Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-01 @ 5:14 PM
Study NCT ID:
NCT00035932
Status:
COMPLETED
Last Update Posted:
2010-12-24
First Post:
2002-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069446', 'term': 'Atazanavir Sulfate'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D019258', 'term': 'Saquinavir'}, {'id': 'D061466', 'term': 'Lopinavir'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'title': 'BMS Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The AE data below represents data from start of study in November 2001 through the last locked database of the study, 18 November 2009.', 'eventGroups': [{'id': 'EG000', 'title': 'ATV300/RTV', 'description': 'atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg + tenofovir (TDF) 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study', 'otherNumAtRisk': 119, 'otherNumAffected': 101, 'seriousNumAtRisk': 119, 'seriousNumAffected': 22}, {'id': 'EG001', 'title': 'ATV400/SQV', 'description': 'ATV 400 mg + saquinavir (SQV) 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study', 'otherNumAtRisk': 110, 'otherNumAffected': 95, 'seriousNumAtRisk': 110, 'seriousNumAffected': 22}, {'id': 'EG002', 'title': 'LPV/RTV', 'description': 'lopinavir (LPV)/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study', 'otherNumAtRisk': 118, 'otherNumAffected': 104, 'seriousNumAtRisk': 118, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'OCULAR ICTERUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LIPASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BLOOD BILIRUBIN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BLOOD TRIGLYCERIDES INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 14}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'JAUNDICE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HYPERBILIRUBINAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HYPERSENSITIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HYPOAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'NEUROPATHY PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 63}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'FLATULENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ABDOMINAL DISTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HYPERTRIGLYCERIDAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LIPOATROPHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LIPODYSTROPHY ACQUIRED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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{'term': 'PROSTATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'OVARIAN CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'VAGINAL PROLAPSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MENSTRUATION IRREGULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'OVERDOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HEAD INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HIP FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'FOOT FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'FEMUR FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SPINAL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SUBDURAL HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LOWER LIMB FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'FEMORAL NECK FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LUMBAR VERTEBRAL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'OSTEONECROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'INTERVERTEBRAL DISC PROTRUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HAEMOPTYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'RESPIRATORY DISTRESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CHILLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MALAISE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LYMPHOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ANAL CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': "NON-HODGKIN'S LYMPHOMA", 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SQUAMOUS CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CARCINOID TUMOUR OF THE GASTROINTESTINAL TRACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.86', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-1.52', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '-1.89', 'spread': '0.11', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Time-Averaged Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.14', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.37', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The time-averaged difference (TAD) in the reduction of log10 HIV RNA levels from baseline through Week 24 was compared pairwise for each atazanavir regimen to the lopinavir/RTV regimen, and assessed using a two-sided 97.5% confidence interval. The primary efficacy analysis was to declare two treatment regimens similar if the upper limit of this 97.5% confidence interval for the difference (atazanavir-lopinavir/RTV) was less than 0.5 log10.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Time-Averaged Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.31', 'ciLowerLimit': '0.07', 'ciUpperLimit': '0.55', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The time-averaged difference (TAD) in the reduction of log10 HIV RNA levels from baseline through Week 24 was compared pairwise for each atazanavir regimen to the lopinavir/RTV regimen, and assessed using a two-sided 97.5% confidence interval. The primary efficacy analysis was to declare two treatment regimens similar if the upper limit of this 97.5% confidence interval for the difference (atazanavir-lopinavir/RTV) was less than 0.5 log10.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'log10 c/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in HIV RNA at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.18', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-1.14', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '-1.30', 'spread': '0.06', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.30', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.35', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2', 'unitOfMeasure': 'log10 c/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants, as-randomized (refers to the treatment regimen assigned at randomization).'}, {'type': 'SECONDARY', 'title': 'Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'title': 'Overall (n=120, 115, 123)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}]}, {'title': 'PI Sensitive (n=88, 83, 88)', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}]}, {'title': 'PI Resistant (n=32, 30, 33)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24', 'description': 'Number of participants with a \\>=0.5 log10 decrease in HIV RNA from baseline or HIV RNA \\< 400 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Participants Analyzed=Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization); n=number of evaluable (overall, PI sensitive, PI resistant) participants.'}, {'type': 'SECONDARY', 'title': 'Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'title': 'Overall (n=120, 115, 123)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}]}, {'title': 'PI Sensitive (n=88, 84, 88)', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}, {'title': 'PI Resistant (n=32, 30, 33)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 48', 'description': 'Number of participants with a \\>=0.5 log10 decrease in HIV RNA from baseline or HIV RNA \\< 400 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Participants Analyzed=Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).n=number of evaluable (overall, PI sensitive, PI resistant) participants.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in HIV RNA at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.93', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-1.55', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-1.87', 'spread': '0.13', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Time-Averaged Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.13', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.39', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Time-Averaged Distance', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.33', 'ciLowerLimit': '0.07', 'ciUpperLimit': '0.60', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'unitOfMeasure': 'log10 c/mL', 'dispersionType': 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[{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-13.3', 'ciUpperLimit': '12.3', 'estimateComment': 'ATV 300/RTV - LPV/RTV', 'groupDescription': 'Randomized participants', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 96', 'description': 'Number of participants with a \\>=0.5 log10 decrease in HIV RNA from baseline or HIV RNA \\< 400 c/mL at Week 96.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed case analysis: Randomized participants (while on initial regimen--completers censored) with baseline and on-study measurement.'}, {'type': 'SECONDARY', 'title': 'Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 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for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.0', 'ciLowerLimit': '-16.9', 'ciUpperLimit': '7.0', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': 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label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 48', 'description': 'Number of participants with a \\>=0.5 log10 decrease in HIV RNA from baseline or HIV RNA \\< 50 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As there were multiple efficacy algorithms run and multiple 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The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants, as-randomized population (refers to the treatment regimen assigned at randomization).'}, {'type': 'SECONDARY', 'title': 'Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.4', 'ciLowerLimit': '-18.7', 'ciUpperLimit': '5.8', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.9', 'ciLowerLimit': '-29.9', 'ciUpperLimit': '-5.9', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participantsRandomized participants while on initial regimen (completers censored).'}, {'type': 'SECONDARY', 'title': 'Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96', 'description': 'Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants while on initial regimen (completers censored)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Cell Count at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'spread': '14.0', 'groupId': 'OG000'}, {'value': '59', 'spread': '11.8', 'groupId': 'OG001'}, {'value': '90', 'spread': '15.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Time-Averaged Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-18.4', 'ciLowerLimit': '-44.3', 'ciUpperLimit': '7.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Time-Averaged Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-44.9', 'ciLowerLimit': '-74.5', 'ciUpperLimit': '-15.3', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'cells/mm3', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participantsRandomized participants while on initial regimen (completers censored).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Cell Count at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'categories': [{'measurements': [{'value': '110', 'spread': '22.9', 'groupId': 'OG000'}, {'value': '72', 'spread': '19.7', 'groupId': 'OG001'}, {'value': '121', 'spread': '20.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Time-Averaged Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-17.5', 'ciLowerLimit': '-45.6', 'ciUpperLimit': '10.6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Time-Averaged Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-47.6', 'ciLowerLimit': '-79.2', 'ciUpperLimit': '-16.1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'unitOfMeasure': 'cells/mm3', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants while on initial regimen (completers censored).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Cell Count at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'categories': [{'measurements': [{'value': '122', 'spread': '26.3', 'groupId': 'OG000'}, {'value': '154', 'spread': '24.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 96', 'unitOfMeasure': 'cells/mm3', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants (while on initial regimen) with evaluation at time point'}, {'type': 'SECONDARY', 'title': 'Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline \\[log10 c/mL\\] Mean \\[SE\\] = -1.91 \\[0.19\\])'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline \\[log10 c/mL\\] Mean \\[SE\\] = -1.57 \\[0.3\\])'}], 'classes': [{'title': 'ATV Cmin', 'categories': [{'measurements': [{'value': '-0.056', 'groupId': 'OG000'}, {'value': '0.254', 'groupId': 'OG001'}]}]}, {'title': 'IQ (<10; >=10)', 'categories': [{'measurements': [{'value': '-0.391', 'groupId': 'OG000'}, {'value': '-0.081', 'groupId': 'OG001'}]}]}, {'title': '# of PI Mutations at baseline (<4; >=4)', 'categories': [{'measurements': [{'value': '0.306', 'groupId': 'OG000'}, {'value': '0.437', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P-value was based on a t-distribution.', 'groupDescription': 'Correlation between IQ (\\<10; \\>=10) of ATV 300 mg / RTV and HIV RNA', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value was based on a t-distribution.', 'groupDescription': 'Correlation between number of PI Mutations at baseline (\\<4; \\>=4) of ATV 400 mg / SQV and HIV RNA', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24', 'description': 'Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with HIV RNA change from baseline at Week 24 were explored.', 'unitOfMeasure': 'Pearson Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'Week 24: Participants with evaluable PK measurements'}, {'type': 'SECONDARY', 'title': 'Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline \\[log10 c/mL\\] Mean \\[SE\\] = -1.91 \\[0.19\\])'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline \\[log10 c/mL\\] Mean \\[SE\\] = -1.57 \\[0.3\\])'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 48', 'description': 'Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with HIV RNA change from baseline at Week 48 were explored.', 'unitOfMeasure': 'Pearson Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.'}, {'type': 'SECONDARY', 'title': 'Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (CD4 Cell Count Change from Baseline \\[cells/mm3\\] Mean \\[SE\\] = 80 \\[21\\])'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline \\[log10 c/mL\\] Mean \\[SE\\] = 56 \\[20\\])'}], 'classes': [{'title': 'ATV Cmin', 'categories': [{'measurements': [{'value': '0.37', 'groupId': 'OG000'}, {'value': '-0.21', 'groupId': 'OG001'}]}]}, {'title': 'IQ (<10; >=10)', 'categories': [{'measurements': [{'value': '0.376', 'groupId': 'OG000'}, {'value': '0.105', 'groupId': 'OG001'}]}]}, {'title': '# of PI Mutations at baseline (<4; >=4)', 'categories': [{'measurements': [{'value': '-0.395', 'groupId': 'OG000'}, {'value': '-0.227', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P-value was based on a t-distribution.', 'groupDescription': 'Correlation between ATV Cmin of ATV 300 mg / RTV and CD4 Cell Count', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P-value was based on a t-distribution.', 'groupDescription': 'Correlation between IQ (\\<10; \\>=10) of ATV 300 mg / RTV and CD4 Cell Count', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P-value was based on a t-distribution.', 'groupDescription': 'Correlation between # of PI Mutations at baseline (\\<4; \\>=4) of ATV 300 mg / RTV and CD4 Cell Count', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24', 'description': 'Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with CD4 cell count change from baseline at Week 24 were explored.', 'unitOfMeasure': 'Pearson Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with evaluable PK measurements, as-randomized population (refers to the treatment regimen assigned at randomization).'}, {'type': 'SECONDARY', 'title': 'Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (CD4 Cell Count Change from Baseline \\[cells/mm3\\] Mean \\[SE\\] = 80 \\[21\\])'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline \\[log10 c/mL\\] Mean \\[SE\\] = 56 \\[20\\])'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 48', 'description': 'Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with CD4 cell count change from baseline at Week 48 were explored.', 'unitOfMeasure': 'Pearson Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.'}, {'type': 'SECONDARY', 'title': 'Lipid Mean Percent Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'title': 'Total Cholesterol', 'categories': [{'measurements': [{'value': '-8', 'groupId': 'OG000'}, {'value': '-9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'High Density Lipoprotein (HDL) Cholesterol', 'categories': [{'measurements': [{'value': '-7', 'groupId': 'OG000'}, {'value': '-1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Fasting Low Density Lipoprotein (LDL) Cholesterol', 'categories': [{'measurements': [{'value': '-10', 'groupId': 'OG000'}, {'value': '-11', 'groupId': 'OG001'}, {'value': '-4', 'groupId': 'OG002'}]}]}, {'title': 'Fasting Triglycerides', 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000'}, {'value': '-14', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.9', 'ciLowerLimit': '-15.5', 'ciUpperLimit': '-6.0', 'groupDescription': 'Total Cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.4', 'ciLowerLimit': '-16.9', 'ciUpperLimit': '-7.6', 'groupDescription': 'Total Cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.7', 'ciLowerLimit': '-13.6', 'ciUpperLimit': '0.7', 'groupDescription': 'HDL cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-9.3', 'ciUpperLimit': '8.1', 'groupDescription': 'HDL Cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.8', 'ciLowerLimit': '-15.6', 'ciUpperLimit': '3.0', 'groupDescription': 'Fasting LDL Cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.3', 'ciLowerLimit': '-15.5', 'ciUpperLimit': '1.8', 'groupDescription': 'Fasting LDL Cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.9', 'ciLowerLimit': '-35.0', 'ciUpperLimit': '-13.2', 'groupDescription': 'Fasting Triglycerides', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-34.2', 'ciLowerLimit': '-43.4', 'ciUpperLimit': '-23.4', 'groupDescription': 'Fasting Triglycerides', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24', 'description': 'Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.', 'unitOfMeasure': 'percent change', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Participants, Last Observation Carried Forward (LOCF), as-randomized population (refers to the treatment regimen assigned at randomization).'}, {'type': 'SECONDARY', 'title': 'Lipid Mean Percent Change From Baseline at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'title': 'Total Cholesterol', 'categories': [{'measurements': [{'value': '-8', 'groupId': 'OG000'}, {'value': '-4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'HDL Cholesterol', 'categories': [{'measurements': [{'value': '-7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Fasting LDL Cholesterol', 'categories': [{'measurements': [{'value': '-10', 'groupId': 'OG000'}, {'value': '-3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Fasting Triglycerides', 'categories': [{'measurements': [{'value': '-4', 'groupId': 'OG000'}, {'value': '-14', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.1', 'ciLowerLimit': '-17.0', 'ciUpperLimit': '-7.2', 'groupDescription': 'Total Cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.0', 'ciLowerLimit': '-17.4', 'ciUpperLimit': '-6.5', 'groupDescription': 'Total Cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.4', 'ciLowerLimit': '-12.4', 'ciUpperLimit': '3.5', 'groupDescription': 'HDL Cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'DIfference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-11.0', 'ciUpperLimit': '9.3', 'groupDescription': 'HDL Cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.9', 'ciLowerLimit': '-19.0', 'ciUpperLimit': '1.2', 'groupDescription': 'Fasting LDL CHolesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.4', 'ciLowerLimit': '-17.7', 'ciUpperLimit': '3.0', 'groupDescription': 'Fasting LDL Cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-29.6', 'ciLowerLimit': '-41.6', 'ciUpperLimit': '-17.7', 'groupDescription': 'Fasting Triglycerides', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-38.4', 'ciLowerLimit': '-49.7', 'ciUpperLimit': '-27.1', 'groupDescription': 'Fasting Triglycerides', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.', 'unitOfMeasure': 'percent change in lipid values', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Participants, Last Observation Carried Forward (LOCF); as-randomized population (refers to the treatment regimen assigned at randomization).'}, {'type': 'SECONDARY', 'title': 'Lipid Mean Percent Change From Baseline at Week 96, Observed Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'title': 'Total Cholesterol (n=60, 46, 54)', 'categories': [{'measurements': [{'value': '-7', 'groupId': 'OG000'}, {'value': '-1', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'HDL Cholesterol (n=60, 46, 54)', 'categories': [{'measurements': [{'value': '-5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Fasting LDL Cholesterol (n=52, 39, 43)', 'categories': [{'measurements': [{'value': '-11', 'groupId': 'OG000'}, {'value': '-7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Fasting Triglycerides (n=52, 40, 43)', 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.4', 'ciLowerLimit': '-20.1', 'ciUpperLimit': '-8.3', 'estimateComment': 'ATV 300/RTV - LPV/RTV', 'groupDescription': 'Observed values, Total Cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.0', 'ciLowerLimit': '-16.1', 'ciUpperLimit': '-1.3', 'estimateComment': 'ATV 400/SQV - LPV/RTV', 'groupDescription': 'observed values, total cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.0', 'ciLowerLimit': '-19.9', 'ciUpperLimit': '-1.2', 'estimateComment': 'ATV 300/RTV - LPV/RTV', 'groupDescription': 'observed values, HDL cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.1', 'ciLowerLimit': '-14.0', 'ciUpperLimit': '7.0', 'estimateComment': 'ATV 400/SQV - LPV/RTV', 'groupDescription': 'Observed values, HDL cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.7', 'ciLowerLimit': '-22.3', 'ciUpperLimit': '-1.8', 'estimateComment': 'ATV 300/RTV - LPV/RTV', 'groupDescription': 'observed cases, fasting LDL', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.9', 'ciLowerLimit': '-19.0', 'ciUpperLimit': '4.8', 'estimateComment': 'ATV 400/SQV - LPV/RTV', 'groupDescription': 'Observed Cases, Fasting LDL cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.8', 'ciLowerLimit': '-38.6', 'ciUpperLimit': '-8.0', 'estimateComment': 'ATV 300/RTV - LPV/RTV', 'groupDescription': 'observed cases, fasting triglycerides', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.8', 'ciLowerLimit': '-36.5', 'ciUpperLimit': '1.3', 'estimateComment': 'ATV 400/SQV - LPV/RTV', 'groupDescription': 'observed cases, fasting triglycerides', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96', 'description': 'Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.', 'unitOfMeasure': 'percent change in lipid values', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Participants; as-randomized population (refers to the treatment regimen assigned at randomization).'}, {'type': 'SECONDARY', 'title': 'Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'title': 'Deaths (n = 120, 115, 123)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'AEs leading to discontinuation (n = 119, 110, 118)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'SAEs (n = 120, 115, 123)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'AEs, grades 1-4 (n = 119, 110, 118)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}]}]}, {'title': 'AEs, grades 3-4 (n = 119, 110, 118)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Enrollment through Week 48', 'description': 'AE=any new untoward medical occurrence/worsening of a pre-existing medical condition regardless of causal relationship. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires/prolongs inpatient hospitalization; results in persistent/significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants for Deaths and SAEs; treated participants for all others; as-randomized population (refers to the treatment regimen assigned at randomization). In addition, of the 213 screen failures (not randomized), there were 4 subjects who had an SAE; these are not included in the table below.'}, {'type': 'SECONDARY', 'title': 'Most Common AEs and AEs of Interest Through Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'title': 'Diarrhea (Most Common)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}]}, {'title': 'Headache (Most Common)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Nausea (Most Common)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Jaundice (AE of Interest)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Ocular Icterus (AE of Interest)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperbilirubinemia (AE of Interest)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Enrollment to Week 48', 'description': 'Prespecified AEs of interest included jaundice, ocular icterus, and hyperbilirubinemia.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization).'}, {'type': 'SECONDARY', 'title': 'Fasting Glucose Mean Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-3', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '0', 'spread': '1.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Participants with evaluation at time point; as-randomized population (refers to the treatment regimen assigned at randomization).'}, {'type': 'SECONDARY', 'title': 'Fasting Glucose Mean Change From Baseline at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '-1', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '1', 'spread': '1.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 48', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Participants with evaluation at time point; as-randomized population (refers to the treatment regimen assigned at randomization).'}, {'type': 'SECONDARY', 'title': 'Grade 3/4 Laboratory Abnormalities Through Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'title': 'Neutrophil Reduction', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Platelet Reduction', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'ALT Elevation', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'AST Elevation', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Total Bilirubin Elevation', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Enrollment to Week 48', 'description': 'Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. Abnormal values: absolute neutrophil count: ≥500 to \\<750/mm3 (grade 3), \\<500/mm3 (grade 4); platelets: 20,000-49,999/mm3 (grade 3), \\<20,000/mm3 or diffuse petechiae (grade 4); alanine transaminase (ALT): 5.1-10 x upper limit of normal (ULN; grade 3), \\>10 x ULN (grade 4); aspartate transaminase (AST): 5.1-10 x ULN (grade 3), \\>10 x ULN (grade 4); bilirubin: 2.6-5 x ULN (grade 3), \\>5 x ULN (grade 4).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable treated participants; as-randomized population (refers to the treatment regimen assigned at randomization).'}, {'type': 'SECONDARY', 'title': 'Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'title': 'Baseline Mean (n=119, 110, 118)', 'categories': [{'measurements': [{'value': '390', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '387', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '390', 'spread': '1.9', 'groupId': 'OG002'}]}]}, {'title': 'Mean Change at Week 4 predose (n=117, 104, 110)', 'categories': [{'measurements': [{'value': '-3', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '1', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '-2', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': 'Mean Change Wk 4 2-3 hrs postdose (n=113,102,106)', 'categories': [{'measurements': [{'value': '-2', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-3', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '-7', 'spread': '1.9', 'groupId': 'OG002'}]}]}, {'title': 'Mean Change Wk 4 6-12 hrs postdose (n=112,101,105)', 'categories': [{'measurements': [{'value': '-4', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-1', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '-8', 'spread': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Mean Change at Week 12 (n=110, 97, 107)', 'categories': [{'measurements': [{'value': '2', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '3', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '2', 'spread': '1.6', 'groupId': 'OG002'}]}]}, {'title': 'Mean Change at Week 24 (n=108, 92, 109)', 'categories': [{'measurements': [{'value': '1', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '3', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '2', 'spread': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Mean Change at Week 48 (n=89, 75, 97)', 'categories': [{'measurements': [{'value': '-1', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '-1', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '0', 'spread': '2.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48', 'description': "The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QT interval was corrected for heart rate using Fridericia's (QTcF) formula.", 'unitOfMeasure': 'msec', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated at timepoint'}, {'type': 'SECONDARY', 'title': 'PR Interval and Change From Baseline by Analysis Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'title': 'Baseline Mean (n=119, 110, 118)', 'categories': [{'measurements': [{'value': '153', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '155', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '154', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': 'Mean Change at Week 4 predose (n=117, 104, 110)', 'categories': [{'measurements': [{'value': '4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '9', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '3', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Mean Change Wk 4 2-3 hrs postdose (n=113,102,106)', 'categories': [{'measurements': [{'value': '1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '6', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '1', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': 'Mean Change Wk 4 6-12 hrs postdose (n=112,101,105)', 'categories': [{'measurements': [{'value': '2', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '6', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '2', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Mean Change at Week 12 (n=110, 97, 107)', 'categories': [{'measurements': [{'value': '5', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '7', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '8', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Mean Change at Week 24 (n=108, 92, 109)', 'categories': [{'measurements': [{'value': '2', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '7', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '5', 'spread': '1.6', 'groupId': 'OG002'}]}]}, {'title': 'Mean Change at Week 48 (n=89, 75, 97)', 'categories': [{'measurements': [{'value': '0', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '2', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '4', 'spread': '1.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48', 'description': 'The PR interval is measured from the beginning of the P wave to the beginning of the QRS complex, and reflects the time the electrical impulse takes to travel from the sinus node through the atrioventricular (AV) node and entering the ventricles. The PR interval is therefore a good estimate of AV node function.', 'unitOfMeasure': 'msec', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated at timepoint'}, {'type': 'SECONDARY', 'title': 'Adherence to Regimen Though Week 48 Based on MACS the Multicenter AIDS Cohort Study (MACS) Adherence Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'title': 'Adherent at Baseline (n=27, 25, 33)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Adherent at Week 24 (n=18, 11, 25)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Adherent at Week 48 (n=11, 4, 20)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24, Week 48', 'description': 'The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Drug-specific questions included adherence with dose and frequency. Adherence was defined as taking all doses and numbers of pills as prescribed for each medication. This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Participants Analyzed=treated participants; as-randomized population (refers to the treatment regimen assigned at randomization); n=subset of treated participants (Given the language limitation, a subset of the AI424045 population was included in the MACS adherence analysis.)'}, {'type': 'SECONDARY', 'title': 'Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Health Index Score at Baseline, Mid-Study (Week 24), and Final (Week 48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'title': 'Baseline (n=99, 86, 100)', 'categories': [{'measurements': [{'value': '0.83', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '0.02', 'groupId': 'OG001'}, {'value': '0.86', 'spread': '0.02', 'groupId': 'OG002'}]}]}, {'title': 'Mid-Study (n=103, 83, 95)', 'categories': [{'measurements': [{'value': '0.87', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.86', 'spread': '0.02', 'groupId': 'OG001'}, {'value': '0.89', 'spread': '0.01', 'groupId': 'OG002'}]}]}, {'title': 'Final (n=93, 84, 96)', 'categories': [{'measurements': [{'value': '0.84', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '0.88', 'spread': '0.02', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24, Week 48', 'description': 'The EQ-5D is a 5-item questionnaire to assess health-related quality of life in 5 health dimensions (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) are scored on a 3-level scale: no problems (1), some problems (2), extreme problems (3). Using a standard algorithm, responses are summarized into a single score, the EQ-5D Health Index Score (HIS), which ranges between 1 (representing perfect health) and 0 (representing the worst imaginable health state or death). The smallest coefficient of change is 0.03.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated with EQ-5D at given time point.'}, {'type': 'SECONDARY', 'title': 'Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Baseline, Mid-Study (Week 24), and Final (Week 48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'title': 'Baseline (n=98, 85, 101)', 'categories': [{'measurements': [{'value': '81.33', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '81.72', 'spread': '1.77', 'groupId': 'OG001'}, {'value': '81.52', 'spread': '1.53', 'groupId': 'OG002'}]}]}, {'title': 'Mid-Study (n=102, 83, 97)', 'categories': [{'measurements': [{'value': '84.89', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '83.34', 'spread': '1.89', 'groupId': 'OG001'}, {'value': '85.09', 'spread': '1.55', 'groupId': 'OG002'}]}]}, {'title': 'Final (n=95, 81, 96)', 'categories': [{'measurements': [{'value': '82.77', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '85.80', 'spread': '1.64', 'groupId': 'OG001'}, {'value': '86.16', 'spread': '1.36', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24, Week 48', 'description': 'The EQ-5D has a Visual Analog Scale (VAS), which is a feeling thermometer-like scale with a range between 0 and 100. Patients are required to draw a line from a box on the VAS scale to an actual mark on the thermometer-like scale that corresponds with a number that reflects their self-assessed health status at the time they are completing the questionnaire. Higher VAS scores indicate better overall health. There is no minimum clinically important difference reported in the literature for VAS.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated with EQ-5D at given time point.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in HIV RNA at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.29', 'spread': '0.121', 'groupId': 'OG000'}, {'value': '-2.08', 'spread': '0.151', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'time-averaged difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.14', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.41', 'estimateComment': 'ATV 300/RTV - LPV/RTV', 'groupDescription': 'overall', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'time-averaged difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.11', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.38', 'estimateComment': 'ATV 300/RTV - LPV/RTV', 'groupDescription': 'last observation carried forward', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 96', 'unitOfMeasure': 'log10 c/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants while on initial regimen'}, {'type': 'SECONDARY', 'title': 'Number of Participants Utilizing Resources for Managing Lipid Elevation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24, Week 48', 'description': "Participants' overall resource utilization for managing lipid elevation that includes the management of side effects of lipid lowering medications, such as those due to drug interactions.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Although the intent of this planned analysis was to provide a model of economic value for Lipid Management, a different approach was taken to create this model which did not require data from this trial, and thus this analysis was not done.'}, {'type': 'SECONDARY', 'title': 'Mean ATV, RTV and SQV Minimum Concentration (Cmin) Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'title': 'ATV (n=40,23)', 'categories': [{'measurements': [{'value': '719.53', 'spread': '82.81', 'groupId': 'OG000'}, {'value': '312.01', 'spread': '145.31', 'groupId': 'OG001'}]}]}, {'title': 'RTV (n=40,0)', 'categories': [{'measurements': [{'value': '154.83', 'spread': '39.31', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No participants were analyzed in this cohort for RTV because they did not take this drug.', 'groupId': 'OG001'}]}]}, {'title': 'SQV (n=0,19)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participants were analyzed in this cohort for SQV because they did not take this drug.', 'groupId': 'OG000'}, {'value': '52.15', 'spread': '16.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'collected at the pre-dose time point after receiving atazanavir for at least four weeks', 'description': 'The minimum or "trough" concentration (Cmin) of a drug observed after its administration and just prior to the administration of a subsequent dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with evaluable Cmins; as-randomized population (refers to the treatment regimen assigned at randomization).'}, {'type': 'SECONDARY', 'title': 'HIV IC50 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'categories': [{'measurements': [{'value': '17.83', 'spread': '4.04', 'groupId': 'OG000'}, {'value': '22.84', 'spread': '11.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'IC50: inhibitory concentration of drug required to reduce viral replication by 50%.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with evaluable IC50 measurements; as-randomized population (refers to the treatment regimen assigned at randomization).'}, {'type': 'SECONDARY', 'title': 'Inhibitory Quotient at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'categories': [{'measurements': [{'value': '136.94', 'spread': '24.33', 'groupId': 'OG000'}, {'value': '25.04', 'spread': '13.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Inhibitory quotient is a measure of drug exposure and susceptibility in an individual. The IQ is typically calculated as the ratio of Cmin to HIV IC50.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with evaluable IQ measurements (ie, must have both Cmin and IC50 measurements); as-randomized population (refers to the treatment regimen assigned at randomization).'}, {'type': 'SECONDARY', 'title': 'Inhibitory Quotient at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'Inhibitory quotient is a measure of drug exposure and susceptibility in an individual. The IQ is typically calculated as the ratio of Cmin to HIV IC50.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.'}, {'type': 'SECONDARY', 'title': 'HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'classes': [{'title': 'Baseline Values', 'categories': [{'measurements': [{'value': '4.53', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '4.41', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 Values', 'categories': [{'measurements': [{'value': '2.62', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '2.83', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 24', 'categories': [{'measurements': [{'value': '-1.91', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-1.57', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Week 24 HIV RNA level and change from baseline were summarized for treated subjects with evaluable Cmins.', 'unitOfMeasure': 'log10 c/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with evaluable Cmins; as-randomized population (refers to the treatment regimen assigned at randomization).'}, {'type': 'SECONDARY', 'title': 'HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'OG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'Week 24 HIV RNA level and change from baseline were summarized for treated subjects with evaluable Cmins.', 'unitOfMeasure': 'log10 c/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ATV 300 mg / RTV', 'description': 'atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg + tenofovir (TDF) 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'FG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + saquinavir (SQV) 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'FG002', 'title': 'LPV / RTV', 'description': 'lopinavir (LPV)/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '120 randomized, 119 treated', 'groupId': 'FG000', 'numSubjects': '119'}, {'comment': '115 randomized, 110 treated', 'groupId': 'FG001', 'numSubjects': '110'}, {'comment': '123 randomized, 118 treated', 'groupId': 'FG002', 'numSubjects': '118'}]}, {'type': 'Discontinued Prior to Week 48 Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Discontinued Between Weeks 48 and 96', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'Discontinued on or After Week 96', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '63 remained on treatment, 0 completed at Week 96', 'groupId': 'FG000', 'numSubjects': '63'}, {'comment': '50 remained on treatment, 0 completed at Week 96', 'groupId': 'FG001', 'numSubjects': '50'}, {'comment': '59 remained on treatment, 10 completed at Week 96', 'groupId': 'FG002', 'numSubjects': '69'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '49'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Disease Progression / Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Protocol Violation While on Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Study Termination by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '28'}]}]}], 'preAssignmentDetails': '571 human immunodeficiency virus (HIV)-infected participants were enrolled; 358 (63%) were randomized to treatment. Of the 213 not randomized, 194 did not meet eligibility criteria; other reasons include duplicate enrollment (4), accrual closed (1), noncompliance (1), serious adverse event (2), patient request (11), missing information (4).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}, {'value': '358', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'ATV 300 mg / RTV', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'BG001', 'title': 'ATV 400 mg / SQV', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'BG002', 'title': 'LPV / RTV', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '71'}, {'value': '41', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '74'}, {'value': '39', 'groupId': 'BG002', 'lowerLimit': '25', 'upperLimit': '72'}, {'value': '40', 'groupId': 'BG003', 'lowerLimit': '24', 'upperLimit': '74'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '281', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '216', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South America', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '165', 'groupId': 'BG003'}]}]}, {'title': 'North America', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}]}]}, {'title': 'Europe', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Acquired Immunodeficiency Virus (AIDS)', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '256', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Intravenous (IV) Drug Use', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '335', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cluster of Differentiation 4 (CD4) cell count', 'classes': [{'categories': [{'measurements': [{'value': '317', 'groupId': 'BG000', 'lowerLimit': '40', 'upperLimit': '1025'}, {'value': '286', 'groupId': 'BG001', 'lowerLimit': '42', 'upperLimit': '1543'}, {'value': '283', 'groupId': 'BG002', 'lowerLimit': '14', 'upperLimit': '1238'}, {'value': '297', 'groupId': 'BG003', 'lowerLimit': '14', 'upperLimit': '1543'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'FULL_RANGE'}, {'title': 'Human Immunodeficiency Virus Ribonucleic Acid (HIV RNA)', 'classes': [{'categories': [{'measurements': [{'value': '4.44', 'groupId': 'BG000', 'lowerLimit': '2.60', 'upperLimit': '5.88'}, {'value': '4.42', 'groupId': 'BG001', 'lowerLimit': '2.60', 'upperLimit': '5.88'}, {'value': '4.47', 'groupId': 'BG002', 'lowerLimit': '2.60', 'upperLimit': '5.88'}, {'value': '4.45', 'groupId': 'BG003', 'lowerLimit': '2.60', 'upperLimit': '5.88'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'log10 c/mL', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 571}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-11'}, 'expandedAccessInfo': {'hasExpandedAccess': True}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-29', 'studyFirstSubmitDate': '2002-05-06', 'resultsFirstSubmitDate': '2010-10-14', 'studyFirstSubmitQcDate': '2002-05-07', 'lastUpdatePostDateStruct': {'date': '2010-12-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-11-29', 'studyFirstPostDateStruct': {'date': '2002-05-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Mean Change From Baseline in HIV RNA at Week 48', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Mean Change From Baseline in HIV RNA at Week 96', 'timeFrame': 'Baseline, Week 96'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in HIV RNA at Week 2', 'timeFrame': 'Baseline, Week 2'}, {'measure': 'Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity)', 'timeFrame': 'Baseline, Week 24', 'description': 'Number of participants with a \\>=0.5 log10 decrease in HIV RNA from baseline or HIV RNA \\< 400 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI.'}, {'measure': 'Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity)', 'timeFrame': 'Baseline, Week 48', 'description': 'Number of participants with a \\>=0.5 log10 decrease in HIV RNA from baseline or HIV RNA \\< 400 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI.'}, {'measure': 'Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96', 'timeFrame': 'Baseline, Week 96', 'description': 'Number of participants with a \\>=0.5 log10 decrease in HIV RNA from baseline or HIV RNA \\< 400 c/mL at Week 96.'}, {'measure': 'Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24', 'timeFrame': 'Week 24'}, {'measure': 'Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24, by PI Sensitivity', 'timeFrame': 'Baseline, Week 24', 'description': 'Number of participants with a \\>=0.5 log10 decrease in HIV RNA from baseline or HIV RNA \\< 50 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI.'}, {'measure': 'Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48', 'timeFrame': 'Week 48'}, {'measure': 'Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48, by PI Sensitivity', 'timeFrame': 'Baseline, Week 48', 'description': 'Number of participants with a \\>=0.5 log10 decrease in HIV RNA from baseline or HIV RNA \\< 50 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI.'}, {'measure': 'Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 96', 'timeFrame': 'Week 96'}, {'measure': 'Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 24', 'timeFrame': 'Week 24', 'description': 'Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.'}, {'measure': 'Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 48', 'timeFrame': 'Week 48', 'description': 'Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.'}, {'measure': 'Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 96', 'timeFrame': 'Week 96', 'description': 'Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.'}, {'measure': 'Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 24', 'timeFrame': 'Week 24', 'description': 'Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.'}, {'measure': 'Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 48', 'timeFrame': 'Week 48', 'description': 'Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.'}, {'measure': 'Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 96', 'timeFrame': 'Week 96', 'description': 'Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.'}, {'measure': 'Change From Baseline in CD4 Cell Count at Week 24', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change From Baseline in CD4 Cell Count at Week 48', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Change From Baseline in CD4 Cell Count at Week 96', 'timeFrame': 'Baseline, Week 96'}, {'measure': 'Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with HIV RNA change from baseline at Week 24 were explored.'}, {'measure': 'Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 48', 'timeFrame': 'Baseline, Week 48', 'description': 'Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with HIV RNA change from baseline at Week 48 were explored.'}, {'measure': 'Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with CD4 cell count change from baseline at Week 24 were explored.'}, {'measure': 'Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 48', 'timeFrame': 'Baseline, Week 48', 'description': 'Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with CD4 cell count change from baseline at Week 48 were explored.'}, {'measure': 'Lipid Mean Percent Change From Baseline at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.'}, {'measure': 'Lipid Mean Percent Change From Baseline at Week 48', 'timeFrame': 'Week 48', 'description': 'Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.'}, {'measure': 'Lipid Mean Percent Change From Baseline at Week 96, Observed Values', 'timeFrame': 'Week 96', 'description': 'Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.'}, {'measure': 'Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48', 'timeFrame': 'From Enrollment through Week 48', 'description': 'AE=any new untoward medical occurrence/worsening of a pre-existing medical condition regardless of causal relationship. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires/prolongs inpatient hospitalization; results in persistent/significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event.'}, {'measure': 'Most Common AEs and AEs of Interest Through Week 48', 'timeFrame': 'From Enrollment to Week 48', 'description': 'Prespecified AEs of interest included jaundice, ocular icterus, and hyperbilirubinemia.'}, {'measure': 'Fasting Glucose Mean Change From Baseline at Week 24', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Fasting Glucose Mean Change From Baseline at Week 48', 'timeFrame': 'Week 48'}, {'measure': 'Grade 3/4 Laboratory Abnormalities Through Week 48', 'timeFrame': 'From Enrollment to Week 48', 'description': 'Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. Abnormal values: absolute neutrophil count: ≥500 to \\<750/mm3 (grade 3), \\<500/mm3 (grade 4); platelets: 20,000-49,999/mm3 (grade 3), \\<20,000/mm3 or diffuse petechiae (grade 4); alanine transaminase (ALT): 5.1-10 x upper limit of normal (ULN; grade 3), \\>10 x ULN (grade 4); aspartate transaminase (AST): 5.1-10 x ULN (grade 3), \\>10 x ULN (grade 4); bilirubin: 2.6-5 x ULN (grade 3), \\>5 x ULN (grade 4).'}, {'measure': 'Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point', 'timeFrame': 'Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48', 'description': "The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QT interval was corrected for heart rate using Fridericia's (QTcF) formula."}, {'measure': 'PR Interval and Change From Baseline by Analysis Time Point', 'timeFrame': 'Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48', 'description': 'The PR interval is measured from the beginning of the P wave to the beginning of the QRS complex, and reflects the time the electrical impulse takes to travel from the sinus node through the atrioventricular (AV) node and entering the ventricles. The PR interval is therefore a good estimate of AV node function.'}, {'measure': 'Adherence to Regimen Though Week 48 Based on MACS the Multicenter AIDS Cohort Study (MACS) Adherence Questionnaire', 'timeFrame': 'Baseline, Week 24, Week 48', 'description': 'The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Drug-specific questions included adherence with dose and frequency. Adherence was defined as taking all doses and numbers of pills as prescribed for each medication. This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance.'}, {'measure': 'Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Health Index Score at Baseline, Mid-Study (Week 24), and Final (Week 48)', 'timeFrame': 'Baseline, Week 24, Week 48', 'description': 'The EQ-5D is a 5-item questionnaire to assess health-related quality of life in 5 health dimensions (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) are scored on a 3-level scale: no problems (1), some problems (2), extreme problems (3). Using a standard algorithm, responses are summarized into a single score, the EQ-5D Health Index Score (HIS), which ranges between 1 (representing perfect health) and 0 (representing the worst imaginable health state or death). The smallest coefficient of change is 0.03.'}, {'measure': 'Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Baseline, Mid-Study (Week 24), and Final (Week 48)', 'timeFrame': 'Baseline, Week 24, Week 48', 'description': 'The EQ-5D has a Visual Analog Scale (VAS), which is a feeling thermometer-like scale with a range between 0 and 100. Patients are required to draw a line from a box on the VAS scale to an actual mark on the thermometer-like scale that corresponds with a number that reflects their self-assessed health status at the time they are completing the questionnaire. Higher VAS scores indicate better overall health. There is no minimum clinically important difference reported in the literature for VAS.'}, {'measure': 'Number of Participants Utilizing Resources for Managing Lipid Elevation', 'timeFrame': 'Baseline, Week 24, Week 48', 'description': "Participants' overall resource utilization for managing lipid elevation that includes the management of side effects of lipid lowering medications, such as those due to drug interactions."}, {'measure': 'Mean ATV, RTV and SQV Minimum Concentration (Cmin) Values', 'timeFrame': 'collected at the pre-dose time point after receiving atazanavir for at least four weeks', 'description': 'The minimum or "trough" concentration (Cmin) of a drug observed after its administration and just prior to the administration of a subsequent dose.'}, {'measure': 'HIV IC50 at Week 24', 'timeFrame': 'Week 24', 'description': 'IC50: inhibitory concentration of drug required to reduce viral replication by 50%.'}, {'measure': 'Inhibitory Quotient at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Inhibitory quotient is a measure of drug exposure and susceptibility in an individual. The IQ is typically calculated as the ratio of Cmin to HIV IC50.'}, {'measure': 'Inhibitory Quotient at Week 48', 'timeFrame': 'Baseline, Week 48', 'description': 'Inhibitory quotient is a measure of drug exposure and susceptibility in an individual. The IQ is typically calculated as the ratio of Cmin to HIV IC50.'}, {'measure': 'HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Week 24 HIV RNA level and change from baseline were summarized for treated subjects with evaluable Cmins.'}, {'measure': 'HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 48', 'timeFrame': 'Baseline, Week 48', 'description': 'Week 24 HIV RNA level and change from baseline were summarized for treated subjects with evaluable Cmins.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn how well atazanavir (ATV) works in combination with ritonavir (RTV) or saquinavir (SQV) with tenofovir (TDF) and a nucleoside to reduce the viral load of treatment experienced subjects with human immunodeficiency virus (HIV). There is a comparison arm with lopinavir (LPV)/RTV and TDF and a nucleoside.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Virologic failure to 2 or more highly active antiretroviral therapy (HAART) regimens that, in total, have included at least one drug from all approved classes protease inhibitors, non-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors (PI, NNRTI, NRTI):\n\n 1. Currently on a failing HAART regimen with 2 qualifying plasma viral load measurements (hospital/clinic value within 4 weeks of screening with viral load equivalent to =\\>1,000 c/mL on the Roche Amplicor\\[TM\\] and central lab measurements of =\\>1,000 c/mL (Roche Amplicor\\[TM\\]) within 4 weeks of randomization\n 2. Cluster of Differentiation 4 (CD4) cell count =\\>50 cells/mm3 obtained within 4 weeks prior to randomization\n* =\\>16 years of age (or minimum age as determined by local regulations or as legal requirements dictate);\n* History of prior virologic response to at least one HAART regimen, defined as a 1.0 log10 decline or a decline in viral load to \\<400 c/mL by Roche Amplicor or \\<500 c/mL by Chiron Quantiplex branched DNA (bDNA) assay\n* Both females of child bearing potential and males must utilize effective barrier contraception to reduce transmission of sexually transmitted disease, including human immunodeficiency virus (HIV). Other contraception in addition to barrier methods is permitted; interaction between atazanavir and oral contraceptives has not been studied.\n* Subjects must be able to provide written informed consent;\n* Subjects should be available for follow-up for a period of at least 48 weeks\n* Baseline laboratory values measured within 2 weeks prior to initiating study drugs as follows:\n\n 1. serum creatine \\<1.5 times the upper limit of normal (ULN)\n 2. total serum lipase \\<1.4 times the ULN\n 3. liver enzymes alanine aminotransferase (AST), aspartate aminotransferase (ALT) \\<3 times the ULN\n 4. total serum bilirubin \\<1.5 times the ULN\n\nExclusion Criteria:\n\n* Prior use (=\\>3 days) of atazanavir, TVF or LPV/RTV; if history of SQV, then must be phenotypically sensitive\n* the current failing antiretroviral regimen must have been administered for at least eight weeks at he initiation of screening and must not include both a PI and NNRTI\n* Presence of a newly diagnosed HIV-related opportunistic infection or any medical requiring acute therapy at the time of enrollment\n* Proven or suspected acute hepatitis in the 30 days prior to study entry. Subjects with chronic hepatitis are eligible provided that their liver function enzymes (ALT/AST) are \\<3 x ULN\n* Previous therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatoxic, hepatoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment of therapy with methadone or ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect Cytochrome P450 3A4 (CYP3A4).\n* Active alcohol or substance use sufficient, in the Investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis\n* Intractable diarrhea (=\\> 6 loose stools/day for at least 7 days consecutive days) within 30 days prior to study entry\n* Pregnancy or breast-feeding\n* History of hemophilia\n* Presence of cardiomyopathy\n* Any one of the following:\n\n 1. Heart rate-corrected QT (QTc) interval \\>450 msec on the screening electrocardiogram (EKG)\n 2. Heart rate \\<40 beats per minute (bpm)\n 3. Pause length \\>3 seconds seen on EKG\n 4. Clinical symptoms potentially related to heart block\n 5. Third degree heart block\n* History of acute or chronic pancreatitis\n* If choosing 2'-3' dideoxyinosine (ddI) or 2',3'-didehydro-3'-deoxythymidine (d4T) as the NRTI: History or signs and symptoms of bilateral peripheral neuropathy =\\> Grade 2 at the time of screening\n* Inability to tolerate oral medications\n* Any other clinical conditions or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for study or unable to comply with the dosing requirements."}, 'identificationModule': {'nctId': 'NCT00035932', 'briefTitle': 'Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV', 'nctIdAliases': ['NCT00028054'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Phase III Open Label Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV', 'orgStudyIdInfo': {'id': 'AI424-045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'I', 'description': 'ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice\n\nATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study', 'interventionNames': ['Drug: Atazanavir + ritonavir + tenofovir + nucleoside']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'II', 'description': 'ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice\n\nATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study', 'interventionNames': ['Drug: Atazanavir + saquinavir + tenofovir + nucleoside']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'III', 'description': 'LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice\n\nLPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study', 'interventionNames': ['Drug: Lopinavir/ritonavir + tenofovir + nucleoside']}], 'interventions': [{'name': 'Atazanavir + ritonavir + tenofovir + nucleoside', 'type': 'DRUG', 'otherNames': ['BMS-232632', 'Reyataz'], 'description': 'Active Comparator, Capsules, tablets, Oral', 'armGroupLabels': ['I']}, {'name': 'Atazanavir + saquinavir + tenofovir + nucleoside', 'type': 'DRUG', 'otherNames': ['BMS-232632', 'Reyataz'], 'description': 'Active Comparator, Capsules, tablets, Oral', 'armGroupLabels': ['II']}, {'name': 'Lopinavir/ritonavir + tenofovir + nucleoside', 'type': 'DRUG', 'description': 'Active Comparator, Capsules, tablets, Oral', 'armGroupLabels': ['III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80304', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'city': 'Altamonte Springs', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.66111, 'lon': -81.36562}}, {'zip': '33306', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33160', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '96816', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'city': 'Boise', 'state': 'Indiana', 'country': 'United States'}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Brookline', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.33176, 'lon': -71.12116}}, {'zip': '02720', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'city': 'East Orange', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.76732, 'lon': -74.20487}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '29203', '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}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77006', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Bristol-Myers Squibb'}}}}