Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-27 @ 6:53 AM
Study NCT ID:
NCT00524368
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2007-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Compare Effectiveness and Safety of Darunavir/Ritonavir (DRV/Rtv) 800mg/100mg Once Daily Versus DRV/Rtv 600mg/100mg Twice Daily in Early Treatment-Experienced HIV-1 Infected Patients (ODIN)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Mexico', 'Poland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069454', 'term': 'Darunavir'}, {'id': 'D019438', 'term': 'Ritonavir'}], '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'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+32 015 461 497', 'title': 'Medical Leader', 'organization': 'Tibotec Pharmaceuticals, Ireland'}, 'certainAgreement': {'otherDetails': "The Sponsor will not unreasonably withhold consent to publish the data generated in this trial. However, it is the policy of the Sponsor not to allow the investigators to publish their results or findings prior to the Sponsor's publication of the overall trial results. The investigator agrees that before he/she publishes any results of this trial, he/she shall allow at least 45 days for the Sponsor to review the prepublication manuscript prior to submission of the manuscript to the publisher.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '52 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'DRV/Rtv 800/100 mg Once Daily', 'description': 'Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily', 'otherNumAtRisk': 294, 'otherNumAffected': 134, 'seriousNumAtRisk': 294, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'DRV/Rtv 600/100 mg Twice Daily', 'description': 'One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily', 'otherNumAtRisk': 296, 'otherNumAffected': 147, 'seriousNumAtRisk': 296, 'seriousNumAffected': 27}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 66}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dermo-hypodermitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastroenteritis cryptosporidial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mastoiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Peritonitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Toxoplasmosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Extrapulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Infected cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperamylasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lactic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pulmonary bulla', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypoventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bicytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bile duct obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Drug toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Whiplash injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Post procedural bile leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abnormal behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Drug interaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Carotid artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Angiodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vulval ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Intervertebral disc operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 296, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Virological Response at Week 48 (Number of Participants With Plasma Viral Load Less Than 50 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/Rtv 800/100 mg Once Daily', 'description': 'Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily'}, {'id': 'OG001', 'title': 'DRV/Rtv 600/100 mg Twice Daily', 'description': 'One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '212', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion of response', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0019', 'ciLowerLimit': '-0.054', 'ciUpperLimit': '0.092', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.037', 'estimateComment': 'Difference in proportion of response DRV/rtv once daily minus DRV/rtv twice daily estimated from the logistic regression model.', 'groupDescription': 'Assuming a response rate of 70% at 48 weeks for both treatment groups, 306 participants were required per treatment arm to establish noninferiority of darunavir (DRV)/ritonavir (rtv) once daily versus DRV/rtv twice daily with a maximum allowable difference of 12%, with a 1-sided significance level of 0.025 and 90% power.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The model includes treatment as factor and baseline viral load (log10) as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/rtv once daily and DRV/rtv twice daily exceeds -12%, non-inferiority of the DRV/rtv q.d. versus the DRV/rtv b.i.d. therapy was concluded.'}], 'paramType': 'NUMBER', 'timeFrame': '48 Weeks', 'description': 'The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.'}, {'type': 'SECONDARY', 'title': 'Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/Rtv 800/100 mg Once Daily', 'description': 'Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily'}, {'id': 'OG001', 'title': 'DRV/Rtv 600/100 mg Twice Daily', 'description': 'One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '226', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion of response', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.007', 'ciLowerLimit': '-0.060', 'ciUpperLimit': '0.075', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.034', 'estimateComment': 'Difference in proportion of response between 2 treatment groups (DRV/rtv q.d. minus DRV/rtv b.i.d)', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'A logistic regression model includes treatment as fixed factor and baseline plasma viral load as a covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'If at Week 48, the lower limit of this 95% 2-sided CI of the difference between DRV/rtv q.d. and DRV/rtv b.i.d. exceeded -12%, noninferiority of DRV/rtv q.d. and DRV/rtv b.i.d. could be concluded.'}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': 'Number of participants with confirmed plasma viral load less than 400 copies/mL at Week 48.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.'}, {'type': 'SECONDARY', 'title': 'Change in log10 Viral Load From Baseline at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/Rtv 800/100 mg Once Daily', 'description': 'Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily'}, {'id': 'OG001', 'title': 'DRV/Rtv 600/100 mg Twice Daily', 'description': 'One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily'}], 'classes': [{'title': 'Log10 Viral Load at baseline', 'categories': [{'measurements': [{'value': '4.23', 'groupId': 'OG000', 'lowerLimit': '1.73', 'upperLimit': '6.43'}, {'value': '4.134', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '5.98'}]}]}, {'title': 'Log10 Viral Load change from baseline at Week 48', 'categories': [{'measurements': [{'value': '-2.11', 'groupId': 'OG000', 'lowerLimit': '-4.7', 'upperLimit': '2.0'}, {'value': '-2.13', 'groupId': 'OG001', 'lowerLimit': '-4.2', 'upperLimit': '2.4'}]}]}], 'analyses': [{'pValue': '0.977', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference between least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.003', 'ciLowerLimit': '-0.188', 'ciUpperLimit': '0.182', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.094', 'estimateComment': 'Difference between least square means between the DRV/rtv q.d. and DRV/rtv b.i.d. treatment groups at Week 48.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Including 1 factor for treatment, and including the covariate baseline log10 plasma viral load', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '48 weeks', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.'}, {'type': 'SECONDARY', 'title': 'Time to Reach First Virologic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/Rtv 800/100 mg Once Daily', 'description': 'Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily'}, {'id': 'OG001', 'title': 'DRV/Rtv 600/100 mg Twice Daily', 'description': 'One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '86'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '83', 'upperLimit': '85'}]}]}], 'analyses': [{'pValue': '0.917', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.990', 'ciLowerLimit': '0.824', 'ciUpperLimit': '1.191', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.094', 'statisticalMethod': 'Cox proportional hazards', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Including treatment as fixed factor and baseline plasma viral load as a covariate', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '48 weeks', 'description': 'Time (in weeks) to achieve viral load less than 50 copies/mL by the participants.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.'}, {'type': 'SECONDARY', 'title': 'Time to Loss of Virologic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/Rtv 800/100 mg Once Daily', 'description': 'Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily'}, {'id': 'OG001', 'title': 'DRV/Rtv 600/100 mg Twice Daily', 'description': 'One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '250.235', 'spread': '6.598', 'groupId': 'OG000'}, {'value': '281.743', 'spread': '7.47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.716', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.945', 'ciLowerLimit': '0.699', 'ciUpperLimit': '1.279', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.154', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Including baseline log10 viral load as covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '48 weeks', 'description': 'Time taken to lose the virologic response ie, plasma viral load less than 50 copies/mL by participants.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.'}, {'type': 'SECONDARY', 'title': 'Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/Rtv 800/100 mg Once Daily', 'description': 'Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily'}, {'id': 'OG001', 'title': 'DRV/Rtv 600/100 mg Twice Daily', 'description': 'One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.77', 'spread': '0.051', 'groupId': 'OG000'}, {'value': '-1.74', 'spread': '0.051', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.711', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.169', 'ciUpperLimit': '0.115', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.072', 'estimateComment': 'Difference in least square means between the 2 treatment groups (DRV/rtv q.d. and DRV/rtv b.i.d)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Including 1 factor for treatment, and including the covariate baseline log10 plasma viral load', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '48 weeks', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention To Treat (ITT) population: Observed cases'}, {'type': 'SECONDARY', 'title': 'Change in CD4+ Cell Count From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/Rtv 800/100 mg Once Daily', 'description': 'Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily'}, {'id': 'OG001', 'title': 'DRV/Rtv 600/100 mg Twice Daily', 'description': 'One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily'}], 'classes': [{'title': 'Value at Baseline', 'categories': [{'measurements': [{'value': '219', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '1306'}, {'value': '236', 'groupId': 'OG001', 'lowerLimit': '44', 'upperLimit': '864'}]}]}, {'title': 'CD4+ cell count change from baseline at Week 48', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '-242', 'upperLimit': '808'}, {'value': '94', 'groupId': 'OG001', 'lowerLimit': '-239', 'upperLimit': '639'}]}]}], 'analyses': [{'pValue': '0.562', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.95', 'ciLowerLimit': '-26.09', 'ciUpperLimit': '14.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.26', 'estimateComment': 'Difference in least square means DRV/rtv once daily minus DRV/rtv twice daily estimated from the ANCOVA model.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model includes treatment as factor and baseline CD4 count and baseline viral load (log10) as covariates.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '48 Weeks', 'description': 'CD4+ cell count was calculated using the Last Observation Carried Forward (LOCF) algorithm.', 'unitOfMeasure': '10e6/l', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention To Treat (ITT) population - last observation carried forward (LOCF): Intermittent missing values and missing values due to premature discontinuation were imputed with the last observation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/Rtv 800/100 mg Once Daily', 'description': 'Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily'}, {'id': 'OG001', 'title': 'DRV/Rtv 600/100 mg Twice Daily', 'description': 'One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily'}], 'classes': [{'title': 'FAHI score at baseline', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000', 'lowerLimit': '31', 'upperLimit': '175'}, {'value': '123.5', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '174'}]}]}, {'title': 'Change from baseline in FAHI score at Week 48', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '-74', 'upperLimit': '81'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-75', 'upperLimit': '81'}]}]}], 'analyses': [{'pValue': '0.761', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '-2.97', 'ciUpperLimit': '4.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.79', 'estimateComment': 'Difference in least square means DRV/rtv once daily minus DRV/rtv twice daily estimated from the ANCOVA model.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Including factors for treatment, and baseline log10 plasma viral load and baseline FAHI score as covariates', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '48 weeks', 'description': 'The FAHI is a 44-item questionnaire and incorporates 5 functional scales (physical well-being, emotional well-being/living with HIV, functional and global well-being, social well-being, and cognitive functioning). Each scale included several questions (all 5 scales include total 44 questions). For each question, participants gave a score of either 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit) and 4 (very much). Total FAHI imputed score is calculated by adding scores for each question. The range of total FAHI score is 0 to 176. Higher scores indicate worsening.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention To Treat (ITT) population - last observation carried forward (LOCF): Intermittent missing values and missing values due to premature discontinuation were imputed with the last observation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/Rtv 800/100 mg Once Daily', 'description': 'Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily'}, {'id': 'OG001', 'title': 'DRV/Rtv 600/100 mg Twice Daily', 'description': 'One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily'}], 'classes': [{'title': 'Adherent', 'categories': [{'measurements': [{'value': '67.4', 'groupId': 'OG000'}, {'value': '60.3', 'groupId': 'OG001'}]}]}, {'title': 'Non-adherent', 'categories': [{'measurements': [{'value': '32.6', 'groupId': 'OG000'}, {'value': '39.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': 'Self-reported adherence to the ARV medications was measured. The M-MASRI asks participants to report the number of doses taken, as well as the number of doses taken during the last 30 days prior to the study visit by means of a horizontal visual analogue scale (VAS) that generates a self-rated percentage of doses of all the ARV medications taken during the past 30 days.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/Rtv 800/100 mg Once Daily', 'description': 'Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily'}, {'id': 'OG001', 'title': 'DRV/Rtv 600/100 mg Twice Daily', 'description': 'One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily'}], 'classes': [{'title': 'Population Pharmacokinetic Estimates of DRV', 'categories': [{'measurements': [{'value': '87788', 'groupId': 'OG000', 'lowerLimit': '45456', 'upperLimit': '236920'}, {'value': '109401', 'groupId': 'OG001', 'lowerLimit': '48934', 'upperLimit': '323820'}]}]}, {'title': 'Population Pharmacokinetic Estimates of rtv', 'categories': [{'measurements': [{'value': '5776', 'groupId': 'OG000', 'lowerLimit': '1801', 'upperLimit': '39027'}, {'value': '12588', 'groupId': 'OG001', 'lowerLimit': '3404', 'upperLimit': '44762'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48.', 'description': 'Pharmacokinetic parameter AUC24h was assessed from the time of study medication administration upto 24 hour postdose. Population Pharmacokinetic Estimates of DRV and rtv were evaluated.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Predose Plasma Concentration (C0h) of DRV and Rtv.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/Rtv 800/100 mg Once Daily', 'description': 'Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily'}, {'id': 'OG001', 'title': 'DRV/Rtv 600/100 mg Twice Daily', 'description': 'One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily'}], 'classes': [{'title': 'Population Pharmacokinetic Estimates of DRV', 'categories': [{'measurements': [{'value': '1896', 'groupId': 'OG000', 'lowerLimit': '184', 'upperLimit': '7881'}, {'value': '3197', 'groupId': 'OG001', 'lowerLimit': '250', 'upperLimit': '11865'}]}]}, {'title': 'Population Pharmacokinetic Estimates of rtv', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '1049'}, {'value': '307', 'groupId': 'OG001', 'lowerLimit': '41', 'upperLimit': '1657'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48', 'description': 'Pharmacokinetic parameter C0h was assessed. Population Pharmacokinetic Estimates of DRV and rtv were evaluated.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Developing Mutations at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRV/Rtv 800/100 mg Once Daily', 'description': 'Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily'}, {'id': 'OG001', 'title': 'DRV/Rtv 600/100 mg Twice Daily', 'description': 'One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily'}], 'classes': [{'title': 'DRV resistance-associated mutation (RAM)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Primary (major) protease inhibitor (PI) mutations', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Protease inhibitor (PI) RAMs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Nucleoside reverse transcriptase inhibitor RAMs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': 'Development of Mutations in Virologic Failures (Plasma Viral Load less than 50 Copies/mL) at endpoint.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DRV/Rtv 800/100 mg Once Daily', 'description': 'Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily'}, {'id': 'FG001', 'title': 'DRV/Rtv 600/100 mg Twice Daily', 'description': 'One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '294'}, {'groupId': 'FG001', 'numSubjects': '296'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '253'}, {'groupId': 'FG001', 'numSubjects': '248'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '48'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Non-compliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Reached a Virologic Endpoint', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': "Sponsor's Decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Ineligible to Continue the study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'One hundred thirteen investigators in 21 countries participated in this study.', 'preAssignmentDetails': 'In total 1092 participants were screened, of which 590 participants were randomly assigned and treated (294 participants were treated with DRV/rtv 800/100 mg once daily, and 296 participants with DRV/rtv 600/100 mg twice daily.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'BG000'}, {'value': '296', 'groupId': 'BG001'}, {'value': '590', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DRV/Rtv 800/100 mg Once Daily', 'description': 'Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily'}, {'id': 'BG001', 'title': 'DRV/Rtv 600/100 mg Twice Daily', 'description': 'One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.2', 'spread': '9.09', 'groupId': 'BG000'}, {'value': '40.7', 'spread': '9.50', 'groupId': 'BG001'}, {'value': '40.5', 'spread': '9.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '377', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age (years) (categorical)', 'classes': [{'title': 'Age <= 30', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}, {'title': '30 < Age <= 45', 'categories': [{'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '349', 'groupId': 'BG002'}]}]}, {'title': '45 < Age <= 55', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}]}, {'title': '55 < Age <= 65', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Age > 65', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hepatitis B or C Co-infection Status', 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '267', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '522', 'groupId': 'BG002'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 590}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-12', 'studyFirstSubmitDate': '2007-08-30', 'resultsFirstSubmitDate': '2010-08-27', 'studyFirstSubmitQcDate': '2007-08-30', 'lastUpdatePostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-08-27', 'studyFirstPostDateStruct': {'date': '2007-09-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Virological Response at Week 48 (Number of Participants With Plasma Viral Load Less Than 50 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm', 'timeFrame': '48 Weeks', 'description': 'The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.'}], 'secondaryOutcomes': [{'measure': 'Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL)', 'timeFrame': '48 weeks', 'description': 'Number of participants with confirmed plasma viral load less than 400 copies/mL at Week 48.'}, {'measure': 'Change in log10 Viral Load From Baseline at Week 48', 'timeFrame': '48 weeks'}, {'measure': 'Time to Reach First Virologic Response', 'timeFrame': '48 weeks', 'description': 'Time (in weeks) to achieve viral load less than 50 copies/mL by the participants.'}, {'measure': 'Time to Loss of Virologic Response', 'timeFrame': '48 weeks', 'description': 'Time taken to lose the virologic response ie, plasma viral load less than 50 copies/mL by participants.'}, {'measure': 'Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks', 'timeFrame': '48 weeks'}, {'measure': 'Change in CD4+ Cell Count From Baseline', 'timeFrame': '48 Weeks', 'description': 'CD4+ cell count was calculated using the Last Observation Carried Forward (LOCF) algorithm.'}, {'measure': 'Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score', 'timeFrame': '48 weeks', 'description': 'The FAHI is a 44-item questionnaire and incorporates 5 functional scales (physical well-being, emotional well-being/living with HIV, functional and global well-being, social well-being, and cognitive functioning). Each scale included several questions (all 5 scales include total 44 questions). For each question, participants gave a score of either 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit) and 4 (very much). Total FAHI imputed score is calculated by adding scores for each question. The range of total FAHI score is 0 to 176. Higher scores indicate worsening.'}, {'measure': 'Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48', 'timeFrame': '48 weeks', 'description': 'Self-reported adherence to the ARV medications was measured. The M-MASRI asks participants to report the number of doses taken, as well as the number of doses taken during the last 30 days prior to the study visit by means of a horizontal visual analogue scale (VAS) that generates a self-rated percentage of doses of all the ARV medications taken during the past 30 days.'}, {'measure': 'Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv', 'timeFrame': '0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48.', 'description': 'Pharmacokinetic parameter AUC24h was assessed from the time of study medication administration upto 24 hour postdose. Population Pharmacokinetic Estimates of DRV and rtv were evaluated.'}, {'measure': 'Predose Plasma Concentration (C0h) of DRV and Rtv.', 'timeFrame': '0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48', 'description': 'Pharmacokinetic parameter C0h was assessed. Population Pharmacokinetic Estimates of DRV and rtv were evaluated.'}, {'measure': 'Number of Participants Developing Mutations at Endpoint', 'timeFrame': '48 weeks', 'description': 'Development of Mutations in Virologic Failures (Plasma Viral Load less than 50 Copies/mL) at endpoint.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Human immunodeficiency virus - type 1', 'HIV-1 Infection', 'TMC-114', 'Darunavir', 'Ritonavir'], 'conditions': ['Human Immunodeficiency Virus - Type 1']}, 'referencesModule': {'references': [{'pmid': '23558157', 'type': 'DERIVED', 'citation': 'Lathouwers E, De La Rosa G, Van de Casteele T, Baeten B, Tomaka F, De Meyer S, Picchio G. Virological analysis of once-daily and twice-daily darunavir/ritonavir in the ODIN trial of treatment-experienced patients. Antivir Ther. 2013;18(3):289-300. doi: 10.3851/IMP2569. Epub 2013 Apr 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test if being treated with darunavir/ritonavir (DRV/rtv) 800/100 mg daily is as effective as being treated with DRV/rtv 600/100 mg twice daily, in early antiretroviral (ARV)-experienced patients when given along with selected optimized background regimen (OBR).', 'detailedDescription': 'This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention) study in which 590 patients will be randomly assigned to receive either DRV/rtv 800/100 mg daily or DRV/rtv 600/100 mg twice daily along with the selected OBR. An OBR will consist of at least 2 nucleoside reverse transcriptase inhibitors (NRTIs) selected by the investigator. The study will include a 4 week screening period, 48-weeks of treatment period and 4-weeks of follow-up. The study will also consists of extension phase after Week 48: in regions where DRV is not yet commercially available or reimbursed by the health care system, patients who complete the 48 weeks of treatment with DRV/rtv and who continue to benefit from this treatment, will have the opportunity to continue DRV treatment as a 600 mg twice daily dosage until DRV is reimbursed and available via the public and/or private health care system or until its development is discontinued. Safety evaluation will consists of adverse events (including specific toxicities), clinical laboratory tests, vital signs, electrocardiogram, physical and skin examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with documented human immunodeficiency virus - Type 1 (HIV-1) infection\n* Patients with a viral load greater than 1,000 HIV-1 ribonucleic acid (RNA) copies/mL\n* Stable highly active antiretroviral therapy (HAART) regimen for at least 12 weeks at screening\n* In the investigator's opinion, non-nucleoside reverse transcriptase inhibitors (NNRTIs) are not a valid treatment option, because of the patient's antiretroviral (ARV) treatment history, ARV resistance testing, medication-taking behavior, safety and tolerability concerns, or other patient-related factors\n* Prescreening or/and screening plasma HIV-1 RNA greater than 1,000 copies/mL on HAART regimen at screening\n\nExclusion Criteria:\n\n* Presence of any currently active conditions that fit the definition of the World Health Organization (WHO) Clinical Stage 4, with the following exceptions: stable cutaneous kaposi's sarcoma (ie, no internal organ involvement other than oral lesions) that is unlikely to require any form of systemic therapy during the study time period, wasting syndrome\n* Patients for whom an investigational ARV is part of the current regimen, with the following exceptions if applicable (depending on local regulatory approval): tenofovir, emtricitabine\n* Previous or current use of enfuvirtide (ENF), tipranavir and/or DRV\n* Life expectancy of less than 12 months\n* Pregnant or breast-feeding females\n* Any active clinically significant disease (eg, tuberculosis \\[TB\\], cardiac dysfunction, pancreatitis, acute viral infections) 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': 'NCT00524368', 'acronym': 'ODIN', 'briefTitle': 'A Study to Compare Effectiveness and Safety of Darunavir/Ritonavir (DRV/Rtv) 800mg/100mg Once Daily Versus DRV/Rtv 600mg/100mg Twice Daily in Early Treatment-Experienced HIV-1 Infected Patients (ODIN)', 'nctIdAliases': ['NCT00613990'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Tibotec Pharmaceuticals, Ireland'}, 'officialTitle': 'A Randomized, Open-label Trial to Compare the Efficacy, Safety and Tolerability of DRV/Rtv (800mg/100mg) q.d Versus DRV/Rtv (600mg/100mg) b.i.d in Early Treatment-experienced HIV-1 Infected Subjects', 'orgStudyIdInfo': {'id': 'CR013783'}, 'secondaryIdInfos': [{'id': 'TMC114-TiDP31-C229', 'type': 'OTHER', 'domain': 'Tibotec Pharmaceuticals, Ireland'}, {'id': '2007-001939-61', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DRV/rtv 800/100 mg once daily', 'description': 'Two 400 mg darunavir (DRV) ie, TMC114 tablets + one 100 mg ritonavir (rtv) capsule once daily.', 'interventionNames': ['Drug: Darunavir (DRV)', 'Drug: Ritonavir (rtv)']}, {'type': 'EXPERIMENTAL', 'label': 'DRV/rtv 600/100 mg twice daily', 'description': 'One 600 mg TMC114 tablet + one 100 mg capsule of rtv twice daily.', 'interventionNames': ['Drug: Darunavir (DRV)', 'Drug: Ritonavir (rtv)']}], 'interventions': [{'name': 'Darunavir (DRV)', 'type': 'DRUG', 'otherNames': ['TMC114'], 'description': 'DRV/rtv 800/100 mg once daily group: 2 tablets of 400 mg of DRV administered orally once daily. DRV/rtv 600/100 mg twice daily group: 1 tablet of 600 mg DRV administered orally twice daily.', 'armGroupLabels': ['DRV/rtv 600/100 mg twice daily', 'DRV/rtv 800/100 mg once daily']}, {'name': 'Ritonavir (rtv)', 'type': 'DRUG', 'otherNames': ['rtv'], 'description': 'DRV/rtv 800/100 mg once daily group: One capsule of 100 mg of ritonavir administered orally once daily. DRV/rtv 600/100 mg twice daily group: One capsule of 100 mg of ritonavir administered orally twice daily.', 'armGroupLabels': ['DRV/rtv 600/100 mg twice daily', 'DRV/rtv 800/100 mg once daily']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'city': 'Oakland', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'city': 'Fort Laudersale', 'state': 'Florida', 'country': 'United States'}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Safety Harbor', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.99085, 'lon': -82.69316}}, {'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'city': 'Berkley', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.50309, 'lon': -83.18354}}, {'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'city': 'Albany', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Harlingen', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 26.19063, 'lon': -97.6961}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Córdoba', 'country': 'Argentina', 'geoPoint': 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