Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT00458302
Status:
COMPLETED
Last Update Posted:
2012-12-19
First Post:
2007-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Poland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], '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'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069454', 'term': 'Darunavir'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D005663', 'term': 'Furans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+49 7624 907580', 'title': 'EMEA Medical Affairs Director Virology', 'organization': 'Jan-Cilag Germany'}, 'certainAgreement': {'otherDetails': 'Sponsor (SP) shall have the 1st right to present the Data without approval from the Principal Investigator (PI). If no publication is submitted by SP within 12 months after closure, or after SP confirms there will be no publication, the PI shall have the right to publish. Prior to submission, the PI will provide the SP with at least 45 days for review of a manuscript. If requested, the PI will withhold such publication for up to an additional 60 days to allow for filing of a patent application', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study was not blinded and not designed to demonstrate a safety benefit to stopping nucleoside analogues.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group).', 'description': 'Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.', 'eventGroups': [{'id': 'EG000', 'title': 'DRV/r+2NRTIs', 'description': '800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks', 'otherNumAtRisk': 129, 'otherNumAffected': 98, 'seriousNumAtRisk': 129, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'DRV/r', 'description': '800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks', 'otherNumAtRisk': 127, 'otherNumAffected': 103, 'seriousNumAtRisk': 127, 'seriousNumAffected': 14}, {'id': 'EG002', 'title': 'Total', 'otherNumAtRisk': 256, 'otherNumAffected': 201, 'seriousNumAtRisk': 256, 'seriousNumAffected': 28}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 52}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 19}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Leukocyturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 13}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 25}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood Cholesterol Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hepatitis A', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Subcutaneous Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hepatitis C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Neurosyphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Secondary Syphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': "Hodgkin's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Tongue Neoplasm Malignant Stage Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nervous System Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Duodenal Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Csf Pressure Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Lipase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Somatoform Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Psychotic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cataract Operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Varicose Vein Operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Femoral Neck Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Incisional Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Procedural Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Benign Prostatic Hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Virological Response [Per Protocol (PP) - Time to Loss of Virologic Response (TLOVR), < 50 Copies/ml, Week 48]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/r+2NRTIs', 'description': '800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks'}, {'id': 'OG001', 'title': 'DRV/r', 'description': '800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion of response', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-10.1', 'ciUpperLimit': '6.8', 'estimateComment': 'Difference in proportion of response DRV/r minus DRV/r+2NRTIs.', 'groupDescription': 'Assuming a virologic response rate of 90% at 48 weeks for both treatment arms, 111 patients were required per treatment arm to establish non-inferiority of DRV/r versus triple regimen with a maximum allowable difference of 12%, with a one-sided significance level of p=0.025 and 80% power. To account for a maximum of 10% major protocol violations that would be excluded from the on-protocol analysis, 125 patients were recruited in each treatment arm, so 250 patients in total.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The primary comparison was performed at Week 48. If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/r and DRV/r+2NRTIs exceeds -12%, non-inferiority of the DRV/r 800/100 once a day (O.D) monotherapy versus the DRV/r 800/100 mg O.D. plus two NRTIs triple combination therapy was concluded.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'Virological response is defined as the number of patients in the PP population with a plasma viral load \\< 50 HIV RNA copies/ml at Week 48. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure\\* (referred to as a Switch Equals Failure analysis). \\*Discontinuations and rechallenge with NRTIs are taken into account until Week 48', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population: all randomised patients who took study drug, and who did not deviate from the protocol.This excludes 10 patients with major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Virological Response [Intent To Treat (ITT) - TLOVR, < 50 Copies/ml, Week 48]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/r+2NRTIs', 'description': '800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks'}, {'id': 'OG001', 'title': 'DRV/r', 'description': '800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion of response', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-9.9', 'ciUpperLimit': '7.8', 'estimateComment': 'Difference in proportion of response DRV/r minus DRV/r+2NRTIs.', 'groupDescription': 'Assuming a virologic response rate of 90% at 48 weeks for both treatment arms, 111 patients were required per treatment arm to establish non-inferiority of DRV/r versus triple regimen with a maximum allowable difference of 12%, with a one-sided significance level of p=0.025 and 80% power. To account for a maximum of 10% major protocol violations that would be excluded from the on-protocol analysis, 125 patients were recruited in each treatment are, so 250 patients in total.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/r and DRV/r+2NRTIs exceeds -12%, non-inferiority of the DRV/r 800/100 once a day (O.D) monotherapy versus the DRV/r 800/100 mg O.D. plus two NRTIs triple combination therapy was concluded.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'Virological response is defined as the number of patients in the ITT population with a plasma viral load \\< 50 HIV RNA copies/ml at Week 48. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure\\* (referred to as a Switch Equals Failure analysis). \\*Discontinuations and rechallenge with NRTIs are taken into account until start of Week 48 window', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all randomised patients who took study drug, regardless of their compliance with the protocol.'}, {'type': 'SECONDARY', 'title': 'Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, < 50 Copies/ml, Week 144]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/r+2NRTIs', 'description': '800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks'}, {'id': 'OG001', 'title': 'DRV/r', 'description': '800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 144', 'description': 'Virological response is defined as the number of patients in the PP population with a plasma viral load \\< 50 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure\\* (referred to as a Switch Equals Failure analysis). \\*Discontinuations and rechallenge with NRTIs are taken into account until Week 144', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population: all randomised subjects who took study drug, and who did not deviate from the protocol.This excludes 13 subjects with major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Virological Response [Intent To Treat (ITT), TLOVR - All Switches Included, < 50 Copies/ml, Week 144]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/r+2NRTIs', 'description': '800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks'}, {'id': 'OG001', 'title': 'DRV/r', 'description': '800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion of response', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '-7.99', 'ciUpperLimit': '10.58', 'estimateComment': 'Difference in proportion of response DRV/r minus DRV/r+2NRTIs.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 144', 'description': 'Virological response is defined as the number of patients in the ITT population with a plasma viral load \\< 50 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). All switches included means that all data even after any changes of treatment were kept. \\*Discontinuations and rechallenge with NRTIs are taken into account until start of Week 144 window.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all randomised patients who took study drug, regardless of their compliance with the protocol.'}, {'type': 'SECONDARY', 'title': 'Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, <200 Copies/ml, Week 144]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/r+2NRTIs', 'description': '800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks'}, {'id': 'OG001', 'title': 'DRV/r', 'description': '800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 144', 'description': 'Virological response is defined as the number of patients in the PP population with a plasma viral load \\< 200 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure\\* (referred to as a Switch Equals Failure analysis). \\*Discontinuations and rechallenge with NRTIs are taken into account until Week 144', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population: all randomised patients who took study drug, and who did not deviate from the protocol. This excludes 13 patients with major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in CD4+ Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/r+2NRTIs', 'description': '800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks'}, {'id': 'OG001', 'title': 'DRV/r', 'description': '800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks'}], 'classes': [{'title': 'week 4', 'categories': [{'measurements': [{'value': '-16.9', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '-32.9', 'spread': '14.6', 'groupId': 'OG001'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '-23.6', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '-20.7', 'spread': '15.2', 'groupId': 'OG001'}]}]}, {'title': 'week 24', 'categories': [{'measurements': [{'value': '-5.4', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '-35.8', 'spread': '14.2', 'groupId': 'OG001'}]}]}, {'title': 'week 36', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '-21.1', 'spread': '14.3', 'groupId': 'OG001'}]}]}, {'title': 'week 48', 'categories': [{'measurements': [{'value': '-19.0', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '-15.1', 'spread': '16.0', 'groupId': 'OG001'}]}]}, {'title': 'week 60', 'categories': [{'measurements': [{'value': '-4.0', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '14.4', 'groupId': 'OG001'}]}]}, {'title': 'week 72', 'categories': [{'measurements': [{'value': '24.1', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '-12.3', 'spread': '14.3', 'groupId': 'OG001'}]}]}, {'title': 'week 84', 'categories': [{'measurements': [{'value': '34.6', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '15.0', 'groupId': 'OG001'}]}]}, {'title': 'week 96', 'categories': [{'measurements': [{'value': '49.1', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '54.8', 'spread': '16.2', 'groupId': 'OG001'}]}]}, {'title': 'week 112', 'categories': [{'measurements': [{'value': '106.0', 'spread': '16.7', 'groupId': 'OG000'}, {'value': '87.5', 'spread': '16.2', 'groupId': 'OG001'}]}]}, {'title': 'week 128', 'categories': [{'measurements': [{'value': '117.3', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '90.4', 'spread': '14.9', 'groupId': 'OG001'}]}]}, {'title': 'week 144', 'categories': [{'measurements': [{'value': '99.3', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '94.9', 'spread': '15.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at week 4, 12, 24, 36, 48, 60, 72, 84, 96, 112, 128, 144', 'description': 'The mean change in CD4+ cell count from baseline was calculated with a last observation carried forward method; i.e. the last observed value was carried forward, irrespective of the reason for discontinuation.', 'unitOfMeasure': 'number of cells/L (x10^6)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT: all randomized patients who had at least 1 dose of study medication, regardless of their adherence to the protocol'}, {'type': 'SECONDARY', 'title': 'Resistance Determinations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/r+2NRTIs', 'description': '800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks'}, {'id': 'OG001', 'title': 'DRV/r', 'description': '800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks'}], 'classes': [{'title': '>= 1 HIV-1 RNA > 50 copies/mL', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': '>= 1 successful genotype after baseline', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': '>= 1 IAS-USA primary PI mutations', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '>= 1 DRV RAMs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'NRTI RAMs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'M184V mutation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'no primary PI, DRV, NRTI or M184 V mutations', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at each visit from baseline to week 144', 'description': 'Number of patients with resistance mutations at any time point when a patient had a viral load \\> 50 copies/mL after randomization.', 'unitOfMeasure': 'number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT: all randomised patients who had at least 1 dose of study medication, regardless of their adherence to the protocol.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/r+2NRTIs', 'description': '800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks'}, {'id': 'OG001', 'title': 'DRV/r', 'description': '800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks'}], 'classes': [{'title': 'week 48', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'week 96', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'week 144', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, week 48, 96 and 144', 'description': 'The FAHI is a validated health-related quality of life questionnaire. The questionnaire consist of 44 items and includes 5 functional scales (physical, social, emotional, functional and global well-being and cognitive function). Each item is assessing the impact of HIV on a scale from 0 (not at all) to 5 (very much).', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Cognitive Function Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/r+2NRTIs', 'description': '800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks'}, {'id': 'OG001', 'title': 'DRV/r', 'description': '800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks'}], 'classes': [{'title': 'week 48', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'week 96', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'week 144', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, week 48, 96 and 144', 'description': 'The FAHI cognitive function subscale. Each item is assessing the impact of HIV on cognitive function on a scale from 0 (not at all) to 5 (very much).', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Emotional Well-Being Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/r+2NRTIs', 'description': '800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks'}, {'id': 'OG001', 'title': 'DRV/r', 'description': '800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks'}], 'classes': [{'title': 'week 48', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'week 96', 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'week 144', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, week 48, 96 and 144', 'description': 'The FAHI emotional well-being subscale. Each item is assessing the impact of HIV on emotional well-being on a scale from 0 (not at all) to 5 (very much).', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Functional and Global Well-Being Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/r+2NRTIs', 'description': '800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks'}, {'id': 'OG001', 'title': 'DRV/r', 'description': '800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks'}], 'classes': [{'title': 'week 48', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'week 96', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'week 144', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, week 48, 96 and 144', 'description': 'The FAHI functional and global well-being subscale. Each item is assessing the impact of HIV on functional and global well-being on a scale from 0 (not at all) to 5 (very much).', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Physical Well-Being Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/r+2NRTIs', 'description': '800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks'}, {'id': 'OG001', 'title': 'DRV/r', 'description': '800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks'}], 'classes': [{'title': 'week 48', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'week 96', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'week 144', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, week 48, 96 and 144', 'description': 'The FAHI physical well-being subscale. Each item is assessing the impact of HIV on physical well-being on a scale from 0 (not at all) to 5 (very much).', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Social Well-Being Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/r+2NRTIs', 'description': '800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks'}, {'id': 'OG001', 'title': 'DRV/r', 'description': '800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks'}], 'classes': [{'title': 'week 48', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'week 96', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'week 144', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, week 48, 96 and 144', 'description': 'The FAHI social well-being subscale. Each item is assessing the impact of HIV on physical well-being on a scale from 0 (not at all) to 5 (very much).', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DRV/r+2NRTIs', 'description': '800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks'}, {'id': 'FG001', 'title': 'DRV/r', 'description': '800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '127'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '103'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Inc/Exc Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Study Termination By Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'xxxxx'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '256', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DRV/r+2NRTIs', 'description': '800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks'}, {'id': 'BG001', 'title': 'DRV/r', 'description': '800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.1', 'spread': '9.74', 'groupId': 'BG000'}, {'value': '43.4', 'spread': '9.14', 'groupId': 'BG001'}, {'value': '43.7', 'spread': '9.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'AUSTRIA', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'BELGIUM', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'DENMARK', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'GERMANY', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'HUNGARY', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'ISRAEL', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'ITALY', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'POLAND', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'PORTUGAL', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'RUSSIAN FEDERATION', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'SPAIN', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'SWITZERLAND', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'UNITED KINGDOM', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'plasma viral load', 'classes': [{'title': '< 50', 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}]}]}, {'title': '50-400', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': '400-1000', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '> 1000', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'plasma viral load (HIV-1 RNA copies/ml)', 'unitOfMeasure': 'participants'}, {'title': 'CD4+ cell count (absolute count)', 'classes': [{'categories': [{'measurements': [{'value': '579.0', 'groupId': 'BG000', 'lowerLimit': '163', 'upperLimit': '1888'}, {'value': '571.0', 'groupId': 'BG001', 'lowerLimit': '162', 'upperLimit': '1451'}, {'value': '573.5', 'groupId': 'BG002', 'lowerLimit': '162', 'upperLimit': '1888'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells/µl', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 256}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-14', 'studyFirstSubmitDate': '2007-04-06', 'resultsFirstSubmitDate': '2010-02-04', 'studyFirstSubmitQcDate': '2007-04-06', 'lastUpdatePostDateStruct': {'date': '2012-12-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-04', 'studyFirstPostDateStruct': {'date': '2007-04-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Virological Response [Per Protocol (PP) - Time to Loss of Virologic Response (TLOVR), < 50 Copies/ml, Week 48]', 'timeFrame': 'Week 48', 'description': 'Virological response is defined as the number of patients in the PP population with a plasma viral load \\< 50 HIV RNA copies/ml at Week 48. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure\\* (referred to as a Switch Equals Failure analysis). \\*Discontinuations and rechallenge with NRTIs are taken into account until Week 48'}], 'secondaryOutcomes': [{'measure': 'Virological Response [Intent To Treat (ITT) - TLOVR, < 50 Copies/ml, Week 48]', 'timeFrame': 'Week 48', 'description': 'Virological response is defined as the number of patients in the ITT population with a plasma viral load \\< 50 HIV RNA copies/ml at Week 48. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure\\* (referred to as a Switch Equals Failure analysis). \\*Discontinuations and rechallenge with NRTIs are taken into account until start of Week 48 window'}, {'measure': 'Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, < 50 Copies/ml, Week 144]', 'timeFrame': 'Week 144', 'description': 'Virological response is defined as the number of patients in the PP population with a plasma viral load \\< 50 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure\\* (referred to as a Switch Equals Failure analysis). \\*Discontinuations and rechallenge with NRTIs are taken into account until Week 144'}, {'measure': 'Virological Response [Intent To Treat (ITT), TLOVR - All Switches Included, < 50 Copies/ml, Week 144]', 'timeFrame': 'Week 144', 'description': 'Virological response is defined as the number of patients in the ITT population with a plasma viral load \\< 50 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). All switches included means that all data even after any changes of treatment were kept. \\*Discontinuations and rechallenge with NRTIs are taken into account until start of Week 144 window.'}, {'measure': 'Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, <200 Copies/ml, Week 144]', 'timeFrame': 'week 144', 'description': 'Virological response is defined as the number of patients in the PP population with a plasma viral load \\< 200 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure\\* (referred to as a Switch Equals Failure analysis). \\*Discontinuations and rechallenge with NRTIs are taken into account until Week 144'}, {'measure': 'Mean Change From Baseline in CD4+ Cell Count', 'timeFrame': 'at week 4, 12, 24, 36, 48, 60, 72, 84, 96, 112, 128, 144', 'description': 'The mean change in CD4+ cell count from baseline was calculated with a last observation carried forward method; i.e. the last observed value was carried forward, irrespective of the reason for discontinuation.'}, {'measure': 'Resistance Determinations', 'timeFrame': 'at each visit from baseline to week 144', 'description': 'Number of patients with resistance mutations at any time point when a patient had a viral load \\> 50 copies/mL after randomization.'}, {'measure': 'Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Total Score', 'timeFrame': 'at baseline, week 48, 96 and 144', 'description': 'The FAHI is a validated health-related quality of life questionnaire. The questionnaire consist of 44 items and includes 5 functional scales (physical, social, emotional, functional and global well-being and cognitive function). Each item is assessing the impact of HIV on a scale from 0 (not at all) to 5 (very much).'}, {'measure': 'Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Cognitive Function Subscale', 'timeFrame': 'at baseline, week 48, 96 and 144', 'description': 'The FAHI cognitive function subscale. Each item is assessing the impact of HIV on cognitive function on a scale from 0 (not at all) to 5 (very much).'}, {'measure': 'Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Emotional Well-Being Subscale', 'timeFrame': 'at baseline, week 48, 96 and 144', 'description': 'The FAHI emotional well-being subscale. Each item is assessing the impact of HIV on emotional well-being on a scale from 0 (not at all) to 5 (very much).'}, {'measure': 'Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Functional and Global Well-Being Subscale', 'timeFrame': 'at baseline, week 48, 96 and 144', 'description': 'The FAHI functional and global well-being subscale. Each item is assessing the impact of HIV on functional and global well-being on a scale from 0 (not at all) to 5 (very much).'}, {'measure': 'Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Physical Well-Being Subscale', 'timeFrame': 'at baseline, week 48, 96 and 144', 'description': 'The FAHI physical well-being subscale. Each item is assessing the impact of HIV on physical well-being on a scale from 0 (not at all) to 5 (very much).'}, {'measure': 'Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Social Well-Being Subscale', 'timeFrame': 'at baseline, week 48, 96 and 144', 'description': 'The FAHI social well-being subscale. Each item is assessing the impact of HIV on physical well-being on a scale from 0 (not at all) to 5 (very much).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'Monotherapy', 'Darunavir', 'Protease inhibitor', 'Early pre-treated', 'Undetectable', 'Treatment Experienced'], 'conditions': ['HIV Infections', 'AIDS Virus', 'Human Immunodeficiency Virus', 'Acquired Immunodeficiency Syndrome Virus']}, 'referencesModule': {'references': [{'pmid': '20010070', 'type': 'DERIVED', 'citation': 'Arribas JR, Horban A, Gerstoft J, Fatkenheuer G, Nelson M, Clumeck N, Pulido F, Hill A, van Delft Y, Stark T, Moecklinghoff C. The MONET trial: darunavir/ritonavir with or without nucleoside analogues, for patients with HIV RNA below 50 copies/ml. AIDS. 2010 Jan 16;24(2):223-30. doi: 10.1097/QAD.0b013e3283348944.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg once a day (O.D.) as a monotherapy versus a triple combination therapy containing 2 nucleosides and darunavir/ritonavir in 250 HIV-1 infected patients who have been on Highly Active Antiretroviral Therapy (HAART) and have plasma viral load below 50 copies/ml for at least 24 weeks.', 'detailedDescription': 'This study is randomised (patients are assigned different treatments based on chance), controlled, open-label trial to compare the efficacy, safety and tolerability of darunavir/ritonavir (DRV/r) 800/100 mg once a day (O.D.) as a monotherapy versus a triple combination therapy containing 2 nucleosides and DRV/r in 250 HIV-1 infected patients. Patients will be considered eligible if they have not changed any antiretroviral drugs for at least 8 weeks prior to screening and have documented evidence of plasma viral load (or plasma HIV-1 RNA) \\< 50 copies/mL for at least 24 weeks prior to being screened. The trial will consist of a screening period up to 4 weeks, a 48-week treatment period, followed by a 4-week follow-up (FU) period. The primary objective is to demonstrate non-inferiority in efficacy of DRV/r versus the triple combination therapy containing DRV/r, with respect to confirmed virologic response, defined as plasma HIV-1 RNA \\< 50 copies/mL at 48 weeks.Patients will be assigned a study medication based on a 1:1 ratio to either switch to a triple combination therapy containing 2 nucleosides and DRV/r 800/100 mg O.D, or initiate monotherapy with DRV/r 800/100 mg O.D. Patients in the triple combination arm who are already on 2 nucleosides prior to randomisation may remain on these or switch them at baseline. Patients randomised to the monotherapy arm will discontinue Highly Active Antiretroviral Therapy (HAART) at baseline and commence DRV/r 800/100 mg O.D. A Data and Safety Monitoring Board (DSMB) has been commissioned for this study. The role of the DSMB is to review the progress of the trial and the accumulating data to detect evidence of early safety issues for the patients while the trial is ongoing. An interim analysis will be performed after 24 weeks of treatment. The results of the Week 24 analysis will be used to determine whether long-term follow-up to 72 and 96 weeks will be done. The protease inhibitor (PI) component of the regimen cannot be changed until the end of the treatment period and the nucleoside reverse transcriptase inhibitors (NRTIs) cannot be modified until the end of the treatment period with the following exception: single antiretroviral (ARV) substitutions will be allowed for tolerability/toxicity reasons, as long as this can be linked to an adverse event (AE) or an serious adverse event (SAE). After withdrawal of the patient from the trial, changes in the ARV regimen are allowed after the assessments of the withdrawal visit have been performed.\n\nTemporary interruption of all ARVs will be allowed in the event of suspected toxicity, as long as the temporary interruption is associated with and can be linked to an AE or a SAE. For the control arm, the nucleoside analogues could be re-optimized at baseline or on study, and all approved ARVs allowed. However, PIs other than DRV/r are not allowed during the treatment period. Patients who cannot resume study medication will have to be withdrawn. A physical examination will be done at protocol-scheduled visits and vital signs will be monitored at each study visit. In addition, at each study visit, every patient will be asked about the occurrence of or change to AEs since they were last seen by the investigator. Laboratory samples for haematology and serum chemistry will be drawn and the results determined and transmitted to the investigator. Urinalysis will be performed. Pregnancy test will be done at each visit for female participants of child-bearing potential. The primary endpoint will be the proportion with virologic response, defined as a confirmed plasma HIV-1 RNA \\< 50 copies/mL at Week 48.The study hypothesis is that DRV/r monotherapy will be as effective as a triple combination regimen and will be well tolerated in this early pre-treated HIV-1 patients. Two 400mg tablets of darunavir once daily orally within 30 minutes after completion of a meal for 48 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with documented HIV-1 infection\n* Patients currently receiving HAART for at least 24 weeks\n* Plasma viral load \\< 50 copies/mL for at least 24 weeks prior to screening (two results must be documented)\n* Patients taking the same antiretroviral combination for at least 8 weeks before screening\n* Patients and physician's preference to change the current HAART regimen for reasons of simplification and/or toxicity\n* CD4 \\> 100/mm3 at the start of HAART and \\> 200/mm3 at screening.\n\nExclusion Criteria:\n\n* No history of virological failure defined as two consecutive plasma HIV-1 RNA \\> 500 copies/mL while on previous or current antiretroviral therapy\n* No history of any primary PI mutations as defined by the IAS-USA guidelines 2006\n* No patients co-infected with hepatitis B\n* No pregnant or breastfeeding women\n* No active clinically significant disease or life threatening disease or findings during screening of medical history or physical examination that, in the investigator's opinion, would compromise the patient's safety or outcome of the study."}, 'identificationModule': {'nctId': 'NCT00458302', 'acronym': 'MONET', 'briefTitle': 'Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen-Cilag International NV'}, 'officialTitle': 'A Randomised, Controlled, Open-label Trial to Compare the Efficacy, Safety and Tolerability of a Treatment Simplification by Darunavir/Ritonavir (DRV/r) 800/100 mg O.D. vs a Triple Combination Therapy With DRV/r in HIV-1 Infected Patients With Undetectable Plasma HIV-RNA on Their Current Treatments.', 'orgStudyIdInfo': {'id': 'CR013159'}, 'secondaryIdInfos': [{'id': 'TMC114HIV3006', 'type': 'OTHER', 'domain': 'Janssen-Cilag International NV'}, {'id': '2006-006437-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'darunavir monotherapy', 'description': 'darunavir (DRV, TMC114) 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks', 'interventionNames': ['Drug: darunavir (DRV, TMC114)']}, {'type': 'EXPERIMENTAL', 'label': 'darunavir + 2 NRTI', 'description': 'darunavir (DRV, TMC114) 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks', 'interventionNames': ['Drug: darunavir (DRV, TMC114)']}], 'interventions': [{'name': 'darunavir (DRV, TMC114)', 'type': 'DRUG', 'description': '800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks', 'armGroupLabels': ['darunavir + 2 NRTI']}, {'name': 'darunavir (DRV, TMC114)', 'type': 'DRUG', 'description': '800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks', 'armGroupLabels': ['darunavir monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Antwerp', 'country': 'Belgium', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Brussels', 'country': 'Belgium', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Aarhus', 'country': 'Denmark', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Copenhagen', 'country': 'Denmark', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Hvidovre', 'country': 'Denmark', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'city': 'Odense', 'country': 'Denmark', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Frankfurt', 'country': 'Germany', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Hamburg', 'country': 'Germany', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hanover', 'country': 'Germany', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Kÿln N/A', 'country': 'Germany'}, {'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Jerusalem', 'country': 'Israel', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Tel Aviv', 'country': 'Israel', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Tel Litwinsky', 'country': 'Israel', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'city': 'Lisbon', 'country': 'Portugal', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Porto', 'country': 'Portugal', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Donostia Guipuzcoa', 'country': 'Spain'}, {'city': 'Granada', 'country': 'Spain', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Valladolid', 'country': 'Spain', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'city': 'Sankt Gallen', 'country': 'Switzerland', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Janssen-Cilag International NV Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen-Cilag International NV'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen-Cilag International NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}