Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT01153269
Status:
COMPLETED
Last Update Posted:
2011-12-19
First Post:
2010-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Long-term Effectiveness and Safety in Hepatitis-co-infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061466', 'term': 'Lopinavir'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'C558899', 'term': 'lopinavir-ritonavir drug combination'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-633-9110', 'title': 'Global Medical Services', 'organization': 'Abbott'}, 'certainAgreement': {'otherDetails': 'Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Investigators were instructed to report adverse events throughout the study (up to 3 years).', 'eventGroups': [{'id': 'EG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.', 'otherNumAtRisk': 33, 'otherNumAffected': 1, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'antiviral drug level above therapeutic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Raw (uncoded) terms'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection: AST', 'description': 'Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}, {'id': 'OG001', 'title': 'HIV-infected Participants With Hepatitis Co-infection: ALT', 'description': 'Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': '63', 'groupId': 'OG000'}, {'value': '69', 'spread': '88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented.", 'unitOfMeasure': 'U/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with aspartate aminotransferase and alanine aminotransferase results at Baseline.'}, {'type': 'PRIMARY', 'title': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection: AST', 'description': 'Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}, {'id': 'OG001', 'title': 'HIV-infected Participants With Hepatitis Co-infection: ALT', 'description': 'Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'spread': '96', 'groupId': 'OG000'}, {'value': '85', 'spread': '86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented.", 'unitOfMeasure': 'U/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with aspartate aminotransferase and alanine aminotransferase results at Week 4.'}, {'type': 'PRIMARY', 'title': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection: AST', 'description': 'Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}, {'id': 'OG001', 'title': 'HIV-infected Participants With Hepatitis Co-infection: ALT', 'description': 'Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'spread': '50', 'groupId': 'OG000'}, {'value': '85', 'spread': '79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented.", 'unitOfMeasure': 'U/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with aspartate aminotransferase and alanine aminotransferase results at Week 12.'}, {'type': 'PRIMARY', 'title': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection: AST', 'description': 'Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}, {'id': 'OG001', 'title': 'HIV-infected Participants With Hepatitis Co-infection: ALT', 'description': 'Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'spread': '94', 'groupId': 'OG000'}, {'value': '97', 'spread': '134', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented.", 'unitOfMeasure': 'U/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with aspartate aminotransferase and alanine aminotransferase results at Week 24.'}, {'type': 'PRIMARY', 'title': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection: AST', 'description': 'Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}, {'id': 'OG001', 'title': 'HIV-infected Participants With Hepatitis Co-infection: ALT', 'description': 'Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'spread': '33', 'groupId': 'OG000'}, {'value': '75', 'spread': '87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 36', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented.", 'unitOfMeasure': 'U/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with aspartate aminotransferase and alanine aminotransferase results at Week 36.'}, {'type': 'PRIMARY', 'title': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection: AST', 'description': 'Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}, {'id': 'OG001', 'title': 'HIV-infected Participants With Hepatitis Co-infection: ALT', 'description': 'Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '41', 'groupId': 'OG000'}, {'value': '79', 'spread': '92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 48', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented.", 'unitOfMeasure': 'U/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with aspartate aminotransferase and alanine aminotransferase results at Week 48.'}, {'type': 'PRIMARY', 'title': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection: AST', 'description': 'Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}, {'id': 'OG001', 'title': 'HIV-infected Participants With Hepatitis Co-infection: ALT', 'description': 'Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'spread': '38', 'groupId': 'OG000'}, {'value': '59', 'spread': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 60', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented.", 'unitOfMeasure': 'U/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with aspartate aminotransferase and alanine aminotransferase results at Week 60.'}, {'type': 'PRIMARY', 'title': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection: AST', 'description': 'Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}, {'id': 'OG001', 'title': 'HIV-infected Participants With Hepatitis Co-infection: ALT', 'description': 'Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'spread': '36', 'groupId': 'OG000'}, {'value': '50', 'spread': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 72', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented.", 'unitOfMeasure': 'U/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with aspartate aminotransferase and alanine aminotransferase results at Week 72.'}, {'type': 'PRIMARY', 'title': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection: AST', 'description': 'Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}, {'id': 'OG001', 'title': 'HIV-infected Participants With Hepatitis Co-infection: ALT', 'description': 'Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'spread': '33', 'groupId': 'OG000'}, {'value': '49', 'spread': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 84', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented.", 'unitOfMeasure': 'U/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with aspartate aminotransferase and alanine aminotransferase results at Week 84.'}, {'type': 'PRIMARY', 'title': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection: AST', 'description': 'Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}, {'id': 'OG001', 'title': 'HIV-infected Participants With Hepatitis Co-infection: ALT', 'description': 'Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'spread': '44', 'groupId': 'OG000'}, {'value': '63', 'spread': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 96', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented.", 'unitOfMeasure': 'U/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with aspartate aminotransferase and alanine aminotransferase results at Week 96.'}, {'type': 'PRIMARY', 'title': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection: AST', 'description': 'Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}, {'id': 'OG001', 'title': 'HIV-infected Participants With Hepatitis Co-infection: ALT', 'description': 'Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'spread': '19', 'groupId': 'OG000'}, {'value': '43', 'spread': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 108', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented.", 'unitOfMeasure': 'U/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with aspartate aminotransferase and alanine aminotransferase results at Week 108.'}, {'type': 'PRIMARY', 'title': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection: AST', 'description': 'Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}, {'id': 'OG001', 'title': 'HIV-infected Participants With Hepatitis Co-infection: ALT', 'description': 'Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'spread': '30', 'groupId': 'OG000'}, {'value': '65', 'spread': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 120', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented.", 'unitOfMeasure': 'U/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with aspartate aminotransferase and alanine aminotransferase results at Week 120.'}, {'type': 'PRIMARY', 'title': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection: AST', 'description': 'Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}, {'id': 'OG001', 'title': 'HIV-infected Participants With Hepatitis Co-infection: ALT', 'description': 'Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'spread': '24', 'groupId': 'OG000'}, {'value': '51', 'spread': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 132', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented.", 'unitOfMeasure': 'U/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with aspartate aminotransferase and alanine aminotransferase results at Week 132.'}, {'type': 'PRIMARY', 'title': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection: AST', 'description': 'Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}, {'id': 'OG001', 'title': 'HIV-infected Participants With Hepatitis Co-infection: ALT', 'description': 'Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '28', 'groupId': 'OG000'}, {'value': '53', 'spread': '36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 144', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented.", 'unitOfMeasure': 'U/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with aspartate aminotransferase and alanine aminotransferase results at Week 144.'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented.", 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with HIV-1 RNA results at Baseline.'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented.", 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with HIV-1 RNA results at Week 4.'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented.", 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with HIV-1 RNA results at Week 12.'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '0.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented.", 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with HIV-1 RNA results at Week 24.'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 36', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented.", 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with HIV-1 RNA results at Week 36.'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 48', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented.", 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with HIV-1 RNA results at Week 48.'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '0.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 60', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented.", 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with HIV-1 RNA results at Week 60.'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 72', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented.", 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with HIV-1 RNA results at Week 72.'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 84', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented.", 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with HIV-1 RNA results at Week 84.'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 96', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented.", 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with HIV-1 RNA results at Week 96.'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 108', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented.", 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with HIV-1 RNA results at Week 108.'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 120', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented.", 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with HIV-1 RNA results at Week 120.'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 132', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented.", 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with HIV-1 RNA results at Week 132.'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 144', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented.", 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with HIV-1 RNA results at Week 144.'}, {'type': 'PRIMARY', 'title': 'CD4 Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '288', 'spread': '192', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Baseline are presented.", 'unitOfMeasure': 'CD4+ cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with CD4+ cell count measurements at Baseline are included.'}, {'type': 'PRIMARY', 'title': 'CD4 Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C'}], 'classes': [{'categories': [{'measurements': [{'value': '350', 'spread': '165', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 4 are presented.", 'unitOfMeasure': 'CD4+ cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with CD4+ cell count measurements at Week 4 are included.'}, {'type': 'PRIMARY', 'title': 'CD4 Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '378', 'spread': '204', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 12 are presented.", 'unitOfMeasure': 'CD4+ cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with CD4+ cell count measurements at Week 12 are included.'}, {'type': 'PRIMARY', 'title': 'CD4 Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '383', 'spread': '211', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 24 are presented.", 'unitOfMeasure': 'CD4+ cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with CD4+ cell count measurements at Week 24 are included.'}, {'type': 'PRIMARY', 'title': 'CD4 Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '408', 'spread': '187', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 36', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 36 are presented.", 'unitOfMeasure': 'CD4+ cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with CD4+ cell count measurements at Week 36 are included.'}, {'type': 'PRIMARY', 'title': 'CD4 Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '402', 'spread': '239', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 48', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 48 are presented.", 'unitOfMeasure': 'CD4+ cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with CD4+ cell count measurements at Week 48 are included.'}, {'type': 'PRIMARY', 'title': 'CD4 Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '424', 'spread': '193', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 60', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 60 are presented.", 'unitOfMeasure': 'CD4+ cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with CD4+ cell count measurements at Baseline are included.'}, {'type': 'PRIMARY', 'title': 'CD4 Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '431', 'spread': '235', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 72', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 72 are presented.", 'unitOfMeasure': 'CD4+ cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with CD4+ cell count measurements at Week 72 are included.'}, {'type': 'PRIMARY', 'title': 'CD4 Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '405', 'spread': '170', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 84', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 84 are presented.", 'unitOfMeasure': 'CD4+ cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with CD4+ cell count measurements at Week 84 are included.'}, {'type': 'PRIMARY', 'title': 'CD4 Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '503', 'spread': '237', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 96', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 96 are presented.", 'unitOfMeasure': 'CD4+ cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with CD4+ cell count measurements at Week 96 are included.'}, {'type': 'PRIMARY', 'title': 'CD4 Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '581', 'spread': '303', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 108', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 108 are presented.", 'unitOfMeasure': 'CD4+ cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with CD4+ cell count measurements at Week 108 are included.'}, {'type': 'PRIMARY', 'title': 'CD4 Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '565', 'spread': '256', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 120', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 120 are presented.", 'unitOfMeasure': 'CD4+ cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with CD4+ cell count measurements at Week 120 are included.'}, {'type': 'PRIMARY', 'title': 'CD4 Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '502', 'spread': '259', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 132', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 132 are presented.", 'unitOfMeasure': 'CD4+ cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with CD4+ cell count measurements at Week 132 are included.'}, {'type': 'PRIMARY', 'title': 'CD4 Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C'}], 'classes': [{'categories': [{'measurements': [{'value': '525', 'spread': '226', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 144', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 144 are presented.", 'unitOfMeasure': 'CD4+ cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with CD4+ cell count measurements at Week 144 are included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'Participants Analyzed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Antiretroviral therapy break', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'HIV-infected Participants With Hepatitis Co-infection', 'description': 'HIV-infected participants with co-infections of hepatitis B or hepatitis C.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.4', 'spread': '7.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hepatitis Co-infection', 'classes': [{'title': 'Chronic hepatitis B', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Chronic hepatitis C', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The number of participants with hepatitis B or hepatitis C co-infection.', 'unitOfMeasure': 'participants'}, {'title': 'Duration of HIV infection', 'classes': [{'categories': [{'measurements': [{'value': '9.7', 'spread': '7.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'How long participants had been diagnosed with HIV infection at Baseline. Based on 32 participants.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-16', 'studyFirstSubmitDate': '2010-02-26', 'resultsFirstSubmitDate': '2011-11-16', 'studyFirstSubmitQcDate': '2010-06-28', 'lastUpdatePostDateStruct': {'date': '2011-12-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-16', 'studyFirstPostDateStruct': {'date': '2010-06-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'timeFrame': 'Baseline', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented."}, {'measure': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'timeFrame': 'Week 4', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented."}, {'measure': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'timeFrame': 'Week 12', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented."}, {'measure': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'timeFrame': 'Week 24', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented."}, {'measure': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'timeFrame': 'Week 36', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented."}, {'measure': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'timeFrame': 'Week 48', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented."}, {'measure': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'timeFrame': 'Week 60', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented."}, {'measure': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'timeFrame': 'Week 72', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented."}, {'measure': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'timeFrame': 'Week 84', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented."}, {'measure': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'timeFrame': 'Week 96', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented."}, {'measure': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'timeFrame': 'Week 108', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented."}, {'measure': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'timeFrame': 'Week 120', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented."}, {'measure': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'timeFrame': 'Week 132', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented."}, {'measure': 'Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters', 'timeFrame': 'Week 144', 'description': "The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented."}, {'measure': 'Viral Load', 'timeFrame': 'Baseline', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented."}, {'measure': 'Viral Load', 'timeFrame': 'Week 4', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented."}, {'measure': 'Viral Load', 'timeFrame': 'Week 12', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented."}, {'measure': 'Viral Load', 'timeFrame': 'Week 24', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented."}, {'measure': 'Viral Load', 'timeFrame': 'Week 36', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented."}, {'measure': 'Viral Load', 'timeFrame': 'Week 48', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented."}, {'measure': 'Viral Load', 'timeFrame': 'Week 60', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented."}, {'measure': 'Viral Load', 'timeFrame': 'Week 72', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented."}, {'measure': 'Viral Load', 'timeFrame': 'Week 84', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented."}, {'measure': 'Viral Load', 'timeFrame': 'Week 96', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented."}, {'measure': 'Viral Load', 'timeFrame': 'Week 108', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented."}, {'measure': 'Viral Load', 'timeFrame': 'Week 120', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented."}, {'measure': 'Viral Load', 'timeFrame': 'Week 132', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented."}, {'measure': 'Viral Load', 'timeFrame': 'Week 144', 'description': "The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented."}, {'measure': 'CD4 Cell Count', 'timeFrame': 'Baseline', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Baseline are presented."}, {'measure': 'CD4 Cell Count', 'timeFrame': 'Week 4', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 4 are presented."}, {'measure': 'CD4 Cell Count', 'timeFrame': 'Week 12', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 12 are presented."}, {'measure': 'CD4 Cell Count', 'timeFrame': 'Week 24', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 24 are presented."}, {'measure': 'CD4 Cell Count', 'timeFrame': 'Week 36', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 36 are presented."}, {'measure': 'CD4 Cell Count', 'timeFrame': 'Week 48', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 48 are presented."}, {'measure': 'CD4 Cell Count', 'timeFrame': 'Week 60', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 60 are presented."}, {'measure': 'CD4 Cell Count', 'timeFrame': 'Week 72', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 72 are presented."}, {'measure': 'CD4 Cell Count', 'timeFrame': 'Week 84', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 84 are presented."}, {'measure': 'CD4 Cell Count', 'timeFrame': 'Week 96', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 96 are presented."}, {'measure': 'CD4 Cell Count', 'timeFrame': 'Week 108', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 108 are presented."}, {'measure': 'CD4 Cell Count', 'timeFrame': 'Week 120', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 120 are presented."}, {'measure': 'CD4 Cell Count', 'timeFrame': 'Week 132', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 132 are presented."}, {'measure': 'CD4 Cell Count', 'timeFrame': 'Week 144', 'description': "The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 144 are presented."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Human Immunodeficiency Virus', 'Co-infection with Hepatitis B or Hepatitis C', 'Tolerability', 'Effectiveness'], 'conditions': ['Human Immunodeficiency Virus-Infection']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to observe the tolerability and effectiveness of Kaletra in Human Immunodeficiency Virus/Hepatitis-B Virus and Human Immunodeficiency Virus/Hepatitis-C Virus co-infected patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample, Human Immunodeficiency Virus-infected patients with Hepatitis B or C co-infections', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients infected by HIV-1 and HBV or HCV\n* Age ≥18 years\n* Patients who were initiated on a LPV/r containing antiretroviral (ARV) regimen\n\nExclusion Criteria:\n\n\\- Contraindications as described in SmPC (summary of product characteristics) at the time of prescription'}, 'identificationModule': {'nctId': 'NCT01153269', 'briefTitle': 'Long-term Effectiveness and Safety in Hepatitis-co-infected Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'Long-term Effectiveness and Safety in Hepatitis-co-infected Patients', 'orgStudyIdInfo': {'id': 'KAL 1 HO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV-infected patients with hepatitis co-infection', 'description': 'HIV-infected patients with co-infections of Hepatitis B or Hepatitis C', 'interventionNames': ['Drug: Lopinavir/Ritonavir (Kaletra)']}], 'interventions': [{'name': 'Lopinavir/Ritonavir (Kaletra)', 'type': 'DRUG', 'description': '3 capsules 2xdaily or 2 tablets 2xdaily Kaletra', 'armGroupLabels': ['HIV-infected patients with hepatitis co-infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10243', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 27575', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10961', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 27592', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44137', 'city': 'Dortmund', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 27588', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'zip': '60311', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 27583', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '60596', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 27587', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '20099', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 27607', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '47800', 'city': 'Krefeld', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 5355', 'geoPoint': {'lat': 51.33645, 'lon': 6.55381}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 27604', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'overallOfficials': [{'name': 'Stefan Simianer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Germany, Medical Department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}