Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2026-02-20 @ 6:03 PM
Study NCT ID:
NCT00976950
Status:
COMPLETED
Last Update Posted:
2014-03-20
First Post:
2009-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Post Marketing Surveillance Study Assessing the Long-term Efficacy and Safety of Aptivus Co-administered With Low-dose Ritonavir in Treatment Experienced Patients With HIV-1 Infection in the Daily Clinical Practice.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C107201', 'term': 'tipranavir'}, {'id': 'D019438', 'term': 'Ritonavir'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Aptivus and Ritonavir', 'description': 'ARV means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir', 'otherNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients Reporting Adverse Events (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aptivus and Ritonavir', 'description': 'TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir'}], 'classes': [{'title': 'Patients with any adverse events', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Patients with any serious adverse events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Patients with AE leading to discontinuation', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Patients with hepatic adverse events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Patients with dyslipidemia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': 'Any type of adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS), defined as patients treated with Aptivus'}, {'type': 'SECONDARY', 'title': 'Virologic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aptivus and Ritonavir', 'description': 'TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir'}], 'classes': [{'title': 'Virologic response - Yes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Virologic response - No', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Virologic response - Missing', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': 'Virologic response is defined as HIV viral load of \\< 50 copies/mL before week 48 and without subsequent rebound or change of ARV therapy prior to week 48. A rebound is defined by two consecutive measurements of VL \\>= 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL\\< 50 copies/ml. Because of many missing data concerning the viral load, the virologic response could be determined only for four patients.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS), defined as patients treated with Aptivus'}, {'type': 'SECONDARY', 'title': 'Change in CD4+ Cell Count From Baseline at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aptivus and Ritonavir', 'description': 'TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir'}], 'classes': [{'categories': [{'measurements': [{'value': '85.8', 'spread': '29.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 weeks', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set with with non-missing data at the visit'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aptivus and Ritonavir', 'description': 'TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Events with no relationship to Aptivus', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Aptivus and Ritonavir', 'description': 'TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.5', 'spread': '10.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Age is available for 41 patients.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline HIV RNA values', 'classes': [{'title': '<= 50 copies/ml', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '51 - <1,000 copies/ml', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': '1,000 - <10,000 copies/ml', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': '10,000 - <100,000 copies/ml', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': '100,000 - <1,000,000 copies/ml', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': '>= 1,000,000 copies/ml', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline CD4+ count', 'classes': [{'title': '<= 50 cells/mm^3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': '51 - <251 cells/mm^3', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': '251 - <451 cells/mm^3', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': '>= 451 cells/mm^3', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-24', 'studyFirstSubmitDate': '2009-09-14', 'resultsFirstSubmitDate': '2012-05-30', 'studyFirstSubmitQcDate': '2009-09-14', 'lastUpdatePostDateStruct': {'date': '2014-03-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-09', 'studyFirstPostDateStruct': {'date': '2009-09-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients Reporting Adverse Events (AE)', 'timeFrame': '48 weeks', 'description': 'Any type of adverse events'}], 'secondaryOutcomes': [{'measure': 'Virologic Response', 'timeFrame': '48 weeks', 'description': 'Virologic response is defined as HIV viral load of \\< 50 copies/mL before week 48 and without subsequent rebound or change of ARV therapy prior to week 48. A rebound is defined by two consecutive measurements of VL \\>= 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL\\< 50 copies/ml. Because of many missing data concerning the viral load, the virologic response could be determined only for four patients.'}, {'measure': 'Change in CD4+ Cell Count From Baseline at Week 48', 'timeFrame': '48 weeks'}]}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The aim of this trial is to evaluate the safety and virological and immunological efficacy of Aptivus in treatment-experienced patients with advanced HIV-1 infection who had developed resistance to more than one protease inhibitor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. HIV-1 infected patients who are treatment experienced and infected with HIV-1 strains resistant to more than one protease inhibitor and no other therapeutic options.\n2. The inclusion criteria follow the same criteria which are describe in the newest SPC\n\nExclusion criteria:\n\nThe exclusion criteria follow the same criteria which are describe in the newest SPC'}, 'identificationModule': {'nctId': 'NCT00976950', 'briefTitle': 'A Post Marketing Surveillance Study Assessing the Long-term Efficacy and Safety of Aptivus Co-administered With Low-dose Ritonavir in Treatment Experienced Patients With HIV-1 Infection in the Daily Clinical Practice.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Post Marketing Surveillance Study Assessing the Long-term Efficacy and Safety of Tipranavir (Aptivus®) Co-administered With Low-dose Ritonavir in Treatment Experienced Patients With HIV-1 Infection in the Daily Clinical Practice.', 'orgStudyIdInfo': {'id': '1182.147'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with HIV-1 infection', 'interventionNames': ['Drug: Tipranavir', 'Drug: ritonavir']}], 'interventions': [{'name': 'Tipranavir', 'type': 'DRUG', 'armGroupLabels': ['Patients with HIV-1 infection']}, {'name': 'ritonavir', 'type': 'DRUG', 'description': 'low-dose', 'armGroupLabels': ['Patients with HIV-1 infection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Arad', 'country': 'Romania', 'facility': 'Boehringer Ingelheim Investigational site 9', 'geoPoint': {'lat': 46.18333, 'lon': 21.31667}}, {'city': 'Bacau', 'country': 'Romania', 'facility': 'Boehringer Ingelheim Investigational site 13', 'geoPoint': {'lat': 46.56718, 'lon': 26.91384}}, {'city': 'Brasov', 'country': 'Romania', 'facility': 'Boehringer Ingelheim Investigational site 17', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'city': 'Brasov', 'country': 'Romania', 'facility': 'Boehringer Ingelheim Investigational site 18', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'city': 'Brasov', 'country': 'Romania', 'facility': 'Boehringer Ingelheim Investigational site 19', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Boehringer Ingelheim Investigational site 1', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Boehringer Ingelheim Investigational site 2', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Boehringer Ingelheim Investigational site 3', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Boehringer Ingelheim Investigational site 4', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Boehringer Ingelheim Investigational site 5', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Boehringer Ingelheim Investigational site 6', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Boehringer Ingelheim Investigational site 7', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Boehringer Ingelheim Investigational site 8', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Constanța', 'country': 'Romania', 'facility': 'Boehringer Ingelheim Investigational site 16', 'geoPoint': {'lat': 44.18073, 'lon': 28.63432}}, {'city': 'Craiova', 'country': 'Romania', 'facility': 'Boehringer Ingelheim Investigational site 11', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'city': 'Craiova', 'country': 'Romania', 'facility': 'Boehringer Ingelheim Investigational site 12', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'city': 'Galati', 'country': 'Romania', 'facility': 'Boehringer Ingelheim Investigational site 15', 'geoPoint': {'lat': 45.43687, 'lon': 28.05028}}, {'city': 'Tg.Mures', 'country': 'Romania', 'facility': 'Boehringer Ingelheim Investigational site 20'}, {'city': 'Timișoara', 'country': 'Romania', 'facility': 'Boehringer Ingelheim Investigational site 10', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'city': 'Vaslui', 'country': 'Romania', 'facility': 'Boehringer Ingelheim Investigational site 14', 'geoPoint': {'lat': 46.63333, 'lon': 27.73333}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}