Viewing Study NCT00979420

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Ignite Creation Date: 2025-12-25 @ 4:17 AM
Ignite Modification Date: 2026-02-20 @ 6:25 PM
Study NCT ID: NCT00979420
Status: COMPLETED
Last Update Posted: 2014-06-30
First Post: 2009-09-16
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Non-interventional Observational Study With Viramune (Nevirapine) and Various Drug Combinations in the Antiretroviral Combination Treatment of HIV-infected Patients Who Have Already Been Treated for Approx. 10 Years With Viramune
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '14 to 185 months', 'eventGroups': [{'id': 'EG000', 'title': 'Viramune', 'otherNumAtRisk': 356, 'otherNumAffected': 60, 'seriousNumAtRisk': 356, 'seriousNumAffected': 35}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 25}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cardiac valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pneumonia pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Syphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Spinal cord injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 5}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Premature baby', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Substance abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Caesarean section', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 7}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in log10 Viral Load From Baseline to Last Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune'}, {'id': 'OG001', 'title': 'Pre-treated Patients With Baseline HIV RNA<50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG002', 'title': 'Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.260', 'spread': '-5.61;2.25', 'groupId': 'OG000', 'lowerLimit': '-5.61', 'upperLimit': '2.25'}, {'value': '-0.099', 'spread': '-1.69;0.70', 'groupId': 'OG001', 'lowerLimit': '-1.69', 'upperLimit': '0.70'}, {'value': '-2.082', 'spread': '-5.82;0.40', 'groupId': 'OG002', 'lowerLimit': '-5.82', 'upperLimit': '0.40'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.', 'description': 'Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.', 'unitOfMeasure': 'log10 copies/ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): This patient set includes all patients from Treated Set (TS) who have documented at least one value for the viral load before start of therapy with Viramune.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune'}, {'id': 'OG001', 'title': 'Pre-treated Patients With Baseline HIV RNA<50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG002', 'title': 'Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}], 'classes': [{'title': '<50 copies/ml', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}]}, {'title': '>=50 copies/ml', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: This patient set includes all patients from TS who have documented at least one value for the viral load before start of therapy with Viramune.'}, {'type': 'PRIMARY', 'title': 'Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune'}, {'id': 'OG001', 'title': 'Pre-treated Patients With Baseline HIV RNA<50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG002', 'title': 'Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}], 'classes': [{'categories': [{'measurements': [{'value': '380', 'spread': '-323;1749', 'groupId': 'OG000', 'lowerLimit': '-323', 'upperLimit': '1749'}, {'value': '223.5', 'spread': '-328;1104', 'groupId': 'OG001', 'lowerLimit': '-328', 'upperLimit': '1104'}, {'value': '228', 'spread': '-360;1004', 'groupId': 'OG002', 'lowerLimit': '-360', 'upperLimit': '1004'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.', 'description': 'Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.', 'unitOfMeasure': 'CD4+ cells/mm3', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: This patient set includes all patients from TS who have documented at least one value for the viral load before start of therapy with Viramune.'}, {'type': 'PRIMARY', 'title': 'Change in log10 Viral Load From Baseline to Last Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune'}, {'id': 'OG001', 'title': 'Pre-treated Patients With Baseline HIV RNA<50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG002', 'title': 'Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.284', 'spread': '-5.61;0.00', 'groupId': 'OG000', 'lowerLimit': '-5.61', 'upperLimit': '0.00'}, {'value': '0.000', 'spread': '-0.41;0.70', 'groupId': 'OG001', 'lowerLimit': '-0.41', 'upperLimit': '0.70'}, {'value': '-2.000', 'spread': '-5.824;0.40', 'groupId': 'OG002', 'lowerLimit': '-5.824', 'upperLimit': '0.40'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.', 'description': 'Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.', 'unitOfMeasure': 'log10 copies/ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set (PPS): All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune'}, {'id': 'OG001', 'title': 'Pre-treated Patients With Baseline HIV RNA<50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG002', 'title': 'Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}], 'classes': [{'title': '<50 copies/ml', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': '>=50 copies/ml', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.'}, {'type': 'PRIMARY', 'title': 'Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune'}, {'id': 'OG001', 'title': 'Pre-treated Patients With Baseline HIV RNA<50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG002', 'title': 'Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}], 'classes': [{'categories': [{'measurements': [{'value': '392', 'spread': '-323;1027', 'groupId': 'OG000', 'lowerLimit': '-323', 'upperLimit': '1027'}, {'value': '283', 'spread': '-234;1104', 'groupId': 'OG001', 'lowerLimit': '-234', 'upperLimit': '1104'}, {'value': '250', 'spread': '-266;987', 'groupId': 'OG002', 'lowerLimit': '-266', 'upperLimit': '987'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.', 'description': 'Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.', 'unitOfMeasure': 'CD4+ cells/mm3', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune'}, {'id': 'OG001', 'title': 'Pre-treated Patients With Baseline HIV RNA<50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG002', 'title': 'Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG003', 'title': 'Pre-treated Patients With Baseline HIV RNA Not Documented', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}], 'classes': [{'title': '< Grade 1', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Grade 1', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 185 months', 'description': 'Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events ("DAIDS AE Grading Table") was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of cholesterol.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune'}, {'id': 'OG001', 'title': 'Pre-treated Patients With Baseline HIV RNA<50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG002', 'title': 'Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG003', 'title': 'Pre-treated Patients With Baseline HIV RNA Not Documented', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}], 'classes': [{'title': '< Grade 1', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Grade 1', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 185 months', 'description': 'Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of LDL cholesterol.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune'}, {'id': 'OG001', 'title': 'Pre-treated Patients With Baseline HIV RNA<50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG002', 'title': 'Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG003', 'title': 'Pre-treated Patients With Baseline HIV RNA Not Documented', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}], 'classes': [{'title': '< Grade 1', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}]}, {'title': 'Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 185 months', 'description': 'Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of triglycerides.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune'}, {'id': 'OG001', 'title': 'Pre-treated Patients With Baseline HIV RNA<50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG002', 'title': 'Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG003', 'title': 'Pre-treated Patients With Baseline HIV RNA Not Documented', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}], 'classes': [{'title': '< Grade 1', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'Grade 1', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 185 months', 'description': 'Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. 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The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. 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The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of AST'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune'}, {'id': 'OG001', 'title': 'Pre-treated Patients With Baseline HIV RNA<50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG002', 'title': 'Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG003', 'title': 'Pre-treated Patients With Baseline HIV RNA Not Documented', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}], 'classes': [{'title': '< Grade 1', 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}]}, {'title': 'Grade 1', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 185 months', 'description': 'Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. 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The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of Hemoglobin.'}, {'type': 'SECONDARY', 'title': 'Duration of Intake of Viramune', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune'}, {'id': 'OG001', 'title': 'Pre-treated Patients With Baseline HIV RNA <50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG002', 'title': 'Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG003', 'title': 'Pre-treated Patients With Baseline HIV RNA Not Documented', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}], 'classes': [{'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '185'}, {'value': '124', 'groupId': 'OG001', 'lowerLimit': '43', 'upperLimit': '149'}, {'value': '131', 'groupId': 'OG002', 'lowerLimit': '14', 'upperLimit': '159'}, {'value': '129', 'groupId': 'OG003', 'lowerLimit': '105', 'upperLimit': '161'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'End of treatment, up to 185 months', 'description': 'Duration of intake of Viramune', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'History of Therapy With Antiretroviral Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune'}, {'id': 'OG001', 'title': 'Pre-treated Patients With Baseline HIV RNA <50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG002', 'title': 'Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG003', 'title': 'Pre-treated Patients With Baseline HIV RNA Not Documented', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}], 'classes': [{'title': 'Treatment-naive', 'categories': [{'measurements': [{'value': '178', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Pre-treated', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Participants with a history of therapy with antiretroviral medication.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Course of Absolute CD4+ Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune'}, {'id': 'OG001', 'title': 'Pre-treated Patients With Baseline HIV RNA <50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG002', 'title': 'Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}], 'classes': [{'categories': [{'measurements': [{'value': '734', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '1526'}, {'value': '669', 'groupId': 'OG001', 'lowerLimit': '189', 'upperLimit': '1479'}, {'value': '491', 'groupId': 'OG002', 'lowerLimit': '237', 'upperLimit': '1326'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months', 'description': 'The course of absolute CD4+ cell count is presented as the absolute CD4+ cell count at last visit.', 'unitOfMeasure': 'CD4+ cells/mm3', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Drug Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune'}, {'id': 'OG001', 'title': 'Pre-treated Patients With Baseline HIV RNA <50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG002', 'title': 'Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'OG003', 'title': 'Pre-treated Patients With Baseline HIV RNA Not Documented', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 185 months', 'description': 'Number of participants with drug related Adverse Events (AEs)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment-naive Patients', 'description': 'Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune'}, {'id': 'FG001', 'title': 'Pre-treated Patients With Baseline HIV RNA <50 Copies/ml', 'description': 'HIV RNA denotes Human immunodeficiency virus (HIV) Ribonucleic acid (RNA). Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'FG002', 'title': 'Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'FG003', 'title': 'Pre-treated Patients With Baseline HIV RNA Not Documented', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '178'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '59'}, {'groupId': 'FG003', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other reasons not related to Viramune', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '356', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment-naive Patients', 'description': 'Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune'}, {'id': 'BG001', 'title': 'Pre-treated Patients With Baseline HIV RNA<50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'BG002', 'title': 'Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'BG003', 'title': 'Pre-treated Patients With Baseline HIV RNA Not Documented', 'description': 'Baseline reflects the last available documentation before start of treatment with Viramune'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.85', 'spread': '10.54', 'groupId': 'BG000'}, {'value': '54.21', 'spread': '10.42', 'groupId': 'BG001'}, {'value': '51.02', 'spread': '7.66', 'groupId': 'BG002'}, {'value': '53.69', 'spread': '11.05', 'groupId': 'BG003'}, {'value': '51.91', 'spread': '10.24', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '278', 'groupId': 'BG004'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '77', 'groupId': 'BG004'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set - all patients receiving at least one dose of study medication'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'lastUpdateSubmitDate': '2014-06-27', 'studyFirstSubmitDate': '2009-09-16', 'resultsFirstSubmitDate': '2012-05-30', 'studyFirstSubmitQcDate': '2009-09-17', 'lastUpdatePostDateStruct': {'date': '2014-06-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-10', 'studyFirstPostDateStruct': {'date': '2009-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in log10 Viral Load From Baseline to Last Visit', 'timeFrame': 'Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.', 'description': 'Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.'}, {'measure': 'Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit', 'timeFrame': 'Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.'}, {'measure': 'Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit', 'timeFrame': 'Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.', 'description': 'Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.'}, {'measure': 'Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit', 'timeFrame': 'Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.', 'description': 'Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade', 'timeFrame': 'Up to 185 months', 'description': 'Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events ("DAIDS AE Grading Table") was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.'}, {'measure': 'Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade', 'timeFrame': 'Up to 185 months', 'description': 'Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.'}, {'measure': 'Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade', 'timeFrame': 'Up to 185 months', 'description': 'Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.'}, {'measure': 'Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade', 'timeFrame': 'Up to 185 months', 'description': 'Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.'}, {'measure': 'Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade', 'timeFrame': 'Up to 185 months', 'description': 'Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.'}, {'measure': 'Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade', 'timeFrame': 'Up to 185 months', 'description': 'Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.'}, {'measure': 'Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade', 'timeFrame': 'Up to 185 months', 'description': 'Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.'}, {'measure': 'Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade', 'timeFrame': 'Up to 185 months', 'description': 'Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.'}, {'measure': 'Duration of Intake of Viramune', 'timeFrame': 'End of treatment, up to 185 months', 'description': 'Duration of intake of Viramune'}, {'measure': 'History of Therapy With Antiretroviral Medication', 'timeFrame': 'Baseline', 'description': 'Participants with a history of therapy with antiretroviral medication.'}, {'measure': 'Course of Absolute CD4+ Cell Count', 'timeFrame': 'Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months', 'description': 'The course of absolute CD4+ cell count is presented as the absolute CD4+ cell count at last visit.'}, {'measure': 'Number of Participants With Drug Related Adverse Events', 'timeFrame': 'Up to 185 months', 'description': 'Number of participants with drug related Adverse Events (AEs)'}]}, 'conditionsModule': {'keywords': ['treatment experienced'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The question that prompted this study is the extent to which results from clinical trials can be translated into everyday practice (external validity). An observation period of about 10 years extends far beyond the duration of clinical trials. First and foremost are questions about tolerability and the efficacy of an antiretroviral combination treatment with Viramune and other antiretroviral partners. In particular, adverse events will be recorded and the therapeutic effect will be monitored via the course of viral load and improvement of the immune system, based on the CD4 cell count.', 'detailedDescription': 'Study Design:\n\nobservational'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC (R08-0843)\n\nExclusion criteria The exclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC (R08-0843).'}, 'identificationModule': {'nctId': 'NCT00979420', 'briefTitle': 'Non-interventional Observational Study With Viramune (Nevirapine) and Various Drug Combinations in the Antiretroviral Combination Treatment of HIV-infected Patients Who Have Already Been Treated for Approx. 10 Years With Viramune', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Non-interventional Observational Study With Viramune (Nevirapine) and Various Drug Combinations in the Antiretroviral Combination Treatment of HIV-infected Patients Who Have Already Been Treated for Approx. 10 Years With Viramune', 'orgStudyIdInfo': {'id': '1100.1535'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV treatment'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aachen', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 1', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 10', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 11', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 12', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 13', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 14', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 15', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 2', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 3', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 4', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 5', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 6', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 7', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 8', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 9', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bochum', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 16', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Bonn', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 17', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Bremen', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 18', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'city': 'Dortmund', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 19', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'city': 'Duisburg', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 20', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 21', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 22', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 23', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 24', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 25', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 26', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 27', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 28', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 29', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 30', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 31', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 32', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 33', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 34', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 35', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamburg', 'country': 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