Viewing Study NCT01440569

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Ignite Creation Date: 2025-12-24 @ 10:58 PM
Ignite Modification Date: 2026-02-18 @ 1:55 PM
Study NCT ID: NCT01440569
Status: COMPLETED
Last Update Posted: 2016-12-14
First Post: 2011-09-22
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'France', 'Germany']}, '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': 'D000069547', 'term': 'Cobicistat'}, {'id': 'D000069454', 'term': 'Darunavir'}], 'ancestors': [{'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D005663', 'term': 'Furans'}]}}, '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}}, 'adverseEventsModule': {'timeFrame': 'Up to a maximum of 204.4 weeks (average: 139.2 weeks)', 'description': 'Safety Analysis Set', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment-Naive', 'description': 'Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.', 'otherNumAtRisk': 295, 'otherNumAffected': 261, 'seriousNumAtRisk': 295, 'seriousNumAffected': 45}, {'id': 'EG001', 'title': 'Treatment-Experienced', 'description': 'Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.', 'otherNumAtRisk': 18, 'otherNumAffected': 16, 'seriousNumAtRisk': 18, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Angle closure glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Tongue pigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Rash pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Syphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Vulvovaginitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Vulvovaginitis trichomonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Incision site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Abnormal loss of weight', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Anogenital warts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Penile wart', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Squamous cell carcinoma of the vulva', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Cerebral atrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Facial paresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Post herpetic neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 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'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Limb crushing injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': "Castleman's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': "Kaposi's sarcoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Drug dependence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Priapism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Onset of Any Treatment-emergent Grade 3 or 4 Adverse Event Between Baseline and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-Naive', 'description': 'Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.'}, {'id': 'OG001', 'title': 'Treatment-Experienced', 'description': 'Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 24 (Snapshot Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-Naive', 'description': 'Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.'}, {'id': 'OG001', 'title': 'Treatment-Experienced', 'description': 'Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.7', 'groupId': 'OG000'}, {'value': '61.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48 (Snapshot Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-Naive', 'description': 'Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.'}, {'id': 'OG001', 'title': 'Treatment-Experienced', 'description': 'Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.7', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ Cell Count at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-Naive', 'description': 'Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.'}, {'id': 'OG001', 'title': 'Treatment-Experienced', 'description': 'Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '145', 'spread': '131.6', 'groupId': 'OG000'}, {'value': '99', 'spread': '161.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 24', 'unitOfMeasure': 'cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set; the Missing = Excluded method was used, where participants with missing data were excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ Cell Count at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-Naive', 'description': 'Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.'}, {'id': 'OG001', 'title': 'Treatment-Experienced', 'description': 'Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '194', 'spread': '152.1', 'groupId': 'OG000'}, {'value': '121', 'spread': '157.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 48', 'unitOfMeasure': 'cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set; the Missing = Excluded method was used, where participants with missing data were excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-Naive', 'description': 'Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.'}, {'id': 'OG001', 'title': 'Treatment-Experienced', 'description': 'Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.'}], 'classes': [{'title': 'Any treatment-emergent adverse event (TEAE)', 'categories': [{'measurements': [{'value': '88.1', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}]}]}, {'title': 'Any TEAE that led to study drug discontinuation', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-Naive', 'description': 'Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.'}, {'id': 'OG001', 'title': 'Treatment-Experienced', 'description': 'Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.'}], 'classes': [{'title': 'Any treatment-emergent adverse event (TEAE)', 'categories': [{'measurements': [{'value': '91.5', 'groupId': 'OG000'}, {'value': '88.9', 'groupId': 'OG001'}]}]}, {'title': 'Any TEAE that led to study drug discontinuation', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 48 weeks', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment-Naive', 'description': 'Treatment-naive participants received darunavir (DRV; 800 mg; 2 × 400 mg tablets) + cobicistat (COBI; 1 × 150 mg tablet) once daily + two nucleoside analogue reverse transcriptase inhibitors (NRTIs; per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.'}, {'id': 'FG001', 'title': 'Treatment-Experienced', 'description': 'Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.'}], 'periods': [{'title': 'Main Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '296'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Enrolled and Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '295'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '260'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Enrolled but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': "Investigator's Discretion", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Subject Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Open-Label Rollover Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '9 participants who completed the Main Study did not enroll into the Rollover Phase.', 'groupId': 'FG000', 'numSubjects': '251'}, {'comment': '1 participant who completed the Main Study did not enroll into the Rollover Phase.', 'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '204'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': "Investigator's Discretion", 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Subject Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled at a total of 56 study sites in the United States. The first participant was screened on 22 September 2011. The last study visit occurred on 30 October 2015.', 'preAssignmentDetails': '397 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '313', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment-Naive', 'description': 'Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.'}, {'id': 'BG001', 'title': 'Treatment-Experienced', 'description': 'Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '45', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '36', 'spread': '10.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '266', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '231', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}]}, {'title': 'Black or African Heritage', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'CD4 Count (cells/mm^3)', 'classes': [{'categories': [{'measurements': [{'value': '378.2', 'spread': '199.94', 'groupId': 'BG000'}, {'value': '197.8', 'spread': '214.30', 'groupId': 'BG001'}, {'value': '367.8', 'spread': '204.79', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HIV-1 RNA (log10 copies/mL)', 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '0.76', 'groupId': 'BG000'}, {'value': '4.8', 'spread': '1.04', 'groupId': 'BG001'}, {'value': '4.8', 'spread': '0.78', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Background Antiretroviral Regimen', 'classes': [{'title': 'FTC/TDF', 'categories': [{'measurements': [{'value': '291', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '301', 'groupId': 'BG002'}]}]}, {'title': 'AZT+FTC/TDF', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'ABC+TDF', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'ABC+FTC/TDF', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'ABC/3TC', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'DDI+FTC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': '3TC, lamivudine (Epivir®); ABC, abacavir; ABC/3TC, abacavir/lamivudine coformulation; AZT, azidothymidine or zidovudine; DDI, didanosine; FTC, emtricitabine (Emtriva®); FTC/TDF, emtricitabine/tenofovir disoproxil fumarate coformulation (Truvada®); TDF, tenofovir disoproxil fumarate (Viread®)', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Full Analysis Set: participants who were enrolled into the study and received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 314}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'dispFirstSubmitDate': '2013-11-17', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-26', 'studyFirstSubmitDate': '2011-09-22', 'dispFirstSubmitQcDate': '2013-11-17', 'resultsFirstSubmitDate': '2014-10-23', 'studyFirstSubmitQcDate': '2011-09-23', 'dispFirstPostDateStruct': {'date': '2013-12-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-12-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-23', 'studyFirstPostDateStruct': {'date': '2011-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Onset of Any Treatment-emergent Grade 3 or 4 Adverse Event Between Baseline and Week 24', 'timeFrame': 'Up to 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 24 (Snapshot Analysis)', 'timeFrame': 'Week 24'}, {'measure': 'Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48 (Snapshot Analysis)', 'timeFrame': 'Week 48'}, {'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': 'Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 24', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 48', 'timeFrame': 'Up to 48 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV-1', 'HIV', 'Treatment Naïve', 'Treatment Experienced'], 'conditions': ['Acquired Immunodeficiency Syndrome', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected, antiretroviral treatment-naive and treatment-experienced adults with no darunavir (DRV) resistance-associated mutations.\n\nAfter the Week 48 Visit, participants will be given the option to participate in an open-label rollover phase to receive cobicistat and attend visits every 12 weeks until it becomes commercially available, or until Gilead Sciences elects to terminate development of cobicistat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult ≥ 18 years males or non-pregnant females\n* Ability to understand and sign a written informed consent form\n* General medical condition that does not interfere with the assessments and the completion of the trial\n* Treatment Naive: No prior use of any approved or investigational antiretroviral drug for any length of time OR\n* Treatment Experienced: Stable antiretroviral regimen for at least 12 weeks prior to screening\n* Plasma HIV-1 RNA levels ≥ 1000 copies/mL at Screening\n* Screening genotype report shows full sensitivity to two nucleoside analogue reverse transcriptase inhibitors (NRTIs) and no darunavir resistance-associated mutations\n* Normal electrocardiogram (ECG)\n* Hepatic transaminases ≤ 2.5 × upper limit of normal (ULN)\n* Total bilirubin ≤ 1.5 mg/dL\n* Adequate hematologic function\n* Serum amylase ≤ 2 × ULN and serum lipase ≤ 3 × ULN\n* Adequate renal function: Estimated glomerular filtration rate ≥ 80 mL/min\n* Females of childbearing potential must agree to utilize protocol-recommended methods of contraception, or be nonheterosexually active, practice sexual abstinence or have a vasectomized partner from Screening throughout the duration of the study period and for 30 days following the last dose of study drug.\n* Male subjects must agree to utilize protocol-recommended methods of contraception during heterosexual intercourse from the Screening visit, throughout the duration of the study and for 30 days following discontinuation of investigational medicinal product or be nonheterosexually active, practice sexual abstinence, or be vasectomized.\n\nExclusion Criteria:\n\n* Previous or current use of darunavir\n* A new AIDS-defining condition diagnosed within the 30 days prior to Screening\n* Females who are breastfeeding\n* Positive serum pregnancy test (if female of childbearing potential)\n* Proven or suspected acute hepatitis in the 30 days prior to study entry\n* Subjects receiving drug treatment for hepatitis C virus (HCV), or subjects who are anticipated to receive treatment for HCV during the course of the study\n* Have a history of ongoing active liver disease or experiencing decompensated cirrhosis irrespective of liver enzyme levels\n* Have an implanted defibrillator or pacemaker\n* Current alcohol or substance use that may interfere with subject study compliance\n* A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma\n* Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline\n* Participation in any other clinical trial\n* Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements.\n* Subjects receiving ongoing therapy with any of the medications, including drugs not to be used with cobicistat, darunavir, or investigator selected NRTIs; or subjects with any known allergies to cobicistat tablets, darunavir tablets or contraindications for the 2 NRTIs as part of the regimen."}, 'identificationModule': {'nctId': 'NCT01440569', 'briefTitle': 'Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 3b, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Cobicistat-boosted Darunavir Plus Two Fully Active Nucleoside Reverse Transcriptase Inhibitors in HIV-1 Infected, Antiretroviral Treatment-Naïve and -Experienced Adults With No Darunavir Resistance-associated Mutations', 'orgStudyIdInfo': {'id': 'GS-US-216-0130'}, 'secondaryIdInfos': [{'id': '2011-003501-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COBI-boosted DRV', 'description': 'Participants will receive DRV+COBI+2 investigator-selected NRTIs for 48 weeks, and may continue their regimen in the open-label rollover phase.', 'interventionNames': ['Drug: COBI', 'Drug: DRV', 'Drug: NRTIs']}], 'interventions': [{'name': 'COBI', 'type': 'DRUG', 'otherNames': ['Tybost®', 'GS-9350'], 'description': '150 mg tablet administered orally with food once daily', 'armGroupLabels': ['COBI-boosted DRV']}, {'name': 'DRV', 'type': 'DRUG', 'otherNames': ['Prezista®', 'TMC114'], 'description': '800 mg (2 x 400 mg tablets) administered orally with food once daily', 'armGroupLabels': ['COBI-boosted DRV']}, {'name': 'NRTIs', 'type': 'DRUG', 'description': 'Participants will receive 2 nucleoside analogue reverse transcriptase inhibitors (NRTIs) selected by the investigator after resistance testing at screening and administered according to prescribing information. NRTIs may include emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), zidovudine+FTC/TDF, abacavir (ABC)+TDF, ABC+FTC/TDF, ABC+lamivudine (3TC), or didanosine (DDI)+FTC.', 'armGroupLabels': ['COBI-boosted DRV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Spectrum Medical Group', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90813', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach Education and Research Consultants, PC', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Peter J Ruane MD Inc.', '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': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'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': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Apex Research LLC', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Dupont Circle Physician's Group", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Whitman-Walker Health', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Gary J. 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States', 'facility': 'Gordon Crofoot MD, PA', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75605', 'city': 'Longview', 'state': 'Texas', 'country': 'United States', 'facility': 'DCOL Center for Clinical Research', 'geoPoint': {'lat': 32.5007, 'lon': -94.74049}}, {'zip': '22003', 'city': 'Annandale', 'state': 'Virginia', 'country': 'United States', 'facility': 'Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)', 'geoPoint': {'lat': 38.83039, 'lon': -77.19637}}, {'zip': '89104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '00909', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Clinical Research Puerto Rico', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Marshall Fordyce, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}