Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:57 PM
Study NCT ID:
NCT01384734
Status:
COMPLETED
Last Update Posted:
2018-11-14
First Post:
2011-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'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': 'C576364', 'term': 'fostemsavir'}, {'id': 'D000068898', 'term': 'Raltegravir Potassium'}, {'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'D000069446', 'term': 'Atazanavir Sulfate'}], 'ancestors': [{'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days', 'description': 'The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.', 'eventGroups': [{'id': 'EG000', 'title': 'FTR/RAL/TDF Total', 'description': 'All participants who were randomized to receive either of FTR 400mg BID, 800 mg BID, 600mg QD or 1200 mg QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).', 'otherNumAtRisk': 200, 'deathsNumAtRisk': 200, 'otherNumAffected': 163, 'seriousNumAtRisk': 200, 'deathsNumAffected': 3, 'seriousNumAffected': 35}, {'id': 'EG001', 'title': 'ATV/r/RAL/TDF', 'description': 'Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 46, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 52, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 47, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 62, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 19, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 43, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 34, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 12, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 48, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 16, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 18, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 64, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 18, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 25, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 22, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 9, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 35, 'numAffected': 11}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ocular icterus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 21, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Bone tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cellulitis staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Disseminated tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lymphangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Meningoencephalitis herpetic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gun shot wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oesophageal varices haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acute stress disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Post herpetic neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Adenocarcinoma of salivary gland', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ovarian neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Obstructive airways disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hysterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'FTR 400 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).'}, {'id': 'OG001', 'title': 'FTR 800 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG002', 'title': 'FTR 600 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG003', 'title': 'FTR 1200 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG004', 'title': 'ATV/r/RAL/TDF', 'description': 'Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '66.3', 'upperLimit': '90.0'}, {'value': '69', 'groupId': 'OG001', 'lowerLimit': '54.6', 'upperLimit': '81.7'}, {'value': '76', 'groupId': 'OG002', 'lowerLimit': '62.5', 'upperLimit': '87.2'}, {'value': '72', 'groupId': 'OG003', 'lowerLimit': '57.5', 'upperLimit': '83.8'}, {'value': '75', 'groupId': 'OG004', 'lowerLimit': '60.4', 'upperLimit': '85.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Percentage of participants with plasma HIV 1 RNA \\< 50 c/mL at Week 24 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage confidence intervals (CI). Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest. Intent-To-Treat-Exposed (ITT-E) Population includes all randomized participants who received at least one dose of study treatment.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'FTR 400 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).'}, {'id': 'OG001', 'title': 'FTR 800 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG002', 'title': 'FTR 600 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG003', 'title': 'FTR 1200 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG004', 'title': 'ATV/r/RAL/TDF', 'description': 'Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.'}], 'classes': [{'title': 'SAE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'AEs leading to discontinuation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 24', 'description': 'Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety population included all participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week 24 included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 24 visit snapshot window.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FTR 400 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).'}, {'id': 'OG001', 'title': 'FTR 800 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG002', 'title': 'FTR 600 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG003', 'title': 'FTR 1200 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}], 'classes': [{'title': 'Day 2, n=7, 5, 10, 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.220', 'spread': '0.1630', 'groupId': 'OG000'}, {'value': '0.149', 'spread': '0.1820', 'groupId': 'OG001'}, {'value': '0.126', 'spread': '0.1811', 'groupId': 'OG002'}, {'value': '0.126', 'spread': '0.4216', 'groupId': 'OG003'}]}]}, {'title': 'Day 5, n=7, 4, 10, 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.340', 'spread': '0.3185', 'groupId': 'OG000'}, {'value': '-0.811', 'spread': '0.3455', 'groupId': 'OG001'}, {'value': '-0.593', 'spread': '0.2429', 'groupId': 'OG002'}, {'value': '-0.767', 'spread': '0.6388', 'groupId': 'OG003'}]}]}, {'title': 'Day 6, n=7, 5, 10, 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.530', 'spread': '0.3170', 'groupId': 'OG000'}, {'value': '-1.082', 'spread': '0.3388', 'groupId': 'OG001'}, {'value': '-0.822', 'spread': '0.3076', 'groupId': 'OG002'}, {'value': '-1.053', 'spread': '0.7491', 'groupId': 'OG003'}]}]}, {'title': 'Day 7, n=6, 5, 10, 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.556', 'spread': '0.4264', 'groupId': 'OG000'}, {'value': '-1.443', 'spread': '0.4484', 'groupId': 'OG001'}, {'value': '-1.086', 'spread': '0.4216', 'groupId': 'OG002'}, {'value': '-1.198', 'spread': '0.6863', 'groupId': 'OG003'}]}]}, {'title': 'Day 8, n=6, 4, 9, 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.691', 'spread': '0.5380', 'groupId': 'OG000'}, {'value': '-1.372', 'spread': '0.3208', 'groupId': 'OG001'}, {'value': '-1.218', 'spread': '0.3902', 'groupId': 'OG002'}, {'value': '-1.470', 'spread': '0.6570', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to Day 8 of the monotherapy period', 'description': 'Change from monotherapy Baseline in log10 HIV RNA to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. ITT-E Monotherapy Population comprised of participants that were randomized and participated in the monotherapy sub-study and received at least one dose of FTR Monotherapy. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).', 'unitOfMeasure': 'log10 c/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Monotherapy Population'}, {'type': 'SECONDARY', 'title': 'Maximum Decrease From Monotherapy Baseline in log10 Plasma HIV-1 RNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FTR 400 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).'}, {'id': 'OG001', 'title': 'FTR 800 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG002', 'title': 'FTR 600 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG003', 'title': 'FTR 1200 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.770', 'spread': '0.4487', 'groupId': 'OG000'}, {'value': '-1.524', 'spread': '0.3898', 'groupId': 'OG001'}, {'value': '-1.250', 'spread': '0.3818', 'groupId': 'OG002'}, {'value': '-1.399', 'spread': '0.6688', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to Day 8 of the monotherapy period', 'description': 'Maximum decrease from monotherapy Baseline in log10 plasma HIV-1 RNA during monotherapy to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. The data for monotherapy nadir has been presented where nadir represents the maximum decrease from Baseline.', 'unitOfMeasure': 'log10 c/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Monotherapy Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Day 8 of the Monotherapy Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FTR 400 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).'}, {'id': 'OG001', 'title': 'FTR 800 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG002', 'title': 'FTR 600 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG003', 'title': 'FTR 1200 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '45.9'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '11', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '48.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 8 of the monotherapy period', 'description': 'Percentage of participants with plasma HIV 1 RNA \\< 50 c/mL at Baseline of combination therapy was assessed to evaluate the antiviral activity of four doses of FTR. Baseline of combination therapy was the Day 1 of the combination therapy. Virologic success or failure was determined using the non-missing viral load value at Baseline of combination therapy. The assessment closest to the window target Study Day was used for the analysis. Only those participants with data available at the specified time points were analyzed.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Monotherapy Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With SAE and Discontinuation Due to AEs During Monotherapy Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FTR 400 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).'}, {'id': 'OG001', 'title': 'FTR 800 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG002', 'title': 'FTR 600 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG003', 'title': 'FTR 1200 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}], 'classes': [{'title': 'SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'AEs leading to discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 8 of the monotherapy period', 'description': 'Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Monotherapy Population'}, {'type': 'SECONDARY', 'title': 'Change From Monotherapy Baseline in Cluster of Differentiation (CD)4+ and CD8+ T-cell Counts During Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FTR 400 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).'}, {'id': 'OG001', 'title': 'FTR 800 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG002', 'title': 'FTR 600 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG003', 'title': 'FTR 1200 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}], 'classes': [{'title': 'CD4+', 'categories': [{'measurements': [{'value': '58.4', 'spread': '81.60', 'groupId': 'OG000'}, {'value': '134.8', 'spread': '25.70', 'groupId': 'OG001'}, {'value': '71.8', 'spread': '117.68', 'groupId': 'OG002'}, {'value': '63.4', 'spread': '100.86', 'groupId': 'OG003'}]}]}, {'title': 'CD8+', 'categories': [{'measurements': [{'value': '134.2', 'spread': '180.64', 'groupId': 'OG000'}, {'value': '216.3', 'spread': '215.57', 'groupId': 'OG001'}, {'value': '188.0', 'spread': '363.58', 'groupId': 'OG002'}, {'value': '67.6', 'spread': '236.55', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 8', 'description': 'Blood was collected and CD4+ and CD8+ cell count assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed.', 'unitOfMeasure': 'cells per cubic millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Monotherapy Population'}, {'type': 'SECONDARY', 'title': 'Change From Monotherapy Baseline in CD4+ and CD8+ T-cell Proportion During Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FTR 400 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).'}, {'id': 'OG001', 'title': 'FTR 800 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG002', 'title': 'FTR 600 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG003', 'title': 'FTR 1200 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}], 'classes': [{'title': 'CD4+', 'categories': [{'measurements': [{'value': '-0.005', 'spread': '0.0084', 'groupId': 'OG000'}, {'value': '0.023', 'spread': '0.0299', 'groupId': 'OG001'}, {'value': '0.008', 'spread': '0.0335', 'groupId': 'OG002'}, {'value': '0.014', 'spread': '0.0320', 'groupId': 'OG003'}]}]}, {'title': 'CD8+', 'categories': [{'measurements': [{'value': '-0.003', 'spread': '0.0273', 'groupId': 'OG000'}, {'value': '-0.040', 'spread': '0.0245', 'groupId': 'OG001'}, {'value': '-0.009', 'spread': '0.0465', 'groupId': 'OG002'}, {'value': '-0.021', 'spread': '0.0364', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 8', 'description': 'Blood was collected and CD4+ and CD8+ proportion assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed.', 'unitOfMeasure': 'cells per cubic millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Monotherapy Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Primary Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'FTR 400 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).'}, {'id': 'OG001', 'title': 'FTR 800 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG002', 'title': 'FTR 600 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG003', 'title': 'FTR 1200 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG004', 'title': 'ATV/r/RAL/TDF', 'description': 'Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.'}], 'classes': [{'title': 'Week 48', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000', 'lowerLimit': '68.6', 'upperLimit': '91.4'}, {'value': '61', 'groupId': 'OG001', 'lowerLimit': '46.2', 'upperLimit': '74.8'}, {'value': '69', 'groupId': 'OG002', 'lowerLimit': '54.1', 'upperLimit': '80.9'}, {'value': '68', 'groupId': 'OG003', 'lowerLimit': '53.3', 'upperLimit': '80.5'}, {'value': '71', 'groupId': 'OG004', 'lowerLimit': '56.2', 'upperLimit': '82.5'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000', 'lowerLimit': '64.0', 'upperLimit': '88.5'}, {'value': '49', 'groupId': 'OG001', 'lowerLimit': '34.4', 'upperLimit': '63.7'}, {'value': '63', 'groupId': 'OG002', 'lowerLimit': '48.1', 'upperLimit': '75.9'}, {'value': '58', 'groupId': 'OG003', 'lowerLimit': '43.2', 'upperLimit': '71.8'}, {'value': '57', 'groupId': 'OG004', 'lowerLimit': '42.2', 'upperLimit': '70.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 48 and 96', 'description': 'Percentage of participants with plasma HIV 1 RNA \\< 50 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage CI. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With SAE and Discontinuation Due to AEs During Primary Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'FTR 400 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).'}, {'id': 'OG001', 'title': 'FTR 800 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG002', 'title': 'FTR 600 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG003', 'title': 'FTR 1200 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG004', 'title': 'ATV/r/RAL/TDF', 'description': 'Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.'}], 'classes': [{'title': 'SAE, Week 48', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'SAE, Week 96', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'AEs leading to discontinuation, Week 48', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'AEs leading to discontinuation, Week 96', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 48 and 96', 'description': 'Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety Population comprised of participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week X (where X = 48 or 96) included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 48 and 96 visit snapshot window.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ T-cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'FTR 400 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).'}, {'id': 'OG001', 'title': 'FTR 800 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG002', 'title': 'FTR 600 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG003', 'title': 'FTR 1200 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG004', 'title': 'ATV/r/RAL/TDF', 'description': 'Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.'}], 'classes': [{'title': 'Week 24, n=41, 38, 48, 42, 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '134.3', 'spread': '84.63', 'groupId': 'OG000'}, {'value': '111.0', 'spread': '123.75', 'groupId': 'OG001'}, {'value': '109.5', 'spread': '87.20', 'groupId': 'OG002'}, {'value': '124.5', 'spread': '111.04', 'groupId': 'OG003'}, {'value': '119.4', 'spread': '142.85', 'groupId': 'OG004'}]}]}, {'title': 'Week 48, n=43, 34, 43, 41, 41', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '199.1', 'spread': '124.24', 'groupId': 'OG000'}, {'value': '158.7', 'spread': '118.70', 'groupId': 'OG001'}, {'value': '140.5', 'spread': '97.16', 'groupId': 'OG002'}, {'value': '155.4', 'spread': '107.06', 'groupId': 'OG003'}, {'value': '178.7', 'spread': '133.90', 'groupId': 'OG004'}]}]}, {'title': 'Week 96, n=42, 28, 35, 28, 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '264.6', 'spread': '147.83', 'groupId': 'OG000'}, {'value': '210.8', 'spread': '158.03', 'groupId': 'OG001'}, {'value': '175.7', 'spread': '98.28', 'groupId': 'OG002'}, {'value': '211.7', 'spread': '151.03', 'groupId': 'OG003'}, {'value': '250.1', 'spread': '217.54', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 24, 48 and 96', 'description': 'Blood was collected and CD4+ cell count assessment by flow cytometery was carried out at Baseline (Day 1), Weeks 24, 48 and 96 to evaluate the immunological activity of multiple doses of BMS-663068/GSK3684934. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).', 'unitOfMeasure': 'Cells per cubic millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Newly-emergent Genotypic Substitutions at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'FTR 400 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).'}, {'id': 'OG001', 'title': 'FTR 800 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG002', 'title': 'FTR 600 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG003', 'title': 'FTR 1200 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG004', 'title': 'ATV/r/RAL/TDF', 'description': 'Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.'}], 'classes': [{'title': 'PI substitution', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'RT substitution', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Integrase substitution', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 24', 'description': 'Participants who administered antiretroviral (ARV) with virologic failure (VF) were assessed. Genotypic substitution included assessment of Reverse Transcriptase (RT) substitution, Protease Inhibitor (PI) substitution and Integrase RAL substitution as per International Acquired Immune Deficiency Syndrome (AIDS) Society-USA (IAS-USA) list. ITT-E Resistance Tested through Week 24 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 24 Snapshot analysis window. The criteria for resistance tested was participant who had virologic failure or met the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA \\< 50 c/mL) and have confirmed plasma HIV-1 RNA \\>= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA \\< 50 c/mL) after Week 8 with last plasma HIV-1 RNA \\>=400 c/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Resistance Tested through Week 24 Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Newly-emergent Genotypic Substitutions at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'FTR 400 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).'}, {'id': 'OG001', 'title': 'FTR 800 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG002', 'title': 'FTR 600 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG003', 'title': 'FTR 1200 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG004', 'title': 'ATV/r/RAL/TDF', 'description': 'Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.'}], 'classes': [{'title': 'PI substitution', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'RT substitution', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Integrase substitution', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 48', 'description': 'Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 48 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 48 Snapshot analysis window. The criteria for resistance tested was participant who had virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA \\< 50 c/mL) and have confirmed plasma HIV-1 RNA \\>= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA \\< 50 c/mL) after Week 8 with last plasma HIV-1 RNA \\>=400 c/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Resistance Tested through Week 48 Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Newly-emergent Genotypic Substitutions at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'FTR 400 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).'}, {'id': 'OG001', 'title': 'FTR 800 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG002', 'title': 'FTR 600 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG003', 'title': 'FTR 1200 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG004', 'title': 'ATV/r/RAL/TDF', 'description': 'Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.'}], 'classes': [{'title': 'PI substitution', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'RT substitution', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Integrase RAL substitution', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 96', 'description': 'Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 96 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 96 Snapshot analysis window. The criteria for resistance tested was participants with virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA \\< 50 c/mL) and have confirmed plasma HIV-1 RNA \\>= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA \\< 50 c/mL) after Week 8 with last plasma HIV-1 RNA \\>=400 c/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Resistance Tested through Week 96 Population'}, {'type': 'SECONDARY', 'title': 'Maximum Change From Baseline in Inhibitory Concentration at 50% (IC50) Fold Change Among Participants With VF at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FTR 400 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).'}, {'id': 'OG001', 'title': 'FTR 800 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG002', 'title': 'FTR 600 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG003', 'title': 'FTR 1200 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.350', 'spread': '3.4536', 'groupId': 'OG000'}, {'value': '1014.748', 'spread': '2015.5876', 'groupId': 'OG001'}, {'value': '101.627', 'spread': '190.4849', 'groupId': 'OG002'}, {'value': '39.030', 'spread': '55.1119', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to Week 24', 'description': 'Virologic failure is defined clinically as confirmed plasma HIV-1 RNA \\>= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA \\>=50 copies/mL at any time after prior confirmed suppression to \\<50 copies/mL OR confirmed \\>1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was \\>= 50 copies/mL . The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed.', 'unitOfMeasure': 'IC50 Fold Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Resistance Tested through Week 24 Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in IC50 Fold Change Among Participants With VF at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FTR 400 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).'}, {'id': 'OG001', 'title': 'FTR 800 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG002', 'title': 'FTR 600 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG003', 'title': 'FTR 1200 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.624', 'spread': '3.2819', 'groupId': 'OG000'}, {'value': '586.776', 'spread': '1521.9126', 'groupId': 'OG001'}, {'value': '81.729', 'spread': '165.4931', 'groupId': 'OG002'}, {'value': '449.092', 'spread': '647.9828', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to Week 48', 'description': 'Virologic failure is defined clinically as confirmed plasma HIV-1 RNA \\>= 50 copies/mL at Week 24 or later or later or virologic rebound defined as confirmed HIV-1 RNA \\>=50 copies/mL at any time after prior confirmed suppression to \\<50 copies/mL OR confirmed \\>1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was \\>= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed.', 'unitOfMeasure': 'IC50 Fold Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Resistance Tested through Week 48 Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in IC50 Fold Change Among Participants With VF at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FTR 400 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).'}, {'id': 'OG001', 'title': 'FTR 800 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG002', 'title': 'FTR 600 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'OG003', 'title': 'FTR 1200 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}], 'classes': [{'categories': [{'measurements': [{'value': '25.480', 'spread': '68.9030', 'groupId': 'OG000'}, {'value': '419.901', 'spread': '1092.5929', 'groupId': 'OG001'}, {'value': '46.351', 'spread': '157.9219', 'groupId': 'OG002'}, {'value': '777.818', 'spread': '1550.8887', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to Week 96', 'description': 'Virologic failure is defined clinically as confirmed plasma HIV-1 RNA \\>= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA \\>=50 copies/mL at any time after prior confirmed suppression to \\<50 copies/mL OR confirmed \\>1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was \\>= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed.', 'unitOfMeasure': 'IC50 Fold Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Resistance Tested through Week 96 Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FTR 400 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 400 milligrams (mg) FTR twice daily (BID) (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).'}, {'id': 'FG001', 'title': 'FTR 800 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'FG002', 'title': 'FTR 600 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'FG003', 'title': 'FTR 1200 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'FG004', 'title': 'ATV/r/RAL/TDF', 'description': 'Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '50'}, {'groupId': 'FG004', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Continuation criteria not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Sponsor terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'Investigator relocating', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Unable to come back for visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Prison', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'As per Exclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Missed End of treatment visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adhesion problem', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Early termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants with Human Immunodeficiency Virus (HIV-1) were randomized in ratio of 1:1:1:1:1 to 5 treatment arms of the study. Four groups with distinct dose of Fostemsavir (FTR, also referred BMS-663068) with Raltegravir (RAL) Tenofovir Disoproxil Fumarate (TDF). There was a reference group with ritonavir (r) boosted atazanavir (ATV), RAL and TDF.', 'preAssignmentDetails': 'A total of 581 participants were screened, 254 were enrolled of which 2 participants withdrew consent and 1 was randomized in error. A total 251 participants were randomized and treated of which 32 were in Monotherapy sub-study (only FTR) and continued to Primary study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '251', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'FTR 400 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).'}, {'id': 'BG001', 'title': 'FTR 800 mg BID/RAL/TDF', 'description': 'Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'BG002', 'title': 'FTR 600 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'BG003', 'title': 'FTR 1200 mg QD/RAL/TDF', 'description': 'Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).'}, {'id': 'BG004', 'title': 'ATV/r/RAL/TDF', 'description': 'Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.1', 'spread': '8.17', 'groupId': 'BG000'}, {'value': '38.4', 'spread': '9.49', 'groupId': 'BG001'}, {'value': '40.1', 'spread': '9.45', 'groupId': 'BG002'}, {'value': '39.2', 'spread': '11.41', 'groupId': 'BG003'}, {'value': '39.7', 'spread': '10.63', 'groupId': 'BG004'}, {'value': '39.1', 'spread': '9.84', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '100', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}, {'value': '151', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'African American/African Heritage', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '76', 'groupId': 'BG005'}]}, {'title': 'American Indian Or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '95', 'groupId': 'BG005'}]}, {'title': 'Other/Mixed', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '75', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 254}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-16', 'studyFirstSubmitDate': '2011-06-23', 'resultsFirstSubmitDate': '2018-08-16', 'studyFirstSubmitQcDate': '2011-06-28', 'lastUpdatePostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-16', 'studyFirstPostDateStruct': {'date': '2011-06-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24', 'timeFrame': 'Week 24', 'description': 'Percentage of participants with plasma HIV 1 RNA \\< 50 c/mL at Week 24 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage confidence intervals (CI). Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest. Intent-To-Treat-Exposed (ITT-E) Population includes all randomized participants who received at least one dose of study treatment.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24', 'timeFrame': 'Up to Week 24', 'description': 'Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety population included all participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week 24 included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 24 visit snapshot window.'}], 'secondaryOutcomes': [{'measure': 'Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period', 'timeFrame': 'Baseline and up to Day 8 of the monotherapy period', 'description': 'Change from monotherapy Baseline in log10 HIV RNA to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. ITT-E Monotherapy Population comprised of participants that were randomized and participated in the monotherapy sub-study and received at least one dose of FTR Monotherapy. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).'}, {'measure': 'Maximum Decrease From Monotherapy Baseline in log10 Plasma HIV-1 RNA', 'timeFrame': 'Baseline and up to Day 8 of the monotherapy period', 'description': 'Maximum decrease from monotherapy Baseline in log10 plasma HIV-1 RNA during monotherapy to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. The data for monotherapy nadir has been presented where nadir represents the maximum decrease from Baseline.'}, {'measure': 'Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Day 8 of the Monotherapy Period', 'timeFrame': 'Up to Day 8 of the monotherapy period', 'description': 'Percentage of participants with plasma HIV 1 RNA \\< 50 c/mL at Baseline of combination therapy was assessed to evaluate the antiviral activity of four doses of FTR. Baseline of combination therapy was the Day 1 of the combination therapy. Virologic success or failure was determined using the non-missing viral load value at Baseline of combination therapy. The assessment closest to the window target Study Day was used for the analysis. Only those participants with data available at the specified time points were analyzed.'}, {'measure': 'Number of Participants With SAE and Discontinuation Due to AEs During Monotherapy Period', 'timeFrame': 'Up to Day 8 of the monotherapy period', 'description': 'Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment.'}, {'measure': 'Change From Monotherapy Baseline in Cluster of Differentiation (CD)4+ and CD8+ T-cell Counts During Monotherapy', 'timeFrame': 'Baseline and Day 8', 'description': 'Blood was collected and CD4+ and CD8+ cell count assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed.'}, {'measure': 'Change From Monotherapy Baseline in CD4+ and CD8+ T-cell Proportion During Monotherapy', 'timeFrame': 'Baseline and Day 8', 'description': 'Blood was collected and CD4+ and CD8+ proportion assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed.'}, {'measure': 'Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Primary Study', 'timeFrame': 'Weeks 48 and 96', 'description': 'Percentage of participants with plasma HIV 1 RNA \\< 50 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage CI. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest.'}, {'measure': 'Number of Participants With SAE and Discontinuation Due to AEs During Primary Study', 'timeFrame': 'Weeks 48 and 96', 'description': 'Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety Population comprised of participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week X (where X = 48 or 96) included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 48 and 96 visit snapshot window.'}, {'measure': 'Change From Baseline in CD4+ T-cell Count', 'timeFrame': 'Baseline and Weeks 24, 48 and 96', 'description': 'Blood was collected and CD4+ cell count assessment by flow cytometery was carried out at Baseline (Day 1), Weeks 24, 48 and 96 to evaluate the immunological activity of multiple doses of BMS-663068/GSK3684934. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).'}, {'measure': 'Number of Participants With Newly-emergent Genotypic Substitutions at Week 24', 'timeFrame': 'Up to Week 24', 'description': 'Participants who administered antiretroviral (ARV) with virologic failure (VF) were assessed. Genotypic substitution included assessment of Reverse Transcriptase (RT) substitution, Protease Inhibitor (PI) substitution and Integrase RAL substitution as per International Acquired Immune Deficiency Syndrome (AIDS) Society-USA (IAS-USA) list. ITT-E Resistance Tested through Week 24 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 24 Snapshot analysis window. The criteria for resistance tested was participant who had virologic failure or met the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA \\< 50 c/mL) and have confirmed plasma HIV-1 RNA \\>= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA \\< 50 c/mL) after Week 8 with last plasma HIV-1 RNA \\>=400 c/mL.'}, {'measure': 'Number of Participants With Newly-emergent Genotypic Substitutions at Week 48', 'timeFrame': 'Up to Week 48', 'description': 'Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 48 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 48 Snapshot analysis window. The criteria for resistance tested was participant who had virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA \\< 50 c/mL) and have confirmed plasma HIV-1 RNA \\>= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA \\< 50 c/mL) after Week 8 with last plasma HIV-1 RNA \\>=400 c/mL.'}, {'measure': 'Number of Participants With Newly-emergent Genotypic Substitutions at Week 96', 'timeFrame': 'Up to Week 96', 'description': 'Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 96 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 96 Snapshot analysis window. The criteria for resistance tested was participants with virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA \\< 50 c/mL) and have confirmed plasma HIV-1 RNA \\>= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA \\< 50 c/mL) after Week 8 with last plasma HIV-1 RNA \\>=400 c/mL.'}, {'measure': 'Maximum Change From Baseline in Inhibitory Concentration at 50% (IC50) Fold Change Among Participants With VF at Week 24', 'timeFrame': 'Baseline and up to Week 24', 'description': 'Virologic failure is defined clinically as confirmed plasma HIV-1 RNA \\>= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA \\>=50 copies/mL at any time after prior confirmed suppression to \\<50 copies/mL OR confirmed \\>1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was \\>= 50 copies/mL . The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed.'}, {'measure': 'Change From Baseline in IC50 Fold Change Among Participants With VF at Week 48', 'timeFrame': 'Baseline and up to Week 48', 'description': 'Virologic failure is defined clinically as confirmed plasma HIV-1 RNA \\>= 50 copies/mL at Week 24 or later or later or virologic rebound defined as confirmed HIV-1 RNA \\>=50 copies/mL at any time after prior confirmed suppression to \\<50 copies/mL OR confirmed \\>1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was \\>= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed.'}, {'measure': 'Change From Baseline in IC50 Fold Change Among Participants With VF at Week 96', 'timeFrame': 'Baseline and up to Week 96', 'description': 'Virologic failure is defined clinically as confirmed plasma HIV-1 RNA \\>= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA \\>=50 copies/mL at any time after prior confirmed suppression to \\<50 copies/mL OR confirmed \\>1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was \\>= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Infection, Human Immunodeficiency Virus']}, 'referencesModule': {'references': [{'pmid': '27922453', 'type': 'DERIVED', 'citation': 'Thompson M, Lalezari JP, Kaplan R, Pinedo Y, Pena OAS, Cahn P, Stock DA, Joshi SR, Hanna GJ, Lataillade M; AI438011 study team. Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in antiretroviral-experienced subjects: week 48 analysis of AI438011, a Phase IIb, randomized controlled trial. Antivir Ther. 2017;22(3):215-223. doi: 10.3851/IMP3112. Epub 2016 Dec 6.'}, {'pmid': '26902761', 'type': 'DERIVED', 'citation': 'Landry I, Zhu L, Abu Tarif M, Hruska M, Sadler BM, Pitsiu M, Joshi S, Hanna GJ, Lataillade M, Boulton DW, Bertz RJ. Model-Based Phase 3 Dose Selection for HIV-1 Attachment Inhibitor Prodrug BMS-663068 in HIV-1-Infected Patients: Population Pharmacokinetics/Pharmacodynamics of the Active Moiety, BMS-626529. Antimicrob Agents Chemother. 2016 Apr 22;60(5):2782-9. doi: 10.1128/AAC.02503-15. Print 2016 May.'}, {'pmid': '26423650', 'type': 'DERIVED', 'citation': 'Lalezari JP, Latiff GH, Brinson C, Echevarria J, Trevino-Perez S, Bogner JR, Thompson M, Fourie J, Sussmann Pena OA, Mendo Urbina FC, Martins M, Diaconescu IG, Stock DA, Joshi SR, Hanna GJ, Lataillade M; AI438011 study team. Safety and efficacy of the HIV-1 attachment inhibitor prodrug BMS-663068 in treatment-experienced individuals: 24 week results of AI438011, a phase 2b, randomised controlled trial. Lancet HIV. 2015 Oct;2(10):e427-37. doi: 10.1016/S2352-3018(15)00177-0. Epub 2015 Sep 1.'}, {'pmid': '24128669', 'type': 'DERIVED', 'citation': 'Zhou N, Nowicka-Sans B, McAuliffe B, Ray N, Eggers B, Fang H, Fan L, Healy M, Langley DR, Hwang C, Lataillade M, Hanna GJ, Krystal M. Genotypic correlates of susceptibility to HIV-1 attachment inhibitor BMS-626529, the active agent of the prodrug BMS-663068. J Antimicrob Chemother. 2014 Mar;69(3):573-81. doi: 10.1093/jac/dkt412. Epub 2013 Oct 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety, efficacy, tolerability and pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + Tenofovir Disoproxil Fumarate (TDF). At least 1 dose of BMS-663068 can be identified which is safe, well tolerated, and efficacious when combined with RAL + TDF for treatment-experienced HIV-1 infected subjects. PHENOSENSE® is a registered trademark of Monogram Biosciences.', 'detailedDescription': 'Masking: Double-blind for BMS-6630368 treatment groups until the Week 24 Primary Endpoint analysis, then open label. The reference groups is all open-label.\n\nArms: 5 (4 BMS-663068 treatment groups and 1 reference group)\n\nIntervention Model: Parallel (with unblinding after the Week 24 primary endpoint analysis)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Plasma HIV-1 RNA ≥ 1000 copies/ml at Screening\n* Treatment experience with antiretroviral therapies (excluding integrase inhibitors)\n* Screening PHENOSENSE Entry indicating BMS-626529 inhibitory concentration (IC)50 \\< 0.1 μM\n* Cluster of differentiation (CD)4+ T-cell count \\> 50 cells/mm3\n\nExclusion Criteria:\n\n* History (or evidence at Screening) of genotypic resistance to any component of the study regimen \\[ Tenofovir Disoproxil Fumarate (TDF), Atazanavir (ATV), Raltegravir (RAL)\\]\n* Certain laboratory and electrocardiogram (ECG) values'}, 'identificationModule': {'nctId': 'NCT01384734', 'briefTitle': 'HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'A Phase IIb Randomized, Controlled, Partially-Blinded Trial to Investigate Safety, Efficacy and Dose-Response of BMS-663068 in Treatment-experienced HIV-1 Subjects, Followed by an Open-Label Period on the Recommended Dose', 'orgStudyIdInfo': {'id': '205889'}, 'secondaryIdInfos': [{'id': 'AI438-011', 'type': 'OTHER', 'domain': 'Bristol-Myers Squibb'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: BMS-663068 (400mg) + Raltegravir + Tenofovir', 'description': 'Treatment Group 1', 'interventionNames': ['Drug: BMS-663068 400 mg', 'Drug: Raltegravir 400 mg', 'Drug: Tenofovir 300 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: BMS-663068 (800 mg) + Raltegravir + Tenofovir', 'description': 'Treatment Group 2', 'interventionNames': ['Drug: BMS-663068 800 mg', 'Drug: Raltegravir 400 mg', 'Drug: Tenofovir 300 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C: BMS-663068 (600 mg) + Raltegravir + Tenofovir', 'description': 'Treatment Group 3', 'interventionNames': ['Drug: BMS-663068 600 mg', 'Drug: Raltegravir 400 mg', 'Drug: Tenofovir 300 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Arm D: BMS-663068 (1200 mg) + Raltegravir + Tenofovir', 'description': 'Treatment Group 4', 'interventionNames': ['Drug: BMS-663068 1200 mg', 'Drug: Raltegravir 400 mg', 'Drug: Tenofovir 300 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm E: Atazanavir + Ritonavir + Raltegravir + Tenofovir', 'description': 'Treatment Group 1 (reference arm)', 'interventionNames': ['Drug: Raltegravir 400 mg', 'Drug: Tenofovir 300 mg', 'Drug: Ritonavir 100 mg', 'Drug: Atazanavir 300 mg']}], 'interventions': [{'name': 'BMS-663068 400 mg', 'type': 'DRUG', 'description': 'Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose', 'armGroupLabels': ['Arm A: BMS-663068 (400mg) + Raltegravir + Tenofovir']}, {'name': 'BMS-663068 800 mg', 'type': 'DRUG', 'description': 'Tablets, Oral, 800 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose', 'armGroupLabels': ['Arm B: BMS-663068 (800 mg) + Raltegravir + Tenofovir']}, {'name': 'BMS-663068 600 mg', 'type': 'DRUG', 'description': 'Tablets, Oral, 600 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose', 'armGroupLabels': ['Arm C: BMS-663068 (600 mg) + Raltegravir + Tenofovir']}, {'name': 'BMS-663068 1200 mg', 'type': 'DRUG', 'description': 'Tablets, Oral, 1200 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose', 'armGroupLabels': ['Arm D: BMS-663068 (1200 mg) + Raltegravir + Tenofovir']}, {'name': 'Raltegravir 400 mg', 'type': 'DRUG', 'description': 'Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose', 'armGroupLabels': ['Arm A: BMS-663068 (400mg) + Raltegravir + Tenofovir', 'Arm B: BMS-663068 (800 mg) + Raltegravir + Tenofovir', 'Arm C: BMS-663068 (600 mg) + Raltegravir + Tenofovir', 'Arm D: BMS-663068 (1200 mg) + Raltegravir + Tenofovir', 'Arm E: Atazanavir + Ritonavir + Raltegravir + Tenofovir']}, {'name': 'Tenofovir 300 mg', 'type': 'DRUG', 'description': 'Tablets, Oral, 300 mg, Once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose', 'armGroupLabels': ['Arm A: BMS-663068 (400mg) + Raltegravir + Tenofovir', 'Arm B: BMS-663068 (800 mg) + Raltegravir + Tenofovir', 'Arm C: BMS-663068 (600 mg) + Raltegravir + Tenofovir', 'Arm D: BMS-663068 (1200 mg) + Raltegravir + Tenofovir', 'Arm E: Atazanavir + Ritonavir + Raltegravir + Tenofovir']}, {'name': 'Ritonavir 100 mg', 'type': 'DRUG', 'description': 'Tablets, Oral, 100 mg, Once daily, 96 weeks', 'armGroupLabels': ['Arm E: Atazanavir + Ritonavir + Raltegravir + Tenofovir']}, {'name': 'Atazanavir 300 mg', 'type': 'DRUG', 'description': 'Capsules, Oral, 300 mg, Once daily, 96 weeks', 'armGroupLabels': ['Arm E: Atazanavir + Ritonavir + Raltegravir + Tenofovir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94102', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '32803', 'city': 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