Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-01-27 @ 10:10 AM
Study NCT ID:
NCT00543803
Status:
COMPLETED
Last Update Posted:
2014-05-20
First Post:
2007-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Observational Non-interventional Study With Viramune® in Combination With Truvada® in HIV-infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, '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': '36 months', 'eventGroups': [{'id': 'EG000', 'title': 'Patients Treated With Viramune in Combination With Truvada', 'description': 'Viramune one tablet 200 mg OD for two weeks, then 200 mg BID, Truvada one tablet QD', 'otherNumAtRisk': 334, 'otherNumAffected': 19, 'seriousNumAtRisk': 334, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anogenital dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rectal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Disease recurrence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hepatitis toxic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anogenital warts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pilonidal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Face injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oligodendroglioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cerebellar ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nervous system disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neuromyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nystagmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Post herpetic neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Drug abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Debridement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 334, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Treated With Viramune in Combination With Truvada', 'description': 'Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '7.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'The change in alanine aminotransferase (ALT) from baseline to the last value in treatment', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS- All patients were considered for the full analysis set.'}, {'type': 'PRIMARY', 'title': 'Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Treated With Viramune in Combination With Truvada', 'description': 'Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '15.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'The change in asparate aminotransferase (AST) from baseline to the last value in treatment', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS- All patients were considered for the full analysis set.'}, {'type': 'PRIMARY', 'title': 'Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Treated With Viramune in Combination With Truvada', 'description': 'Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd'}], 'classes': [{'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '59.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'The change in Gamma-glutamyl transferase (Gamma-GT) from baseline to the last value in treatment', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS- All patients were considered for the full analysis set.'}, {'type': 'PRIMARY', 'title': 'Summary of Change From Baseline in Creatinine to Last Value on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Treated With Viramune in Combination With Truvada', 'description': 'Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'The change in Creatinine from baseline to the last value in treatment', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS- All patients were considered for the full analysis set.'}, {'type': 'PRIMARY', 'title': 'Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Treated With Viramune in Combination With Truvada', 'description': 'Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd'}], 'classes': [{'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '-12.0', 'upperLimit': '40.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'The change in total cholesterol from baseline to the last value in treatment', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS- All patients were considered for the full analysis set.'}, {'type': 'PRIMARY', 'title': 'Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Treated With Viramune in Combination With Truvada', 'description': 'Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '15.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'The change in High-density lipoprotein (HDL) cholesterol from baseline to the last value in treatment', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS- All patients were considered for the full analysis set.'}, {'type': 'PRIMARY', 'title': 'Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Treated With Viramune in Combination With Truvada', 'description': 'Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '-15.0', 'upperLimit': '27.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'The change in Low-density lipoprotein (LDL) cholesterol from baseline to the last value in treatment', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS- All patients were considered for the full analysis set.'}, {'type': 'PRIMARY', 'title': 'Summary of Change From Baseline in Triglycerides to Last Value on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Treated With Viramune in Combination With Truvada', 'description': 'Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.0', 'groupId': 'OG000', 'lowerLimit': '-54.0', 'upperLimit': '29.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'The change in triglycerides from baseline to the last value in treatment', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS- All patients were considered for the full analysis set.'}, {'type': 'PRIMARY', 'title': 'Summary of Change From Baseline in Glucose to Last Value on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Treated With Viramune in Combination With Truvada', 'description': 'Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-8.0', 'upperLimit': '8.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'The change in Glucose from baseline to the last value in treatment', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS- All patients were considered for the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Treated With Viramune in Combination With Truvada', 'description': 'Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.3', 'groupId': 'OG000', 'lowerLimit': '-4.53', 'upperLimit': '0.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'For calculation of this measure switch patients are included in the total which had no viral load decrease.', 'unitOfMeasure': '(log10 copies) / ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS- All patients were considered for the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Summary of Change From Baseline in CD4+ Count to Last Value on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Treated With Viramune in Combination With Truvada', 'description': 'Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd'}], 'classes': [{'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000', 'lowerLimit': '30.5', 'upperLimit': '276.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'unitOfMeasure': '(cells) / mm^3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS- All patients were considered for the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Treated With Viramune in Combination With Truvada', 'description': 'Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'Total number of patients with investigator defined non-serious drug-related AEs was reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS- All patients were considered for the full analysis set.'}, {'type': 'SECONDARY', 'title': "Investigator's Global Clinical Assessment of Patient General Health Status", 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '334', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evaluation Assessment at Baseline', 'description': 'Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at baseline)'}, {'id': 'OG001', 'title': 'Last Evaluation Assessment on Treatment', 'description': 'Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at last evaluation on treatment within 36 months)'}], 'classes': [{'title': 'Good', 'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Bad', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'Investigators opinion of patients general health condition at baseline versus last evaluation on treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS- All patients were considered for the full analysis set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients Treated With Viramune in Combination With Truvada', 'description': 'Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '334'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '192'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '86'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients Treated With Viramune in Combination With Truvada', 'description': 'Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.8', 'spread': '9.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '276', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'FAS - All patients were considered for the full analysis set.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 334}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'lastUpdateSubmitDate': '2014-05-13', 'studyFirstSubmitDate': '2007-10-08', 'resultsFirstSubmitDate': '2010-12-17', 'studyFirstSubmitQcDate': '2007-10-12', 'lastUpdatePostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-12-17', 'studyFirstPostDateStruct': {'date': '2007-10-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'The change in alanine aminotransferase (ALT) from baseline to the last value in treatment'}, {'measure': 'Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'The change in asparate aminotransferase (AST) from baseline to the last value in treatment'}, {'measure': 'Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'The change in Gamma-glutamyl transferase (Gamma-GT) from baseline to the last value in treatment'}, {'measure': 'Summary of Change From Baseline in Creatinine to Last Value on Treatment', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'The change in Creatinine from baseline to the last value in treatment'}, {'measure': 'Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'The change in total cholesterol from baseline to the last value in treatment'}, {'measure': 'Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'The change in High-density lipoprotein (HDL) cholesterol from baseline to the last value in treatment'}, {'measure': 'Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'The change in Low-density lipoprotein (LDL) cholesterol from baseline to the last value in treatment'}, {'measure': 'Summary of Change From Baseline in Triglycerides to Last Value on Treatment', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'The change in triglycerides from baseline to the last value in treatment'}, {'measure': 'Summary of Change From Baseline in Glucose to Last Value on Treatment', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'The change in Glucose from baseline to the last value in treatment'}], 'secondaryOutcomes': [{'measure': 'Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'For calculation of this measure switch patients are included in the total which had no viral load decrease.'}, {'measure': 'Summary of Change From Baseline in CD4+ Count to Last Value on Treatment', 'timeFrame': 'from baseline to last value on treatment in between 36 months'}, {'measure': 'Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator', 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'Total number of patients with investigator defined non-serious drug-related AEs was reported.'}, {'measure': "Investigator's Global Clinical Assessment of Patient General Health Status", 'timeFrame': 'from baseline to last value on treatment in between 36 months', 'description': 'Investigators opinion of patients general health condition at baseline versus last evaluation on treatment'}]}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1492_Literature.pdf', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with Truvada (tenofovir and emtricitabine) will durably suppress viral load below the limit of detection or will maintain suppression of viral replication (HIV-RNA below limit of detection) achieved under previous anti-retroviral combination therapy after switch to combination treatment of Viramune (nevirapine) and Truvada (tenofovir and emtricitabine).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV Patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* male and female adult HIV type 1 infected patients, who have either not been treated previously, whose previous combination treatment with PIs has failed, or who have to switch their previous treatment from protease inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRT)I due to side effects or intolerability after achieving suppression of viral load below the limit of detection.\n* Viramune (nevirapine) is indicated as part of combination therapy for the antiviral treatment of HIV-1 infected patients with advanced or progressive immunodeficiency.\n* Truvada (tenofovir and emtricitabine) is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.\n\nExclusion criteria\n\n* Age \\< 18 years\n* Pregnant female patients\n* Hypersensitivity to the active substance or to any of the excipients of Viramune (nevirapine) or Truvada (tenofovir and emtricitabine).\n* Viramune (nevirapine) should not be readministered to patients who have required permanent discontinuation for severe rash, rash accompanied by constitutional symptoms, hypersensitivity reactions, or clinical hepatitis due to nevirapine.\n* Viramune (nevirapine) should not be used in patients with severe hepatic impairment (Child-Pugh C) or pre-treatment aspartine transaminase (ASAT) or alanine transaminase (ALAT) \\> 5 upper limit normal (ULN) until baseline ASAT/ALAT are stabilised \\< 5 ULN.\n* Viramune (nevirapine) should not be readministered in patients who previously had ASAT or ALAT \\> 5 ULN during Viramune (nevirapine) therapy and had recurrence of liver function abnormalities upon readministration of Viramune (nevirapine)\n* Herbal preparations containing St Johns wort (Hypericum perforatum) must not be used while taking Viramune (nevirapine) due to the risk of decreased plasma concentrations and reduced clinical effects of nevirapine\n* The available pharmacokinetic data suggest that the concomitant use of rifampicin and Viramune (nevirapine) is not recommended.'}, 'identificationModule': {'nctId': 'NCT00543803', 'briefTitle': 'Observational Non-interventional Study With Viramune® in Combination With Truvada® in HIV-infected Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Observational Non-interventional Study Evaluating the Safety and Efficacy of Truvada + Nevirapine', 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