy and Safety of Rosuvastatin and Pravastatin in Dyslipidemic Patients Treated With Antiretroviral Agents. Anrs 126', 'orgStudyIdInfo': {'id': '2005-001451-38'}, 'secondaryIdInfos': [{'id': 'ANRS 126'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Pravastatin', 'type': 'DRUG'}, {'name': 'Rosuvastatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75004', 'city': 'Paris', 'country': 'France', 'facility': 'service de Médecine Interne Hopital Hotel Dieu', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Elisabeth Aslangul, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Hôtel Dieu Paris'}, {'name': 'Dominique Costagliola', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Inserm U720 Paris Pitié Salpétrière'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French National Agency for Research on AIDS and Viral Hepatitis', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}