Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT01495702
Status:
COMPLETED
Last Update Posted:
2016-01-07
First Post:
2011-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'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': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}, {'id': 'D000069545', 'term': 'Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}], 'ancestors': [{'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000069547', 'term': 'Cobicistat'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosures@gilead.com', 'title': 'Clinical Trial Disclosures', 'organization': 'Gilead Sciences, Inc.'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'There were no limitations affecting the analysis or results.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline through end of study (average 90 weeks)', 'description': 'Safety Analysis Set participants were randomized and received at least 1 dose of study drug', 'eventGroups': [{'id': 'EG000', 'title': 'Stribild (Randomized Phase)', 'description': 'Adverse events for this reporting group include those occurring in participants receiving Stribild in the randomized phase.\n\nParticipants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.', 'otherNumAtRisk': 291, 'otherNumAffected': 154, 'seriousNumAtRisk': 291, 'seriousNumAffected': 24}, {'id': 'EG001', 'title': 'NNRTI+FTC/TDF (Randomized Phase)', 'description': 'Adverse events for this reporting group include those occurring in participants receiving NNRTI+FTC/TDF in the randomized phase.\n\nParticipants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.', 'otherNumAtRisk': 143, 'otherNumAffected': 66, 'seriousNumAtRisk': 143, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'All Stribild', 'description': 'Adverse events for this reporting group include those occurring in all participants while receiving Stribild in the randomized and extension phases.', 'otherNumAtRisk': 293, 'otherNumAffected': 154, 'seriousNumAtRisk': 293, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Syphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 22}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Shigella infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Psychomotor hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Delusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Drug abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Substance-induced psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stribild', 'description': 'Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.'}, {'id': 'OG001', 'title': 'NNRTI+FTC/TDF', 'description': 'Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.4', 'groupId': 'OG000'}, {'value': '88.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.066', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.3', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '12.0', 'estimateComment': 'The 95% confidence interval (CI) for the difference was from unconditional exact method using 2 inverted 1-sided tests with the standardized statistic using StatXact.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The null hypothesis was that the Stribild group was at least 12% worse than the NNRTI+FTC/TDF group with respect to the percentage of participants maintaining HIV-1 RNA \\< 50 copies/mL at Week 48. The alternative hypothesis was that the Stribild group was less than 12% worse than the NNRTI+FTC/TDF group.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': "The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: participants were randomized, received at least 1 dose of study drug, had no documented resistance, and were on an NNRTI at screening'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stribild', 'description': 'Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.'}, {'id': 'OG001', 'title': 'NNRTI+FTC/TDF', 'description': 'Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.6', 'groupId': 'OG000'}, {'value': '80.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96', 'description': "The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ Cell Count at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stribild', 'description': 'Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.'}, {'id': 'OG001', 'title': 'NNRTI+FTC/TDF', 'description': 'Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'spread': '147.3', 'groupId': 'OG000'}, {'value': '58', 'spread': '179.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 48', 'unitOfMeasure': 'cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ Cell Count at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stribild', 'description': 'Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.'}, {'id': 'OG001', 'title': 'NNRTI+FTC/TDF', 'description': 'Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'spread': '166.7', 'groupId': 'OG000'}, {'value': '101', 'spread': '156.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 96', 'unitOfMeasure': 'cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data while on study drug were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stribild', 'description': 'Participants switched from their baseline treatment regimen to Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.'}, {'id': 'FG001', 'title': 'NNRTI+FTC/TDF', 'description': 'Participants stayed on their baseline treatment regimen consisting of an nonnucleoside reverse transcriptase inhibitor (NNRTI) (efavirenz (EFV), nevirapine (NVP), or rilpivirine (RPV)) plus emtricitabine (FTC)/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.'}], 'periods': [{'title': 'Randomized Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '292'}, {'groupId': 'FG001', 'numSubjects': '147'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '266'}, {'groupId': 'FG001', 'numSubjects': '119'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Randomized But Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Investigators Discretion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Participant Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Extension Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in North America, Europe, and Australia. The first participant was screened on 13 December 2011. The last study visit occurred on 01 December 2014.', 'preAssignmentDetails': '571 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '434', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Stribild', 'description': 'Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.'}, {'id': 'BG001', 'title': 'NNRTI+FTC/TDF', 'description': 'Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '40', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '41', 'spread': '9.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 40 years', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}]}, {'title': '≥ 40 to < 50 years', 'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}, {'title': '≥ 50 years', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '268', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Black or African Heritage', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '231', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '340', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic/Latino', 'categories': [{'measurements': [{'value': '261', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}]}]}, {'title': 'Not Permitted', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HIV-1 RNA Category', 'classes': [{'title': '< 50 copies/mL', 'categories': [{'measurements': [{'value': '285', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}]}, {'title': '50 to < 200 copies/mL', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': '200 to < 400 copies/mL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '≥ 400 copies/mL', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'CD4+ Cell Count', 'classes': [{'categories': [{'measurements': [{'value': '586', 'spread': '210.3', 'groupId': 'BG000'}, {'value': '593', 'spread': '224.6', 'groupId': 'BG001'}, {'value': '588', 'spread': '214.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells/µL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CD4+ Cell Count Category', 'classes': [{'title': '≤ 50 cells/µL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '51 to ≤ 200 cells/µL', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': '201 to ≤ 350 cells/µL', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': '351 to ≤ 500 cells/µL', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}, {'title': '> 500 cells/µL', 'categories': [{'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HIV Disease Status', 'classes': [{'title': 'Asymptomatic', 'categories': [{'measurements': [{'value': '225', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '340', 'groupId': 'BG002'}]}]}, {'title': 'Symptomatic HIV Infections', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'AIDS', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety Analysis Set: participants were randomized and received at least one dose of study drug'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 439}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'dispFirstSubmitDate': '2014-08-25', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-01', 'studyFirstSubmitDate': '2011-12-14', 'dispFirstSubmitQcDate': '2014-08-25', 'resultsFirstSubmitDate': '2014-12-31', 'studyFirstSubmitQcDate': '2011-12-16', 'dispFirstPostDateStruct': {'date': '2014-08-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-01-22', 'studyFirstPostDateStruct': {'date': '2011-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48', 'timeFrame': 'Week 48', 'description': "The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96', 'timeFrame': 'Week 96', 'description': "The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time."}, {'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV-1', 'HIV', 'Treatment Experienced'], 'conditions': ['Acquired Immunodeficiency Syndrome', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '28689453', 'type': 'DERIVED', 'citation': 'Pozniak A, Flamm J, Antinori A, Bloch M, Ward D, Berenguer J, Cote P, Andreatta K, Garner W, Szwarcberg J, Nguyen-Cleary T, McColl DJ, Piontkowsky D. Switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir DF from non-nucleoside reverse transcriptase inhibitor plus coformulated emtricitabine and tenofovir DF regimens: Week 96 results of STRATEGY-NNRTI. HIV Clin Trials. 2017 Jul;18(4):141-148. doi: 10.1080/15284336.2017.1338844. Epub 2017 Jul 9.'}, {'pmid': '24908550', 'type': 'DERIVED', 'citation': 'Pozniak A, Markowitz M, Mills A, Stellbrink HJ, Antela A, Domingo P, Girard PM, Henry K, Nguyen T, Piontkowsky D, Garner W, White K, Guyer B. Switching to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus continuation of non-nucleoside reverse transcriptase inhibitor with emtricitabine and tenofovir in virologically suppressed adults with HIV (STRATEGY-NNRTI): 48 week results of a randomised, open-label, phase 3b non-inferiority trial. Lancet Infect Dis. 2014 Jul;14(7):590-9. doi: 10.1016/S1473-3099(14)70796-0. Epub 2014 Jun 5.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the noninferiority of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse transcriptase inhibitor (NNRTI) plus Truvada® (FTC/TDF) in maintaining HIV-1 RNA \\< 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ability to understand and sign a written informed consent form\n* Be stable on the current formulation(s) of an antiretroviral regimen consisting of an NNRTI plus FTC/TDF for ≥ 6 consecutive months preceding the screening visit. This includes those who began a regimen with individual drug components and subsequently simplified to include a fixed-dose combination formulation of the same drugs.\n* Be on the first or second antiretroviral regimen with documented undetectable plasma HIV 1 RNA levels for ≥ 6 months preceding the screening visit\n* No previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) for any length of time\n* Documented historical genotype prior to starting initial antiretroviral therapy showing no known resistance to TDF or FTC\n* HIV RNA \\< 50 copies/mL at screening\n* Normal ECG\n* Hepatic transaminases ≤ 5 × the upper limit of the normal range (ULN)\n* Total bilirubin ≤ 1.5 mg/dL\n* Adequate hematologic function\n* Serum amylase ≤ 5 × ULN\n* Estimated glomerular filtration rate ≥ 70 mL/min\n* Females of childbearing potential must agree to utilize protocol recommended contraception methods or be nonheterosexually active, practice sexual abstinence from screening throughout the duration of the study period and for 12 weeks for participants on EFV/FTC/TDF or efavirenz or 30 days for the rest of participants following the last dose of study drug\n* Female participants who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing\n* Male participants must agree to utilize protocol-recommended methods of contraception during heterosexual intercourse or be nonheterosexually active, and practice sexual abstinence from the screening visit.\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* New AIDS-defining condition diagnosed within the 30 days prior to screening\n* Females who are breastfeeding\n* Positive serum pregnancy test (female of childbearing potential)\n* Receiving drug treatment for hepatitis C, or those who are anticipated to receive treatment for hepatitis C during the course of the study\n* Experiencing decompensated cirrhosis\n* Have an implanted defibrillator or pacemaker\n* Current alcohol or substance abuse that would interfere with compliance\n* A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma. Persons with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of baseline and must not be anticipated to require systemic therapy during the study.\n* Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline\n* Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study\n* Receiving ongoing therapy with any of the medications, including drugs not to be used with elvitegravir, cobicistat, FTC, or TDF; or those with any known allergies to the excipients of E/C/F/TDF tablets, or FTC/TDF tablets\n* No anticipated need to initiate drugs during the study that are contraindicated\n* Receiving other investigational drugs\n* Participation in any other clinical trial\n* Any other clinical condition or prior therapy that would make the participant unsuitable for the study or unable to comply with the dosing requirements"}, 'identificationModule': {'nctId': 'NCT01495702', 'briefTitle': 'Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 3b Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) Plus Emtricitabine (FTC) and Tenofovir DF (TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients', 'orgStudyIdInfo': {'id': 'GS-US-236-0121'}, 'secondaryIdInfos': [{'id': '2011-004963-56', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stribild', 'description': 'Participants will switch from their baseline treatment regimen to Stribild for up to 96 weeks, and may continue to receive Stribild in the extension phase.', 'interventionNames': ['Drug: Stribild']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NNRTI+FTC/TDF', 'description': 'Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of an NNRTI plus FTC/TDF for up to 96 weeks, and may switch to Stribild in the extension phase.', 'interventionNames': ['Drug: NNRTI', 'Drug: FTC/TDF', 'Drug: Stribild']}], 'interventions': [{'name': 'NNRTI', 'type': 'DRUG', 'description': 'NNRTI agents administered according to prescribing information; allowed NNRTIs include efavirenz (EFV), nevirapine, or rilpivirine.', 'armGroupLabels': ['NNRTI+FTC/TDF']}, {'name': 'FTC/TDF', 'type': 'DRUG', 'otherNames': ['Truvada'], 'description': 'FTC/TDF (200/300 mg) administered according to prescribing information', 'armGroupLabels': ['NNRTI+FTC/TDF']}, {'name': 'Stribild', 'type': 'DRUG', 'description': 'Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food', 'armGroupLabels': ['NNRTI+FTC/TDF', 'Stribild']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Spectrum Medical Group', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'AHF Research Center', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Oak Medical Group', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '94545', 'city': 'Hayward', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente', 'geoPoint': {'lat': 37.66882, 'lon': -122.0808}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Peter J. Ruane, MD, Inc.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90059', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'OASIS Clinic', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90069', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Anthony Mills MD Inc', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94602', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Alameda County Medical Center', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Group', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'La Playa Medical Group and Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Metropolis Medical', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Dupont Circle Physicians Group, P.C.', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20036', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Capital Medical Associates, P.C.', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Gary Richmond MD, PA, Inc', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '34982', 'city': 'Ft. 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