Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2026-01-20 @ 3:38 PM
Study NCT ID:
NCT00531206
Status:
COMPLETED
Last Update Posted:
2014-04-07
First Post:
2007-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Observational Non-interventional Study (Anwendungsbeobachtung) With Aptivus® (Tipranavir) in HIV-infected Patients.
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': {'timeFrame': '52 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Aptivus® in Combination With Low-dose Norvir®', 'description': 'Aptivus® in combination with low-dose Norvir® and optimised backbone therapy', 'otherNumAtRisk': 65, 'otherNumAffected': 4, 'seriousNumAtRisk': 65, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aptivus® in Combination With Low-dose Norvir®', 'description': 'Aptivus® in combination with low-dose Norvir® and optimised backbone therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'description': 'The 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[{'title': 'Low (< 18)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Normal (18 - 30)', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': 'High (> 30)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), all patients entered and treated'}, {'type': 'SECONDARY', 'title': 'Total Cholesterol Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aptivus® in Combination With Low-dose Norvir®', 'description': 'Aptivus® in combination with low-dose Norvir® and optimised backbone therapy'}], 'classes': [{'title': 'Month 1 (n=42)', 'categories': [{'measurements': 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[{'measurements': [{'value': '125.0', 'groupId': 'OG000', 'lowerLimit': '110.0', 'upperLimit': '147.0'}]}]}, {'title': 'Month 9 (n=26)', 'categories': [{'measurements': [{'value': '117.5', 'groupId': 'OG000', 'lowerLimit': '98.0', 'upperLimit': '132.0'}]}]}, {'title': 'Month 12 (n=23)', 'categories': [{'measurements': [{'value': '122.0', 'groupId': 'OG000', 'lowerLimit': '102.0', 'upperLimit': '138.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 weeks', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), all patients entered and treated'}, {'type': 'SECONDARY', 'title': 'Triglycerides Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aptivus® in Combination With Low-dose Norvir®', 'description': 'Aptivus® in combination with low-dose Norvir® and optimised backbone therapy'}], 'classes': [{'title': 'Month 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'title': 'Alanine Aminotransferase (ALT) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aptivus® in Combination With Low-dose Norvir®', 'description': 'Aptivus® in combination with low-dose Norvir® and optimised backbone therapy'}], 'classes': [{'title': 'Month 1 (n=52)', 'categories': [{'measurements': [{'value': '33.0', 'groupId': 'OG000', 'lowerLimit': '25.7', 'upperLimit': '48.5'}]}]}, {'title': 'Month 3 (n=49)', 'categories': [{'measurements': [{'value': '31.0', 'groupId': 'OG000', 'lowerLimit': '24.0', 'upperLimit': '50.0'}]}]}, {'title': 'Month 6 (n=55)', 'categories': [{'measurements': [{'value': '37.0', 'groupId': 'OG000', 'lowerLimit': '27.0', 'upperLimit': '51.0'}]}]}, {'title': 'Month 9 (n=41)', 'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000', 'lowerLimit': '28.0', 'upperLimit': '53.0'}]}]}, {'title': 'Month 12 (n=42)', 'categories': [{'measurements': [{'value': 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'Month 6 (n=57)', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '25.0', 'upperLimit': '62.0'}]}]}, {'title': 'Month 9 (n=44)', 'categories': [{'measurements': [{'value': '44.0', 'groupId': 'OG000', 'lowerLimit': '27.0', 'upperLimit': '62.0'}]}]}, {'title': 'Month 12 (n=42)', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000', 'lowerLimit': '29.0', 'upperLimit': '53.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 weeks', 'unitOfMeasure': 'international units/liter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), all patients entered and treated'}, {'type': 'SECONDARY', 'title': 'Gamma-glutamyl Transpeptidase (GGT) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aptivus® in Combination With Low-dose Norvir®', 'description': 'Aptivus® in combination with low-dose Norvir® and optimised backbone therapy'}], 'classes': [{'title': 'Month 1 (n=54)', 'categories': [{'measurements': [{'value': '72.0', 'groupId': 'OG000', 'lowerLimit': '41.0', 'upperLimit': '121.0'}]}]}, {'title': 'Month 3 (n=49)', 'categories': [{'measurements': [{'value': '72.0', 'groupId': 'OG000', 'lowerLimit': '50.0', 'upperLimit': '164.0'}]}]}, {'title': 'Month 6 (n=57)', 'categories': [{'measurements': [{'value': '72.0', 'groupId': 'OG000', 'lowerLimit': '56.0', 'upperLimit': '154.0'}]}]}, {'title': 'Month 9 (n=44)', 'categories': [{'measurements': [{'value': '76.0', 'groupId': 'OG000', 'lowerLimit': '48.0', 'upperLimit': '128.0'}]}]}, {'title': 'Month 12 (n=43)', 'categories': [{'measurements': [{'value': '68.0', 'groupId': 'OG000', 'lowerLimit': '50.0', 'upperLimit': '104.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 weeks', 'unitOfMeasure': 'international units/liter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), all patients entered and treated'}, {'type': 'SECONDARY', 'title': 'Creatinine Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aptivus® in Combination With Low-dose Norvir®', 'description': 'Aptivus® in combination with low-dose Norvir® and optimised backbone therapy'}], 'classes': [{'title': 'Month 1 (n=43)', 'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.80', 'upperLimit': '1.00'}]}]}, {'title': 'Month 3 (n=46)', 'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.80', 'upperLimit': '1.01'}]}]}, {'title': 'Month 6 (n=49)', 'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.80', 'upperLimit': '1.00'}]}]}, {'title': 'Month 9 (n=35)', 'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.80', 'upperLimit': '1.07'}]}]}, {'title': 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optimised backbone therapy'}], 'classes': [{'title': 'Month 1 (n=33)', 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000', 'lowerLimit': '76.0', 'upperLimit': '111.0'}]}]}, {'title': 'Month 3 (n=38)', 'categories': [{'measurements': [{'value': '92.5', 'groupId': 'OG000', 'lowerLimit': '76.0', 'upperLimit': '103.5'}]}]}, {'title': 'Month 6 (n=26)', 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '80.0', 'upperLimit': '114.0'}]}]}, {'title': 'Month 9 (n=24)', 'categories': [{'measurements': [{'value': '86.5', 'groupId': 'OG000', 'lowerLimit': '79.0', 'upperLimit': '118.0'}]}]}, {'title': 'Month 12 (n=43)', 'categories': [{'measurements': [{'value': '92.5', 'groupId': 'OG000', 'lowerLimit': '76.2', 'upperLimit': '108.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 weeks', 'unitOfMeasure': 'international units/liter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), all patients entered and treated'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aptivus® in Combination With Low-dose Norvir®', 'description': 'Aptivus® in combination with low-dose Norvir® and optimised backbone therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Adverse Event related', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'including non-related adverse events', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Aptivus® in Combination With Low-dose Norvir®', 'description': 'Aptivus® in combination with low-dose Norvir® and optimised backbone therapy'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.9', 'spread': '8.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '59', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'lastUpdateSubmitDate': '2014-02-24', 'studyFirstSubmitDate': '2007-09-17', 'resultsFirstSubmitDate': '2010-01-28', 'studyFirstSubmitQcDate': '2007-09-17', 'lastUpdatePostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-04-21', 'studyFirstPostDateStruct': {'date': '2007-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '52 weeks', 'description': 'The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.'}], 'secondaryOutcomes': [{'measure': 'Change in Viral Load', 'timeFrame': 'Baseline and 52 weeks', 'description': 'Log10 change from baseline in viral load over time'}, {'measure': 'CD4+ Cell Count', 'timeFrame': 'Baseline and 52 weeks', 'description': 'Change from baseline in CD4+ count over time'}, {'measure': 'Subjective Well-being', 'timeFrame': '52 weeks', 'description': "Investigator's opinion of patient's general condition (quality of life)"}, {'measure': 'Serious Adverse Events', 'timeFrame': '52 weeks', 'description': 'The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.'}, {'measure': 'Deaths', 'timeFrame': '52 weeks', 'description': 'The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.'}, {'measure': 'Discontinuations Due to an Adverse Event', 'timeFrame': '52 weeks', 'description': 'The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.'}, {'measure': "Adverse Events Related to Therapy With Tipranavir/Ritonavir Based on Investigator's Opinion", 'timeFrame': '52 weeks', 'description': 'The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.'}, {'measure': 'Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir', 'timeFrame': '52 weeks'}, {'measure': 'Use of Lipid Lowering Agents During the Study', 'timeFrame': '52 weeks'}, {'measure': 'Body Mass Index Class (Kilograms/Square Meter)', 'timeFrame': '52 weeks'}, {'measure': 'Total Cholesterol Over Time', 'timeFrame': '52 weeks'}, {'measure': 'High Density Lipoprotein (HDL) Cholesterol Over Time', 'timeFrame': '52 weeks'}, {'measure': 'Low Density Lipoprotein (HDL) Cholesterol Over Time', 'timeFrame': '52 weeks'}, {'measure': 'Triglycerides Over Time', 'timeFrame': '52 weeks'}, {'measure': 'Alanine Aminotransferase (ALT) Over Time', 'timeFrame': '52 weeks'}, {'measure': 'Aspartate Aminotransferase (ALT) Over Time', 'timeFrame': '52 weeks'}, {'measure': 'Gamma-glutamyl Transpeptidase (GGT) Over Time', 'timeFrame': '52 weeks'}, {'measure': 'Creatinine Over Time', 'timeFrame': '52 weeks'}, {'measure': 'Total Bilirubin Over Time', 'timeFrame': '52 weeks'}, {'measure': 'Alkaline Phosphatase Over Time', 'timeFrame': '52 weeks'}]}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Aptivus (tipranavir) in combination with low-dose Norvir (ritonavir) will durably suppress viral load and may achieve suppression of viral load below the limit of detection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nHighly pre-treated male and female adult patients with virus resistant to multiple protease inhibitors. Aptivus (tipranavir), co-administered with low dose Norvir (ritonavir), is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adult patients with virus resistant to multiple protease inhibitors.\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* pregnant female patients\n* Hypersensitivity to the active substance or to any of the excipients.\n* Patients with moderate or severe (Child-Pugh B or C) hepatic impairment.\n* Rifampicin should not be used with Aptivus (tipranavir) because co-administration may cause large decreases in tipranavir concentrations which may in turn significantly decrease the tipranavir therapeutic effect.\n* Herbal preparations containing St John's wort must not be used while taking Aptivus (tipranavir) due to the risk of decreased plasma concentrations and reduced clinical effects of tipranavir.\n* Co-administration of Aptivus (tipranavir) with low dose Norvir (ritonavir), with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. These active substances include antiarrhythmics (amiodarone, bepridil, quinidine), antihistamines (astemizole, terfenadine), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (cisapride), neuroleptics (pimozide, sertindole), sedatives/hypnotics (triazolam) and HMG-CoA reductase inhibitors (simvastatin and lovastatin). In addition, co-administration of Aptivus (tipranavir) with low dose Norvir (ritonavir), with drugs that are highly dependent on CYP2D6 for clearance, such as the antiarrhythmics flecainide and propafenone, is contraindicated."}, 'identificationModule': {'nctId': 'NCT00531206', 'briefTitle': 'Observational Non-interventional Study (Anwendungsbeobachtung) With Aptivus® (Tipranavir) in HIV-infected Patients.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Observational Non-interventional Study About Antiretroviral Combination Treatment With Aptivus in Combination With Low-dose Ritonavir in HIV Type 1 Infected Patients', 'orgStudyIdInfo': {'id': '1182.112'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All participants', 'interventionNames': ['Drug: Tipranavir', 'Drug: Ritonavir']}], 'interventions': [{'name': 'Tipranavir', 'type': 'DRUG', 'armGroupLabels': ['All participants']}, {'name': 'Ritonavir', 'type': 'DRUG', 'description': 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