Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 12:49 PM
Study NCT ID:
NCT01301066
Status:
COMPLETED
Last Update Posted:
2014-04-29
First Post:
2011-02-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects
Sponsor:
Organization:
Raw JSON
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PI may publish, however PI must submit publication to sponsor for review at least 60 days prior to proposed publication. Sponsor may remove any information that is considered confidential and/or proprietary.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pitavastatin 4 mg QD', 'description': 'Pitavastatin: Pitavastatin 4 mg QD', 'otherNumAtRisk': 126, 'otherNumAffected': 10, 'seriousNumAtRisk': 126, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Pravastatin 40 mg QD', 'description': 'Pravastatin: Pravastatin 40 mg QD', 'otherNumAtRisk': 126, 'otherNumAffected': 5, 'seriousNumAtRisk': 126, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Upper abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Blood CK increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}], 'seriousEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Enterovesical fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Herpes dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Multiple fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Muscle haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '1.6'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitavastatin 4 mg QD', 'description': 'Pitavastatin: Pitavastatin 4 mg QD'}, {'id': 'OG001', 'title': 'Pravastatin 40 mg QD', 'description': 'Pravastatin: Pravastatin 40 mg QD'}], 'classes': [{'categories': [{'measurements': [{'value': '155.1', 'spread': '25.93', 'groupId': 'OG000'}, {'value': '154.6', 'spread': '23.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks minus baseline', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent To Treat (mITT) population included all randomized subjects who received at least 1 dose of study drug and had at least 1 on-treatment lipid assessment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pitavastatin 4 mg QD', 'description': 'Pitavastatin: Pitavastatin 4 mg QD'}, {'id': 'FG001', 'title': 'Pravastatin 40 mg QD', 'description': 'Pravastatin: Pravastatin 40 mg QD'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '126'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pitavastatin 4 mg QD', 'description': 'Pitavastatin: Pitavastatin 4 mg QD'}, {'id': 'BG001', 'title': 'Pravastatin 40 mg QD', 'description': 'Pravastatin: Pravastatin 40 mg QD'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 252}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-27', 'studyFirstSubmitDate': '2011-02-18', 'resultsFirstSubmitDate': '2014-02-10', 'studyFirstSubmitQcDate': '2011-02-22', 'lastUpdatePostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-27', 'studyFirstPostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks', 'timeFrame': '12 weeks minus baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dyslipidemia']}, 'referencesModule': {'references': [{'pmid': '28416195', 'type': 'DERIVED', 'citation': 'Aberg JA, Sponseller CA, Ward DJ, Kryzhanovski VA, Campbell SE, Thompson MA. Pitavastatin versus pravastatin in adults with HIV-1 infection and dyslipidaemia (INTREPID): 12 week and 52 week results of a phase 4, multicentre, randomised, double-blind, superiority trial. Lancet HIV. 2017 Jul;4(7):e284-e294. doi: 10.1016/S2352-3018(17)30075-9. Epub 2017 Apr 13.'}, {'pmid': '28252528', 'type': 'DERIVED', 'citation': 'Toribio M, Fitch KV, Sanchez L, Burdo TH, Williams KC, Sponseller CA, McCurdy Pate M, Aberg JA, Zanni MV, Grinspoon SK. Effects of pitavastatin and pravastatin on markers of immune activation and arterial inflammation in HIV. AIDS. 2017 Mar 27;31(6):797-806. doi: 10.1097/QAD.0000000000001427.'}, {'pmid': '28121706', 'type': 'DERIVED', 'citation': "Joshi PH, Miller PE, Martin SS, Jones SR, Massaro JM, D'Agostino RB Sr, Kulkarni KR, Sponseller C, Toth PP. Greater remnant lipoprotein cholesterol reduction with pitavastatin compared with pravastatin in HIV-infected patients. AIDS. 2017 Apr 24;31(7):965-971. doi: 10.1097/QAD.0000000000001423."}]}, 'descriptionModule': {'briefSummary': 'A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females (non-pregnant, non-lactating females) 18-70 years of age, inclusive, at time of consent.\n* Both men and women of child bearing potential (i.e., not surgically sterile or post-menopausal defined as age \\>40 years without menses for ≥2 years) must agree to use at least 2 reliable forms of contraception\n* Documented HIV infection.\n\nExclusion Criteria:\n\n* Homozygous familial hypercholesterolemia\n* Any conditions that may cause secondary dyslipidemia\n* History of coronary artery disease (CAD) or CAD equivalent'}, 'identificationModule': {'nctId': 'NCT01301066', 'briefTitle': 'A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kowa Research Institute, Inc.'}, 'officialTitle': 'A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects With Dyslipidemia, Followed by a 40-Week Safety Extension Study', 'orgStudyIdInfo': {'id': 'NK-104-4.05US'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pitavastatin 4 mg QD', 'interventionNames': ['Drug: Pitavastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pravastatin 40 mg QD', 'interventionNames': ['Drug: Pravastatin']}], 'interventions': [{'name': 'Pitavastatin', 'type': 'DRUG', 'otherNames': ['Livalo'], 'description': 'Pitavastatin 4 mg QD', 'armGroupLabels': ['Pitavastatin 4 mg QD']}, {'name': 'Pravastatin', 'type': 'DRUG', 'description': 'Pravastatin 40 mg QD', 'armGroupLabels': ['Pravastatin 40 mg QD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'city': 'Ft. 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