Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT00530920
Status:
COMPLETED
Last Update Posted:
2014-06-06
First Post:
2007-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive 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 Pharmaceuticals', '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': '14 days, from first treatment until last treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 200 mg given once daily', 'otherNumAtRisk': 30, 'otherNumAffected': 17, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily', 'description': 'Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily', 'otherNumAtRisk': 25, 'otherNumAffected': 9, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily', 'otherNumAtRisk': 28, 'otherNumAffected': 15, 'seriousNumAtRisk': 28, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Aspartate aminotransferase increaset', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Viral Load (log10 Copies/mL) Change From Baseline (Last Observation Carried Forward (LOCF))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 200 mg given once daily'}, {'id': 'OG001', 'title': 'Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily', 'description': 'Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily'}, {'id': 'OG002', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.43', 'groupId': 'OG000', 'lowerLimit': '-1.66', 'upperLimit': '-1.24'}, {'value': '-1.55', 'groupId': 'OG001', 'lowerLimit': '-1.70', 'upperLimit': '-1.37'}, {'value': '-1.47', 'groupId': 'OG002', 'lowerLimit': '-1.66', 'upperLimit': '-1.09'}]}]}], 'analyses': [{'pValue': '0.997', 'groupIds': ['OG000'], 'paramType': 'Median Difference (Final Values)', 'paramValue': '-1.43', 'groupDescription': 'NULL HYPOTHESIS (H0): Median viral load reduction from baseline \\>1.2 log10 copies/mL within each group', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1', 'groupIds': ['OG001'], 'paramType': 'Median Difference (Final Values)', 'paramValue': '-1.55', 'groupDescription': 'NULL HYPOTHESIS (H0): Median viral load reduction from baseline \\>1.2 log10 copies/mL within each group', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.998', 'groupIds': ['OG002'], 'paramType': 'Median Difference (Final Values)', 'paramValue': '-1.47', 'groupDescription': 'NULL HYPOTHESIS (H0): Median viral load reduction from baseline \\>1.2 log10 copies/mL within each group', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 0) to Final (Day 14)', 'unitOfMeasure': 'Log10 copies/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment'}, {'type': 'SECONDARY', 'title': 'Apparent Oral Clearance I(Cl/F) of Tipranavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 200 mg given once daily'}, {'id': 'OG001', 'title': 'Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily', 'description': 'Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily'}, {'id': 'OG002', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1.45', 'spread': '26.79', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '26.77', 'groupId': 'OG001'}, {'value': '1.57', 'spread': '35.40', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Final (Day 14)', 'description': 'Tipranavir pharmacokinetics - Clearance (CL) is defined as the dose of a drug divided by the area-under-the-concentration-time curve (AUC), ie. CL = Dose / AUC. For extravascu-lar models the fraction of dose absorbed cannot be estimated, therefore "clear-ance" for these models is actually Cl/F where F is the fraction of the drug dose which is absorbed.', 'unitOfMeasure': 'L/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve(AUC) of Tipranavir 24 h for Once Daily (QD) and AUC 12 h for Twice Daily (BID)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 200 mg given once daily'}, {'id': 'OG001', 'title': 'Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily', 'description': 'Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily'}, {'id': 'OG002', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '571.3', 'spread': '27.3', 'groupId': 'OG000'}, {'value': '289.3', 'spread': '26.8', 'groupId': 'OG001'}, {'value': '538.2', 'spread': '36.4', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Final (Day 13 for QD, Day 14 for BID)', 'description': 'Tipranavir (TPV) pharmacokinetics', 'unitOfMeasure': 'h*uM', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment'}, {'type': 'SECONDARY', 'title': 'Concentration-24 Hour (hr) Post Dose of Tipranavir - (Cp 24 h for QD and 12 hr Post Dose (CP 12h) for BID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 200 mg given once daily'}, {'id': 'OG001', 'title': 'Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily', 'description': 'Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily'}, {'id': 'OG002', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '3.26', 'spread': '92.4', 'groupId': 'OG000'}, {'value': '10.27', 'spread': '49.4', 'groupId': 'OG001'}, {'value': '17.75', 'spread': '71.7', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Final (Day 13 for QD, Day 14 for BID)', 'description': 'TPV pharmacokinetics', 'unitOfMeasure': 'uM', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment'}, {'type': 'SECONDARY', 'title': 'Trough Concentration (Cmin) of Tipranavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 200 mg given once daily'}, {'id': 'OG001', 'title': 'Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily', 'description': 'Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily'}, {'id': 'OG002', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '106.8', 'groupId': 'OG000'}, {'value': '12.73', 'spread': '53.1', 'groupId': 'OG001'}, {'value': '21.26', 'spread': '86.8', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Final (Day 13 for QD, Day 14 for BID)', 'description': 'TPV pharmacokinetics', 'unitOfMeasure': 'uM', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration (Cmax) of Tipranavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 200 mg given once daily'}, {'id': 'OG001', 'title': 'Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily', 'description': 'Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily'}, {'id': 'OG002', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '54.64', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '36.98', 'spread': '19.9', 'groupId': 'OG001'}, {'value': '69.66', 'spread': '26.5', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Final (Day 13 for QD, Day 14 for BID)', 'description': 'TPV pharmacokinetics', 'unitOfMeasure': 'uM', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution (V/F) of Tipranavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 200 mg given once daily'}, {'id': 'OG001', 'title': 'Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily', 'description': 'Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily'}, {'id': 'OG002', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '10.02', 'spread': '14.33', 'groupId': 'OG000'}, {'value': '9.33', 'spread': '9.17', 'groupId': 'OG001'}, {'value': '9.39', 'spread': '12.34', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Final (Day 14)', 'description': 'Tipranavir pharmacokinetics', 'unitOfMeasure': 'L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment'}, {'type': 'SECONDARY', 'title': 'Terminal Half-Life (t1/2) of Tipranavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 200 mg given once daily'}, {'id': 'OG001', 'title': 'Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily', 'description': 'Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily'}, {'id': 'OG002', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '4.79', 'spread': '26.3', 'groupId': 'OG000'}, {'value': '4.51', 'spread': '22.4', 'groupId': 'OG001'}, {'value': '4.14', 'spread': '33.6', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Final (Day 14)', 'description': 'Tipranavir pharmacokinetics', 'unitOfMeasure': 'h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment'}, {'type': 'SECONDARY', 'title': 'Time to Cmax (Tmax) of Tipranavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 200 mg given once daily'}, {'id': 'OG001', 'title': 'Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily', 'description': 'Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily'}, {'id': 'OG002', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '3.07', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '2.34', 'spread': '15.2', 'groupId': 'OG001'}, {'value': '2.38', 'spread': '16.6', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Final (Day 14)', 'description': 'Tipranavir pharmacokinetics', 'unitOfMeasure': 'h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment'}, {'type': 'SECONDARY', 'title': 'AUC 24 of Ritonavir for QD and AUC 12 of Ritonavir for BID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 200 mg given once daily'}, {'id': 'OG001', 'title': 'Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily', 'description': 'Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily'}, {'id': 'OG002', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '5.05', 'spread': '44.0', 'groupId': 'OG000'}, {'value': '2.25', 'spread': '47.0', 'groupId': 'OG001'}, {'value': '1.74', 'spread': '48.9', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Final (Day 13 for QD, Day 14 for BID)', 'description': 'Ritonavir pharmacokinetics', 'unitOfMeasure': 'h*uM', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment'}, {'type': 'SECONDARY', 'title': 'Cp 24 h of Ritonavir for QD and CP 12 h of Ritonavir for BID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 200 mg given once daily'}, {'id': 'OG001', 'title': 'Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily', 'description': 'Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily'}, {'id': 'OG002', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.005', 'spread': '206.2', 'groupId': 'OG000'}, {'value': '0.039', 'spread': '134.0', 'groupId': 'OG001'}, {'value': '0.025', 'spread': '129.9', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Final (Day 13 for QD, Day 14 for BID)', 'description': 'Ritonavir pharmacokinetics', 'unitOfMeasure': 'uM', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment'}, {'type': 'SECONDARY', 'title': 'Apparent Oral Clearance I(Cl/F) of Ritonavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 200 mg given once daily'}, {'id': 'OG001', 'title': 'Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily', 'description': 'Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily'}, {'id': 'OG002', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '39.6', 'spread': '44.0', 'groupId': 'OG000'}, {'value': '44.4', 'spread': '47.0', 'groupId': 'OG001'}, {'value': '57.4', 'spread': '48.9', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Final (Day 13 for QD, Day 14 for BID)', 'description': 'Ritonavir pharmacokinetics', 'unitOfMeasure': 'L/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution (V/F) of Ritonavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 200 mg given once daily'}, {'id': 'OG001', 'title': 'Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily', 'description': 'Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily'}, {'id': 'OG002', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '97.5', 'spread': '26.8', 'groupId': 'OG000'}, {'value': '90.8', 'spread': '24.7', 'groupId': 'OG001'}, {'value': '88.9', 'spread': '28.7', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Final (Day 14)', 'description': 'Ritonavir pharmacokinetics', 'unitOfMeasure': 'L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment'}, {'type': 'SECONDARY', 'title': 'Terminal Half-Life (t1/2) of Ritonavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 200 mg given once daily'}, {'id': 'OG001', 'title': 'Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily', 'description': 'Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily'}, {'id': 'OG002', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1.71', 'spread': '45.5', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '59.5', 'groupId': 'OG001'}, {'value': '1.07', 'spread': '56.1', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Final (Day 14)', 'description': 'Ritonavir pharmacokinetics', 'unitOfMeasure': 'Hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment'}, {'type': 'SECONDARY', 'title': 'Tmax of Ritonavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 200 mg given once daily'}, {'id': 'OG001', 'title': 'Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily', 'description': 'Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily'}, {'id': 'OG002', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2.84', 'spread': '23.9', 'groupId': 'OG000'}, {'value': '2.33', 'spread': '24.9', 'groupId': 'OG001'}, {'value': '2.05', 'spread': '28.8', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Final (Day 14)', 'description': 'Ritonavir pharmacokinetics', 'unitOfMeasure': 'h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment'}, {'type': 'SECONDARY', 'title': 'Cmax of Ritonavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 200 mg given once daily'}, {'id': 'OG001', 'title': 'Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily', 'description': 'Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily'}, {'id': 'OG002', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.632', 'spread': '32.5', 'groupId': 'OG000'}, {'value': '0.346', 'spread': '30.7', 'groupId': 'OG001'}, {'value': '0.291', 'spread': '34.7', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Visits baseline, 5, 7, 9 and 13 or 14', 'description': 'Ritonavir pharmacokinetics', 'unitOfMeasure': 'uM', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment'}, {'type': 'SECONDARY', 'title': 'Clinical Abnormal Findings in Laboratory and Physical Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 200 mg given once daily'}, {'id': 'OG001', 'title': 'Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 200 mg given once daily'}, {'id': 'OG002', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily'}], 'classes': [{'title': 'Alanine aminotransferase (ALT) increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Aspartate aminotransferase (AST) increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening through the end of the study (14 days)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 200 mg given once daily'}, {'id': 'FG001', 'title': 'Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily', 'description': 'Tipranavir 250 mg boosted with ritonavir 100 mg given once daily'}, {'id': 'FG002', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 200 mg given once daily'}, {'id': 'BG001', 'title': 'Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily', 'description': 'Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily'}, {'id': 'BG002', 'title': 'Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily', 'description': 'Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33', 'spread': '7.54', 'groupId': 'BG000'}, {'value': '36.9', 'spread': '8.04', 'groupId': 'BG001'}, {'value': '36.4', 'spread': '8', 'groupId': 'BG002'}, {'value': '35.3', 'spread': '7.94', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'lastUpdateSubmitDate': '2014-05-27', 'studyFirstSubmitDate': '2007-09-17', 'resultsFirstSubmitDate': '2009-05-15', 'studyFirstSubmitQcDate': '2007-09-17', 'lastUpdatePostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-05-15', 'studyFirstPostDateStruct': {'date': '2007-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Viral Load (log10 Copies/mL) Change From Baseline (Last Observation Carried Forward (LOCF))', 'timeFrame': 'Baseline (Day 0) to Final (Day 14)'}], 'secondaryOutcomes': [{'measure': 'Apparent Oral Clearance I(Cl/F) of Tipranavir', 'timeFrame': 'Final (Day 14)', 'description': 'Tipranavir pharmacokinetics - Clearance (CL) is defined as the dose of a drug divided by the area-under-the-concentration-time curve (AUC), ie. CL = Dose / AUC. For extravascu-lar models the fraction of dose absorbed cannot be estimated, therefore "clear-ance" for these models is actually Cl/F where F is the fraction of the drug dose which is absorbed.'}, {'measure': 'Area Under the Curve(AUC) of Tipranavir 24 h for Once Daily (QD) and AUC 12 h for Twice Daily (BID)', 'timeFrame': 'Final (Day 13 for QD, Day 14 for BID)', 'description': 'Tipranavir (TPV) pharmacokinetics'}, {'measure': 'Concentration-24 Hour (hr) Post Dose of Tipranavir - (Cp 24 h for QD and 12 hr Post Dose (CP 12h) for BID', 'timeFrame': 'Final (Day 13 for QD, Day 14 for BID)', 'description': 'TPV pharmacokinetics'}, {'measure': 'Trough Concentration (Cmin) of Tipranavir', 'timeFrame': 'Final (Day 13 for QD, Day 14 for BID)', 'description': 'TPV pharmacokinetics'}, {'measure': 'Maximum Concentration (Cmax) of Tipranavir', 'timeFrame': 'Final (Day 13 for QD, Day 14 for BID)', 'description': 'TPV pharmacokinetics'}, {'measure': 'Volume of Distribution (V/F) of Tipranavir', 'timeFrame': 'Final (Day 14)', 'description': 'Tipranavir pharmacokinetics'}, {'measure': 'Terminal Half-Life (t1/2) of Tipranavir', 'timeFrame': 'Final (Day 14)', 'description': 'Tipranavir pharmacokinetics'}, {'measure': 'Time to Cmax (Tmax) of Tipranavir', 'timeFrame': 'Final (Day 14)', 'description': 'Tipranavir pharmacokinetics'}, {'measure': 'AUC 24 of Ritonavir for QD and AUC 12 of Ritonavir for BID', 'timeFrame': 'Final (Day 13 for QD, Day 14 for BID)', 'description': 'Ritonavir pharmacokinetics'}, {'measure': 'Cp 24 h of Ritonavir for QD and CP 12 h of Ritonavir for BID', 'timeFrame': 'Final (Day 13 for QD, Day 14 for BID)', 'description': 'Ritonavir pharmacokinetics'}, {'measure': 'Apparent Oral Clearance I(Cl/F) of Ritonavir', 'timeFrame': 'Final (Day 13 for QD, Day 14 for BID)', 'description': 'Ritonavir pharmacokinetics'}, {'measure': 'Volume of Distribution (V/F) of Ritonavir', 'timeFrame': 'Final (Day 14)', 'description': 'Ritonavir pharmacokinetics'}, {'measure': 'Terminal Half-Life (t1/2) of Ritonavir', 'timeFrame': 'Final (Day 14)', 'description': 'Ritonavir pharmacokinetics'}, {'measure': 'Tmax of Ritonavir', 'timeFrame': 'Final (Day 14)', 'description': 'Ritonavir pharmacokinetics'}, {'measure': 'Cmax of Ritonavir', 'timeFrame': 'Visits baseline, 5, 7, 9 and 13 or 14', 'description': 'Ritonavir pharmacokinetics'}, {'measure': 'Clinical Abnormal Findings in Laboratory and Physical Examination', 'timeFrame': 'Screening through the end of the study (14 days)'}]}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to identify an optimal dose combination(s) of tipranavir (TPV) and ritonavir (RTV) for antiretroviral treatment naïve HIV-1 infected patients that can be used in pivotal trial by assessing the steady-state pharmacokinetics and short-term efficacy and safety'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent in accordance with GCP and local regulatory requirements prior to trial participation.\n* HIV-1 infected men and non-pregnant women who are treatment naïve, with positive serology (EIA) confirmed by Western blot.\n* Age \\> 18 and \\< 65 years.\n* CD4 \\> 200 cells/mm3\n* Viral load (HIV-1 mRNA viral load) \\> 5,000 copies/mL.\n* Ability to swallow multiple large capsules without difficulty.\n* Acceptable laboratory values that indicate adequate baseline organ function at screening visit.\n* Laboratory values are considered to be acceptable if the severity of any parameter is = \\< Grade 2, based on the DAIDS/ACTG Grading Scale (see Appendix 10.2).\n* Acceptable medical history, physical examination, and 12-lead ECG at screening\n* Willingness to abstain from the following starting 2 weeks prior to administration of any study medication and up until the end of the study:\n\n o Grapefruit or grapefruit juice, Seville oranges, St. John's Wort, and Milk Thistle.\n* Willingness to abstain from alcohol 3 days prior to administration of any study medication up to the end of the study.\n* Willingness to abstain from the following starting 3 days prior to PK sampling:\n\n o Garlic supplements and methylxanthine containing foods or drinks (including coffee, tea, cola, energy drinks, chocolate, etc.).\n* Willingness to abstain from over-the-counter herbal medications for the duration of the study.\n* Willingness to abstain from any over the counter medication 7 days prior to administration of any study medication (including vitamins, minerals, dietary supplements and antacids) during the study until completion of the post study assessments.\n\nExclusion Criteria:\n\n* Female patients of reproductive potential who:\n\n * Have positive serum pregnancy test.\n * Have not been using a barrier method of contraception for at least 3 months prior to participation in the study.\n * Are not willing to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and 60 days after completion/termination of the trial.\n * Are breast-feeding.\n* Suspected or documented seroconversion within last 6 months\n* Participation in another trial with an investigational medicine within 2 months prior to Day 0 of this study.\n* Use of any pharmacological contraceptive (including oral, patch or injectable contraceptives) within 1 month prior to Day 0 and for the duration of the study.\n* Use of hormone replacement therapy within 1 month prior to Day 0 and anytime during the study.\n* History of acute illness within 30 days prior to Day 0.\n* Have evidence of active or acute HBV or HCV.\n* Alcohol or substance abuse within 1 year prior to screening or during the study.\n* Patients with a history of any illness or allergy that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering TPV.\n* Patients who have taken (within 7 days prior to Day 0) any over-the-counter or prescription medication that, in the opinion of the investigator in consultation with the BI clinical monitor, might interfere with absorption, distribution, or metabolism of the study medications.\n* Known hypersensitivity to any ingredients of the test drug.\n* Inability to adhere to the protocol.\n* Genotypic resistance to tipranavir (defined as a TPV mutation score \\> 4)."}, 'identificationModule': {'nctId': 'NCT00530920', 'briefTitle': 'Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Multicenter, Randomized, Open Label, Clinical Trial to Evaluate Three Doses of Tipranavir Boosted With Ritonavir (500 mg/200 mg qd, 250 mg/100 mg Bid and 500 mg/100 mg Bid) by Assessing the Steady-state Pharmacokinetics and Short-term Efficacy and Safety in HIV-1 Positive Treatment naïve Patients', 'orgStudyIdInfo': {'id': '1182.107'}}, 'armsInterventionsModule': {'interventions': [{'name': 'tipranavir', 'type': 'DRUG'}, {'name': 'ritonavir', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': '1182.107.49002 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': '1182.107.49004 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': '1182.107.49003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'city': 'München', 'country': 'Germany', 'facility': '1182.107.49001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Antella (fi)', 'country': 'Italy', 'facility': '1182.107.39001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.72774, 'lon': 11.32233}}, {'city': 'Bari', 'country': 'Italy', 'facility': '1182.107.39009 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Ferrara', 'country': 'Italy', 'facility': '1182.107.39007 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'city': 'Palermo', 'country': 'Italy', 'facility': '1182.107.39011 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': '1182.107.34001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': '1182.107.34002 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': "L'Hospitalet de Llobregat", 'country': 'Spain', 'facility': '1182.107.34003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'city': 'Madrid', 'country': 'Spain', 'facility': '1182.107.34004 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Boehringer Ingelheim, Study Chair', 'oldOrganization': 'Boehringer Ingelheim'}}}}