Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT00876733
Status:
COMPLETED
Last Update Posted:
2015-01-16
First Post:
2009-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Non-Interventional Observational Study With Viramune Plus Antiretroviral 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': "Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '36 months', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.', 'otherNumAtRisk': 288, 'otherNumAffected': 51, 'seriousNumAtRisk': 288, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.', 'otherNumAtRisk': 203, 'otherNumAffected': 33, 'seriousNumAtRisk': 203, 'seriousNumAffected': 12}, {'id': 'EG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.', 'otherNumAtRisk': 93, 'otherNumAffected': 22, 'seriousNumAtRisk': 93, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.', 'otherNumAtRisk': 21, 'otherNumAffected': 3, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Transaminase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}], 'seriousEvents': [{'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Intestinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Hepatotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Acute hepatitis C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Meningoencephalitis herpetic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Myelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Biopsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Hepatic enzyme abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Juvenile idiopathic arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Anogenital warts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Hypopharyngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Hypopharyngeal cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Abortion incomplete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Acute stress disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Anxiety disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Somatoform disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Acute prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Bursa removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Laparoscopic surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Laser therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'title': 'Patients with any AE', 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Patients with serious AEs', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '36 months', 'description': 'Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from Full Analysis Set (FAS): This patient set includes all patients in the treated set who have analysable data in at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Changes in the Viral Load After 12 Months From Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.3', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '1.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The change in the log10 viral load from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a negative change represents a decrease in viral load.', 'unitOfMeasure': 'Log10 copies/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS with values for viral load at baseline and after 12 months.'}, {'type': 'SECONDARY', 'title': 'Changes in the Viral Load After 36 Months From Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '-2.1', 'spread': '1.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 36 months', 'description': 'The change in the log10 viral load from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a negative change represents a decrease in viral load.', 'unitOfMeasure': 'Log10 copies/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS with values for viral load at baseline and after 36 months.'}, {'type': 'SECONDARY', 'title': 'Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'categories': [{'measurements': [{'value': '188.7', 'spread': '165.0', 'groupId': 'OG000'}, {'value': '54.6', 'spread': '145.3', 'groupId': 'OG001'}, {'value': '82.8', 'spread': '269.5', 'groupId': 'OG002'}, {'value': '128.0', 'spread': '223.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The change in the CD4+ cell count from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase in CD4+ cell count.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS with values for CD4+ at baseline and after 12 months.'}, {'type': 'SECONDARY', 'title': 'Changes in the CD4+ Cell Count After 36 Months From Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'categories': [{'measurements': [{'value': '223.7', 'spread': '200.4', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '221.3', 'groupId': 'OG001'}, {'value': '116.0', 'spread': '317.7', 'groupId': 'OG002'}, {'value': '63.5', 'spread': '152.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 36 months', 'description': 'The change in the CD4+ cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase in CD4+ cell count.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS with values for CD4+ at baseline and after 36 months.'}, {'type': 'SECONDARY', 'title': 'Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.2', 'spread': '36.2', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '43.2', 'groupId': 'OG001'}, {'value': '15.8', 'spread': '32.8', 'groupId': 'OG002'}, {'value': '16.4', 'spread': '9.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The changes in the laboratory data (Total Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from TS with evaluable data for Total Cholesterol at baseline and at month 12.'}, {'type': 'SECONDARY', 'title': 'Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '15.0', 'groupId': 'OG001'}, {'value': '10.9', 'spread': '14.9', 'groupId': 'OG002'}, {'value': '-13.2', 'spread': '29.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from TS with evaluable data for HDL Cholesterol at baseline and at month 12.'}, {'type': 'SECONDARY', 'title': 'Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'spread': '29.6', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '35.7', 'groupId': 'OG001'}, {'value': '14.4', 'spread': '30.5', 'groupId': 'OG002'}, {'value': '13.6', 'spread': '10.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from TS with evaluable data for LDL Cholesterol at baseline and at month 12.'}, {'type': 'SECONDARY', 'title': 'Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '106.7', 'groupId': 'OG000'}, {'value': '-61.6', 'spread': '180.2', 'groupId': 'OG001'}, {'value': '-24.0', 'spread': '78.9', 'groupId': 'OG002'}, {'value': '16.3', 'spread': '47.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The changes in the laboratory data (Triglycerides) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from TS with evaluable data for Triglycerides at baseline and at month 12.'}, {'type': 'SECONDARY', 'title': 'Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '20.6', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '16.9', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '24.9', 'groupId': 'OG002'}, {'value': '-8.4', 'spread': '9.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The changes in the laboratory data (Blood Glucose) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from TS with evaluable data for Blood Glucose at baseline and at month 12.'}, {'type': 'SECONDARY', 'title': 'Changes in the Laboratory Data (ALT) After 12 Months From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '28.8', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '28.4', 'groupId': 'OG002'}, {'value': '9.7', 'spread': '33.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from TS with evaluable data for ALT at baseline and at month 12.'}, {'type': 'SECONDARY', 'title': 'Changes in the Laboratory Data (AST) After 12 Months From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '24.7', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '20.9', 'groupId': 'OG002'}, {'value': '8.3', 'spread': '32.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from TS with evaluable data for AST at baseline and at month 12.'}, {'type': 'SECONDARY', 'title': 'Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.9', 'spread': '72.4', 'groupId': 'OG000'}, {'value': '25.4', 'spread': '57.7', 'groupId': 'OG001'}, {'value': '23.7', 'spread': '62.3', 'groupId': 'OG002'}, {'value': '9.1', 'spread': '42.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. 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Therefore, a positive change represents an increase, a negative change represents a decrease in the data.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from TS with evaluable data for Creatinine at baseline and at month 12.'}, {'type': 'SECONDARY', 'title': 'Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '1.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The changes in the laboratory data (Haemoglobin) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from TS with evaluable data for Haemoglobin at baseline and at month 12.'}, {'type': 'SECONDARY', 'title': 'Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.1', 'spread': '39.0', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '44.4', 'groupId': 'OG001'}, {'value': '24.2', 'spread': '42.4', 'groupId': 'OG002'}, {'value': '41.1', 'spread': '12.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 36 months', 'description': 'The changes in the laboratory data (Total Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from TS with evaluable data for Total Cholesterol at baseline and at month 36.'}, {'type': 'SECONDARY', 'title': 'Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '20.7', 'groupId': 'OG001'}, {'value': '11.1', 'spread': '11.9', 'groupId': 'OG002'}, {'value': '-19.6', 'spread': '38.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 36 months', 'description': 'The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. 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Therefore, a positive change represents an increase, a negative change represents a decrease in the data.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from TS with evaluable data for LDL Cholesterol at baseline and at month 36.'}, {'type': 'SECONDARY', 'title': 'Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.4', 'spread': '91.3', 'groupId': 'OG000'}, {'value': '-73.7', 'spread': '252.6', 'groupId': 'OG001'}, {'value': '-17.2', 'spread': '98.0', 'groupId': 'OG002'}, {'value': '34.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 36 months', 'description': 'The changes in the laboratory data (Triglycerides) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from TS with evaluable data for Triglycerides at baseline and at month 36.'}, {'type': 'SECONDARY', 'title': 'Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '27.2', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '19.9', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '36.4', 'groupId': 'OG002'}, {'value': '-7.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 36 months', 'description': 'The changes in the laboratory data (Blood Glucose) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from TS with evaluable data for Blood Glucose at baseline and at month 36.'}, {'type': 'SECONDARY', 'title': 'Changes in the Laboratory Data (ALT) After 36 Months From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.2', 'spread': '107.1', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '33.7', 'groupId': 'OG001'}, {'value': '11.8', 'spread': '27.7', 'groupId': 'OG002'}, {'value': '5.2', 'spread': '26.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 36 months', 'description': 'The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from TS with evaluable data for ALT at baseline and at month 36.'}, {'type': 'SECONDARY', 'title': 'Changes in the Laboratory Data (AST) After 36 Months From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '75.3', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '24.6', 'groupId': 'OG001'}, {'value': '5.5', 'spread': '27.1', 'groupId': 'OG002'}, {'value': '-2.7', 'spread': '19.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 36 months', 'description': 'The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from TS with evaluable data for AST at baseline and at month 36.'}, {'type': 'SECONDARY', 'title': 'Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.3', 'spread': '102.5', 'groupId': 'OG000'}, {'value': '45.0', 'spread': '112.6', 'groupId': 'OG001'}, {'value': '50.3', 'spread': '50.3', 'groupId': 'OG002'}, {'value': '12.9', 'spread': '48.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 36 months', 'description': 'The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from TS with evaluable data for Gamma GT at baseline and at month 36.'}, {'type': 'SECONDARY', 'title': 'Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 36 months', 'description': 'The changes in the laboratory data (Creatinine) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from TS with evaluable data for Creatinine at baseline and at month 12.'}, {'type': 'SECONDARY', 'title': 'Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'OG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'OG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'OG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '1.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 36 months', 'description': 'The changes in the laboratory data (Haemoglobin) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from TS with evaluable data for Haemoglobin at baseline and at month 36.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'FG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'FG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'FG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '288'}, {'groupId': 'FG001', 'numSubjects': '203'}, {'groupId': 'FG002', 'numSubjects': '93'}, {'groupId': 'FG003', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '197'}, {'groupId': 'FG001', 'numSubjects': '161'}, {'groupId': 'FG002', 'numSubjects': '63'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Data not available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '605', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment-naive Patients', 'description': 'Patients who were not pretreated with HIV therapy.'}, {'id': 'BG001', 'title': 'Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL', 'description': 'Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.'}, {'id': 'BG002', 'title': 'Pretreated Patients, Baseline Viral Load > 50 Copies/mL', 'description': 'Patients switching from a virologically ineffective treatment regimen, viral load \\>50 copies/mL.'}, {'id': 'BG003', 'title': 'Patients With Baseline Viral Load Not Documented', 'description': 'Patients who could not be assigned to one of the three subgroups and had no documented viral load value.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.2', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '43.8', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '40.9', 'spread': '9.4', 'groupId': 'BG002'}, {'value': '43.6', 'spread': '7.8', 'groupId': 'BG003'}, {'value': '41.6', 'spread': '9.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '256', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '538', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set (TS): This patient set includes all HIV-1 infected patients who were dispensed Viramune® and were documented to have taken at least one dose of Viramune®and of a antiretroviral combination partner.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 605}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-14', 'studyFirstSubmitDate': '2009-03-20', 'resultsFirstSubmitDate': '2014-12-27', 'studyFirstSubmitQcDate': '2009-04-06', 'lastUpdatePostDateStruct': {'date': '2015-01-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-01-14', 'studyFirstPostDateStruct': {'date': '2009-04-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs', 'timeFrame': '36 months', 'description': 'Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs'}], 'secondaryOutcomes': [{'measure': 'Changes in the Viral Load After 12 Months From Baseline.', 'timeFrame': 'Baseline and 12 months', 'description': 'The change in the log10 viral load from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a negative change represents a decrease in viral load.'}, {'measure': 'Changes in the Viral Load After 36 Months From Baseline.', 'timeFrame': 'Baseline and 36 months', 'description': 'The change in the log10 viral load from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a negative change represents a decrease in viral load.'}, {'measure': 'Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline.', 'timeFrame': 'Baseline and 12 months', 'description': 'The change in the CD4+ cell count from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase in CD4+ cell count.'}, {'measure': 'Changes in the CD4+ Cell Count After 36 Months From Baseline.', 'timeFrame': 'Baseline and 36 months', 'description': 'The change in the CD4+ cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase in CD4+ cell count.'}, {'measure': 'Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline', 'timeFrame': 'Baseline and 12 months', 'description': 'The changes in the laboratory data (Total Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.'}, {'measure': 'Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline', 'timeFrame': 'Baseline and 12 months', 'description': 'The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.'}, {'measure': 'Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline', 'timeFrame': 'Baseline and 12 months', 'description': 'The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.'}, {'measure': 'Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline', 'timeFrame': 'Baseline and 12 months', 'description': 'The changes in the laboratory data (Triglycerides) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.'}, {'measure': 'Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline', 'timeFrame': 'Baseline and 12 months', 'description': 'The changes in the laboratory data (Blood Glucose) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.'}, {'measure': 'Changes in the Laboratory Data (ALT) After 12 Months From Baseline', 'timeFrame': 'Baseline and 12 months', 'description': 'The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.'}, {'measure': 'Changes in the Laboratory Data (AST) After 12 Months From Baseline', 'timeFrame': 'Baseline and 12 months', 'description': 'The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.'}, {'measure': 'Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline', 'timeFrame': 'Baseline and 12 months', 'description': 'The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.'}, {'measure': 'Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline', 'timeFrame': 'Baseline and 12 months', 'description': 'The changes in the laboratory data (Creatinine) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.'}, {'measure': 'Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline', 'timeFrame': 'Baseline and 12 months', 'description': 'The changes in the laboratory data (Haemoglobin) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.'}, {'measure': 'Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline', 'timeFrame': 'Baseline and 36 months', 'description': 'The changes in the laboratory data (Total Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.'}, {'measure': 'Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline', 'timeFrame': 'Baseline and 36 months', 'description': 'The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.'}, {'measure': 'Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline', 'timeFrame': 'Baseline and 36 months', 'description': 'The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.'}, {'measure': 'Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline', 'timeFrame': 'Baseline and 36 months', 'description': 'The changes in the laboratory data (Triglycerides) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.'}, {'measure': 'Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline', 'timeFrame': 'Baseline and 36 months', 'description': 'The changes in the laboratory data (Blood Glucose) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.'}, {'measure': 'Changes in the Laboratory Data (ALT) After 36 Months From Baseline', 'timeFrame': 'Baseline and 36 months', 'description': 'The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.'}, {'measure': 'Changes in the Laboratory Data (AST) After 36 Months From Baseline', 'timeFrame': 'Baseline and 36 months', 'description': 'The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.'}, {'measure': 'Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline', 'timeFrame': 'Baseline and 36 months', 'description': 'The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.'}, {'measure': 'Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline', 'timeFrame': 'Baseline and 36 months', 'description': 'The changes in the laboratory data (Creatinine) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.'}, {'measure': 'Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline', 'timeFrame': 'Baseline and 36 months', 'description': 'The changes in the laboratory data (Haemoglobin) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.'}]}, 'conditionsModule': {'conditions': ['HIV Infections']}, '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 ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or 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 ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* male and female\n* 18 years or older\n* written informed consent\n* The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current information for healthcare professionals / SmPC\n\nExclusion criteria:\n\n* Pregnant patients\n* The exclusion criteria for the treatment of Viramune plus other antiretroviral combination drugs are to be based on the current SmPC'}, 'identificationModule': {'nctId': 'NCT00876733', 'briefTitle': 'Non-Interventional Observational Study With Viramune Plus Antiretroviral in HIV Infected Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Non-Interventional Observational Study With Viramune Plus ARV in HIV Infected Patients', 'orgStudyIdInfo': {'id': '1100.1524'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV treatment'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aachen', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 14', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'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 15', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 19', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 21', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 23', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 24', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 28', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 30', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 31', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 34', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 38', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 41', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 54', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 60', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 63', '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': 'Bochum', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 58', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 50', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 53', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 61', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Dortmund', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 48', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'city': 'Duisburg', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 27', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 49', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 62', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 9', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 32', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 59', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 65', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 57', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Fürth', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 56', 'geoPoint': {'lat': 49.47593, 'lon': 10.98856}}, {'city': 'Giessen', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 29', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'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 42', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 47', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 51', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 40', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 43', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 46', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Karlsruhe', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 6', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'city': 'Koblenz', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 25', 'geoPoint': {'lat': 50.35357, 'lon': 7.57883}}, {'city': 'Krefeld', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 37', 'geoPoint': {'lat': 51.33645, 'lon': 6.55381}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 11', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Mainz', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 52', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'München', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 18', 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