Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-23 @ 12:43 PM
Study NCT ID:
NCT00564057
Status:
UNKNOWN
Last Update Posted:
2007-12-06
First Post:
2007-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Antihypertensive Treatment in HIV Infected Patients: Candesartan Versus Lercanidipine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D006973', 'term': 'Hypertension'}], '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'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C081643', 'term': 'candesartan'}, {'id': 'C060343', 'term': 'lercanidipine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2009-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-12-05', 'studyFirstSubmitDate': '2007-11-26', 'studyFirstSubmitQcDate': '2007-11-26', 'lastUpdatePostDateStruct': {'date': '2007-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'morpho-functional left ventricle characteristics', 'timeFrame': 'one year'}, {'measure': 'metabolic profile', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'systolic and diastolic blood pressure', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'blood pressure', 'left ventricle', 'metabolic profile', 'treatment experienced'], 'conditions': ['HIV Infections', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '15903292', 'type': 'BACKGROUND', 'citation': 'Grinspoon SK. Metabolic syndrome and cardiovascular disease in patients with human immunodeficiency virus. Am J Med. 2005 Apr;118 Suppl 2:23S-28S. doi: 10.1016/j.amjmed.2005.01.047.'}, {'pmid': '12817187', 'type': 'BACKGROUND', 'citation': 'Gazzaruso C, Bruno R, Garzaniti A, Giordanetti S, Fratino P, Sacchi P, Filice G. Hypertension among HIV patients: prevalence and relationships to insulin resistance and metabolic syndrome. J Hypertens. 2003 Jul;21(7):1377-82. doi: 10.1097/01.hjh.0000059071.43904.dc.'}, {'pmid': '14627784', 'type': 'BACKGROUND', 'citation': "Friis-Moller N, Sabin CA, Weber R, d'Arminio Monforte A, El-Sadr WM, Reiss P, Thiebaut R, Morfeldt L, De Wit S, Pradier C, Calvo G, Law MG, Kirk O, Phillips AN, Lundgren JD; Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group. Combination antiretroviral therapy and the risk of myocardial infarction. N Engl J Med. 2003 Nov 20;349(21):1993-2003. doi: 10.1056/NEJMoa030218."}, {'pmid': '12131567', 'type': 'BACKGROUND', 'citation': 'Meng Q, Lima JA, Lai H, Vlahov D, Celentano DD, Strathdee S, Nelson KE, Tong W, Lai S. Use of HIV protease inhibitors is associated with left ventricular morphologic changes and diastolic dysfunction. J Acquir Immune Defic Syndr. 2002 Jul 1;30(3):306-10. doi: 10.1097/00126334-200207010-00006.'}, {'pmid': '12872052', 'type': 'BACKGROUND', 'citation': 'Lindholm LH, Persson M, Alaupovic P, Carlberg B, Svensson A, Samuelsson O. Metabolic outcome during 1 year in newly detected hypertensives: results of the Antihypertensive Treatment and Lipid Profile in a North of Sweden Efficacy Evaluation (ALPINE study). J Hypertens. 2003 Aug;21(8):1563-74. doi: 10.1097/01.hjh.0000084723.53355.76.'}]}, 'descriptionModule': {'briefSummary': 'Human immunodeficiency virus infection and highly active antiretroviral therapy (HAART) are associated with an increased risk of cardiovascular disease: a wide range of alterations in lipid and glucose metabolism has been increasingly recognized in HIV patients treated with HAART. Few data are available on the effects of antihypertensive treatment on cardiac morpho-functional characteristics and metabolic parameters in HIV patients. Aim of the study is to assess the effects of chronic therapy with angiotensin receptor blocker(candesartan)or calcium channel blocker (lercanidipine)on metabolic profile and cardiac remodelling in HIV hypertensive patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV infection\n* office blood pressure \\> 140/90 mmHg\n* no antihypertensive treatment\n* good quality echocardiogram\n\nExclusion Criteria:\n\n* cardiovascular diseases\n* hypothyroidism\n* diabetes\n* secondary hypertension\n* hepatic and renal failure'}, 'identificationModule': {'nctId': 'NCT00564057', 'briefTitle': 'Effects of Antihypertensive Treatment in HIV Infected Patients: Candesartan Versus Lercanidipine', 'organization': {'class': 'OTHER', 'fullName': "Università degli Studi dell'Insubria"}, 'officialTitle': 'Effects of Antihypertensive Treatment on Cardiac Remodelling and Metabolic Profile in HIV Infected Patients: Randomized Longitudinal Study With Candesartan Versus Lercanidipine', 'orgStudyIdInfo': {'id': '44758'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'candesartan 8-16 mg once daily', 'interventionNames': ['Drug: candesartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'lercanidipine 10-20 mg once daily', 'interventionNames': ['Drug: lercanidipine']}], 'interventions': [{'name': 'candesartan', 'type': 'DRUG', 'description': 'tablet 8-16 mg once daily, one year', 'armGroupLabels': ['1']}, {'name': 'lercanidipine', 'type': 'DRUG', 'description': 'tablets 10-20 mg once daily, one year', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21100', 'city': 'Varese', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'University of Insubria, Department of Clinical Medicine', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}], 'centralContacts': [{'name': 'anna maria grandi, MD', 'role': 'CONTACT', 'email': 'amgrandi@libero.it', 'phone': '+39 0332 278403'}], 'overallOfficials': [{'name': 'anna maria grandi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Insubria, Varese, ITALY'}, {'name': 'paolo grossi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Insubria, Varese, Italy'}, {'name': 'andrea maria maresca, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Insubria, Varese, Italy'}, {'name': 'eleonora nicolini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Insubria, Varese, Italy'}, {'name': 'massimo giola, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Insubria, Varese, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Università degli Studi dell'Insubria", 'class': 'OTHER'}}}}