Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT02415595
Status:
TERMINATED
Last Update Posted:
2018-09-19
First Post:
2015-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose-finding Study of BMS-955176 to Treat HIV-1 Infected Treatment-naive Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico', 'Thailand']}, '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': 'C000627567', 'term': 'BMS-955176'}]}}, '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': 'Non-serious adverse events and serious adverse events (SAEs) were collected from the start of study treatment until Week 96.', 'description': 'Non-SAEs and SAEs were collected in the mITT Population, which comprised of all participants who received at least one dose of BMS-955176/GSK3532795 or EFV.', 'eventGroups': [{'id': 'EG000', 'title': 'BMS-955176/GSK3532795 60 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label tenofovir/emtricitabine (TDF/FTC) 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 41, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'BMS-955176/GSK3532795 120 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 46, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'BMS-955176/GSK3532795 180 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 45, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'EFV 600 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 48, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 30, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 33, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 58, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urethritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anogenital warts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 27, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Intervertebral discitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Metapneumovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pelvic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastrointestinal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Orthostatic intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <40 Copies Per Milliliter (c/mL) at Week 24 Using Food and Drug Administration (FDA) Snapshot Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-955176/GSK3532795 60 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG001', 'title': 'BMS-955176/GSK3532795 120 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.'}, {'id': 'OG002', 'title': 'BMS-955176/GSK3532795 180 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG003', 'title': 'EFV 600 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV 1 RNA \\<40 c/mL at Week 24 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window (18 to 30 weeks) to determine response. Analysis was performed on mITT Population, which comprised of randomized participants who received at least 1 dose of BMS-955176/GSK3532795 or EFV.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Plasma HIV-1 RNA < 40 c/mL at Weeks 48 and 96 Using FDA Snapshot Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-955176/GSK3532795 60 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG001', 'title': 'BMS-955176/GSK3532795 120 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.'}, {'id': 'OG002', 'title': 'BMS-955176/GSK3532795 180 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG003', 'title': 'EFV 600 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}], 'classes': [{'title': 'Week 48; n=40, 42, 40, 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}, {'title': 'Week 96; n=0, 0, 0, 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 48 and 96', 'description': 'Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV 1 RNA \\<40 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response. The analysis was performed using mITT Population (observed), which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). The data was not collected for Week 96 analysis; as the study was terminated early. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population (observed)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Week 24 Using FDA Snapshot Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-955176/GSK3532795 60 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG001', 'title': 'BMS-955176/GSK3532795 120 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.'}, {'id': 'OG002', 'title': 'BMS-955176/GSK3532795 180 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG003', 'title': 'EFV 600 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV-1 RNA \\<200 c/mL at Week 24 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Weeks 48 and 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-955176/GSK3532795 60 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label tenofovir/emtricitabine (TDF/FTC) 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG001', 'title': 'BMS-955176/GSK3532795 120 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.'}, {'id': 'OG002', 'title': 'BMS-955176/GSK3532795 180 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG003', 'title': 'EFV 600 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}], 'classes': [{'title': 'Week 48; n=40, 42, 40, 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}]}, {'title': 'Week 96; n=0, 0, 0, 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 48 and 96', 'description': 'Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV-1 RNA \\<200 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response. The analysis was performed using mITT Population (observed), which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). The data was not collected for Week 96 analysis; as the study was terminated early. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population (observed)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Newly Emergent Genotypic Resistance Using All On-treatment Isolates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-955176/GSK3532795 60 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG001', 'title': 'BMS-955176/GSK3532795 120 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.'}, {'id': 'OG002', 'title': 'BMS-955176/GSK3532795 180 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG003', 'title': 'EFV 600 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}], 'classes': [{'title': 'Protease inhibitor substitution', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Reverse transcriptase substitution', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'The emergence of genotypic resistance among samples selected for drug resistance testing were assessed by searching for all reverse transcriptase substitutions and protease inhibitor substitutions listed in the International Acquired Immunodeficiency Syndrome (AIDS) Society-United States of America (IAS-USA) list of HIV-1 drug resistance mutations. The outcome was originally designed to be assessed up to 96 weeks of treatment, but it was analyzed up to Week 24 as the study was terminated early. The emergence of genotypic resistance is presented for participants in the mITT Population who had Baseline and on-treatment genotypic resistance testing and who had successful sequencing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Only participants with Baseline and on-treatment genotypic resistance testing and who had successful sequencing were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Newly Emergent Phenotypic Resistance Using All On-treatment Isolates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-955176/GSK3532795 60 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label tenofovir/emtricitabine (TDF/FTC) 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG001', 'title': 'BMS-955176/GSK3532795 120 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.'}, {'id': 'OG002', 'title': 'BMS-955176/GSK3532795 180 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG003', 'title': 'EFV 600 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'Phenotypic resistance to a drug is defined as a fold change (i.e., ratio of the 50% inhibitory concentration (IC50) of the clinical isolate to the IC50 of the reference strain) which is greater than the cut-off for reduced susceptibility. Emergent phenotypic resistance to BMS-955176/GSK3532795 was defined as a Baseline fold change IC50\\<= 3 and an on-treatment fold change IC50\\>3. The number of participants with newly emergent phenotypic resistance is presented for participants in the mITT Population who had Baseline and on-treatment phenotypic resistance testing. The outcome was originally designed to be assessed up to 96 weeks of treatment, but it was analyzed up to Week 24 as the study was terminated early.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Only participants who had Baseline and on-treatment phenotypic resistance testing were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-955176/GSK3532795 60 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label tenofovir/emtricitabine (TDF/FTC) 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG001', 'title': 'BMS-955176/GSK3532795 120 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.'}, {'id': 'OG002', 'title': 'BMS-955176/GSK3532795 180 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG003', 'title': 'EFV 600 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}], 'classes': [{'title': 'Week 2, n=8, 6, 10, 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.927', 'spread': '0.3726', 'groupId': 'OG000'}, {'value': '-1.930', 'spread': '0.4785', 'groupId': 'OG001'}, {'value': '-2.006', 'spread': '0.3783', 'groupId': 'OG002'}, {'value': '-2.003', 'spread': '0.3662', 'groupId': 'OG003'}]}]}, {'title': 'Week 4, n=50, 51, 51, 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.083', 'spread': '0.5870', 'groupId': 'OG000'}, {'value': '-2.082', 'spread': '0.5480', 'groupId': 'OG001'}, {'value': '-2.142', 'spread': '0.5092', 'groupId': 'OG002'}, {'value': '-2.305', 'spread': '0.4554', 'groupId': 'OG003'}]}]}, {'title': 'Week 8, n=49, 51, 49, 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.308', 'spread': '0.6989', 'groupId': 'OG000'}, {'value': '-2.262', 'spread': '0.7152', 'groupId': 'OG001'}, {'value': '-2.334', 'spread': '0.6046', 'groupId': 'OG002'}, {'value': '-2.516', 'spread': '0.6408', 'groupId': 'OG003'}]}]}, {'title': 'Week 12, n=49, 50, 47, 47', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.372', 'spread': '0.8215', 'groupId': 'OG000'}, {'value': '-2.351', 'spread': '0.7622', 'groupId': 'OG001'}, {'value': '-2.441', 'spread': '0.6372', 'groupId': 'OG002'}, {'value': '-2.730', 'spread': '0.6254', 'groupId': 'OG003'}]}]}, {'title': 'Week 16, n=47, 50, 46, 46', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.502', 'spread': '0.8650', 'groupId': 'OG000'}, {'value': '-2.432', 'spread': '0.7991', 'groupId': 'OG001'}, {'value': '-2.513', 'spread': '0.6429', 'groupId': 'OG002'}, {'value': '-2.862', 'spread': '0.6903', 'groupId': 'OG003'}]}]}, {'title': 'Week 24, n=46, 47, 45, 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.506', 'spread': '0.8094', 'groupId': 'OG000'}, {'value': '-2.557', 'spread': '0.7956', 'groupId': 'OG001'}, {'value': '-2.505', 'spread': '0.7284', 'groupId': 'OG002'}, {'value': '-2.919', 'spread': '0.7584', 'groupId': 'OG003'}]}]}, {'title': 'Week 32, n=44, 42, 42, 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.497', 'spread': '0.8045', 'groupId': 'OG000'}, {'value': '-2.642', 'spread': '0.7408', 'groupId': 'OG001'}, {'value': '-2.528', 'spread': '0.7392', 'groupId': 'OG002'}, {'value': '-2.920', 'spread': '0.7488', 'groupId': 'OG003'}]}]}, {'title': 'Week 40, n=40, 42, 41, 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.605', 'spread': '0.7096', 'groupId': 'OG000'}, {'value': '-2.640', 'spread': '0.7391', 'groupId': 'OG001'}, {'value': '-2.581', 'spread': '0.6803', 'groupId': 'OG002'}, {'value': '-2.949', 'spread': '0.7665', 'groupId': 'OG003'}]}]}, {'title': 'Week 48, n=40, 42, 40, 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.650', 'spread': '0.6824', 'groupId': 'OG000'}, {'value': '-2.649', 'spread': '0.7388', 'groupId': 'OG001'}, {'value': '-2.557', 'spread': '0.6711', 'groupId': 'OG002'}, {'value': '-2.935', 'spread': '0.7415', 'groupId': 'OG003'}]}]}, {'title': 'Week 60; n=22, 24, 19, 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.705', 'spread': '0.6379', 'groupId': 'OG000'}, {'value': '-2.810', 'spread': '0.5765', 'groupId': 'OG001'}, {'value': '-2.703', 'spread': '0.7455', 'groupId': 'OG002'}, {'value': '-2.906', 'spread': '0.5646', 'groupId': 'OG003'}]}]}, {'title': 'Week 72; n=5, 5, 5, 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.586', 'spread': '0.4682', 'groupId': 'OG000'}, {'value': '-2.733', 'spread': '0.6809', 'groupId': 'OG001'}, {'value': '-2.725', 'spread': '0.5025', 'groupId': 'OG002'}, {'value': '-2.780', 'spread': '0.6598', 'groupId': 'OG003'}]}]}, {'title': 'Week 84; n= 2, 1, 2, 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.993', 'spread': '3.4142', 'groupId': 'OG000'}, {'value': '-3.032', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated as only one participant was analyzed.', 'groupId': 'OG001'}, {'value': '-3.155', 'spread': '0.1218', 'groupId': 'OG002'}, {'value': '-3.257', 'spread': '0.5700', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'Blood samples were collected for analysis of HIV-1 RNA. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in plasma HIV-1 RNA (log10) is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.', 'unitOfMeasure': 'Log 10 c/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population (observed)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-955176/GSK3532795 60 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label tenofovir/emtricitabine (TDF/FTC) 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG001', 'title': 'BMS-955176/GSK3532795 120 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.'}, {'id': 'OG002', 'title': 'BMS-955176/GSK3532795 180 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG003', 'title': 'EFV 600 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}], 'classes': [{'title': 'Week 4, n=50, 51, 50, 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '41.6', 'spread': '148.92', 'groupId': 'OG000'}, {'value': '72.9', 'spread': '167.53', 'groupId': 'OG001'}, {'value': '52.9', 'spread': '149.54', 'groupId': 'OG002'}, {'value': '64.7', 'spread': '145.51', 'groupId': 'OG003'}]}]}, {'title': 'Week 8, n=48, 49, 49, 47', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '59.1', 'spread': '219.64', 'groupId': 'OG000'}, {'value': '81.8', 'spread': '126.79', 'groupId': 'OG001'}, {'value': '88.4', 'spread': '177.68', 'groupId': 'OG002'}, {'value': '117.4', 'spread': '230.74', 'groupId': 'OG003'}]}]}, {'title': 'Week 12, n=49, 49, 47, 47', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '110.4', 'spread': '170.87', 'groupId': 'OG000'}, {'value': '120.0', 'spread': '178.04', 'groupId': 'OG001'}, {'value': '129.7', 'spread': '175.73', 'groupId': 'OG002'}, {'value': '142.5', 'spread': '118.39', 'groupId': 'OG003'}]}]}, {'title': 'Week 16, n=46, 50, 46, 46', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90.8', 'spread': '200.76', 'groupId': 'OG000'}, {'value': '99.7', 'spread': '171.16', 'groupId': 'OG001'}, {'value': '128.0', 'spread': '212.09', 'groupId': 'OG002'}, {'value': '140.5', 'spread': '179.70', 'groupId': 'OG003'}]}]}, {'title': 'Week 24, n=46, 46, 44, 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '94.3', 'spread': '175.00', 'groupId': 'OG000'}, {'value': '81.2', 'spread': '195.39', 'groupId': 'OG001'}, {'value': '92.5', 'spread': '144.04', 'groupId': 'OG002'}, {'value': '134.7', 'spread': '151.70', 'groupId': 'OG003'}]}]}, {'title': 'Week 32, n=44, 42, 42, 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '131.5', 'spread': '207.69', 'groupId': 'OG000'}, {'value': '103.5', 'spread': '172.15', 'groupId': 'OG001'}, {'value': '99.7', 'spread': '171.95', 'groupId': 'OG002'}, {'value': '175.6', 'spread': '152.48', 'groupId': 'OG003'}]}]}, {'title': 'Week 40, n=41, 42, 41, 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '175.9', 'spread': '235.99', 'groupId': 'OG000'}, {'value': '194.4', 'spread': '235.14', 'groupId': 'OG001'}, {'value': '167.3', 'spread': '215.23', 'groupId': 'OG002'}, {'value': '222.5', 'spread': '191.99', 'groupId': 'OG003'}]}]}, {'title': 'Week 48, n=40, 41, 39, 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '158.3', 'spread': '228.90', 'groupId': 'OG000'}, {'value': '152.0', 'spread': '204.56', 'groupId': 'OG001'}, {'value': '161.4', 'spread': '221.65', 'groupId': 'OG002'}, {'value': '232.4', 'spread': '207.71', 'groupId': 'OG003'}]}]}, {'title': 'Week 60; n=22, 23, 19, 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '168.4', 'spread': '148.63', 'groupId': 'OG000'}, {'value': '156.5', 'spread': '301.91', 'groupId': 'OG001'}, {'value': '198.3', 'spread': '137.51', 'groupId': 'OG002'}, {'value': '204.7', 'spread': '154.86', 'groupId': 'OG003'}]}]}, {'title': 'Week 72; n=5, 5, 5, 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '176.2', 'spread': '98.50', 'groupId': 'OG000'}, {'value': '336.8', 'spread': '329.32', 'groupId': 'OG001'}, {'value': '240.4', 'spread': '240.48', 'groupId': 'OG002'}, {'value': '209.7', 'spread': '97.79', 'groupId': 'OG003'}]}]}, {'title': 'Week 84; n=2, 1, 2, 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'spread': '173.95', 'groupId': 'OG000'}, {'value': '203.0', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated as only one participant was analyzed.', 'groupId': 'OG001'}, {'value': '97.0', 'spread': '285.67', 'groupId': 'OG002'}, {'value': '165.5', 'spread': '70.00', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'CD4+ T-cell counts was assessed using flow cytometry. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in CD4+T- cell counts is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.', 'unitOfMeasure': 'Cells per microliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population (observed)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Percentage of CD4+ T-cells Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-955176/GSK3532795 60 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label tenofovir/emtricitabine (TDF/FTC) 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG001', 'title': 'BMS-955176/GSK3532795 120 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.'}, {'id': 'OG002', 'title': 'BMS-955176/GSK3532795 180 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG003', 'title': 'EFV 600 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}], 'classes': [{'title': 'Week 4, n=50, 51, 50, 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.56', 'spread': '3.195', 'groupId': 'OG000'}, {'value': '3.43', 'spread': '3.982', 'groupId': 'OG001'}, {'value': '3.93', 'spread': '3.210', 'groupId': 'OG002'}, {'value': '3.87', 'spread': '4.284', 'groupId': 'OG003'}]}]}, {'title': 'Week 8, n=48, 49, 49, 47', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.02', 'spread': '4.650', 'groupId': 'OG000'}, {'value': '4.15', 'spread': '4.047', 'groupId': 'OG001'}, {'value': '5.15', 'spread': '3.943', 'groupId': 'OG002'}, {'value': '5.09', 'spread': '4.257', 'groupId': 'OG003'}]}]}, {'title': 'Week 12, n=49, 49, 47, 47', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.47', 'spread': '4.570', 'groupId': 'OG000'}, {'value': '5.39', 'spread': '4.577', 'groupId': 'OG001'}, {'value': '6.22', 'spread': '4.450', 'groupId': 'OG002'}, {'value': '6.29', 'spread': '4.557', 'groupId': 'OG003'}]}]}, {'title': 'Week 16, n=46, 50, 46, 46', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.20', 'spread': '6.163', 'groupId': 'OG000'}, {'value': '5.65', 'spread': '4.179', 'groupId': 'OG001'}, {'value': '6.95', 'spread': '4.019', 'groupId': 'OG002'}, {'value': '6.87', 'spread': '4.763', 'groupId': 'OG003'}]}]}, {'title': 'Week 24, n=46, 46, 44, 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.68', 'spread': '5.834', 'groupId': 'OG000'}, {'value': '5.71', 'spread': '4.542', 'groupId': 'OG001'}, {'value': '6.96', 'spread': '4.761', 'groupId': 'OG002'}, {'value': '5.94', 'spread': '5.730', 'groupId': 'OG003'}]}]}, {'title': 'Week 32, n=44, 42, 42, 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.75', 'spread': '6.559', 'groupId': 'OG000'}, {'value': '7.36', 'spread': '5.457', 'groupId': 'OG001'}, {'value': '6.90', 'spread': '6.498', 'groupId': 'OG002'}, {'value': '8.37', 'spread': '6.253', 'groupId': 'OG003'}]}]}, {'title': 'Week 40, n=41, 42, 41, 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.90', 'spread': '6.612', 'groupId': 'OG000'}, {'value': '6.97', 'spread': '8.253', 'groupId': 'OG001'}, {'value': '7.94', 'spread': '5.601', 'groupId': 'OG002'}, {'value': '9.06', 'spread': '5.538', 'groupId': 'OG003'}]}]}, {'title': 'Week 48, n=40, 41, 39, 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.07', 'spread': '6.311', 'groupId': 'OG000'}, {'value': '7.62', 'spread': '6.218', 'groupId': 'OG001'}, {'value': '9.59', 'spread': '4.828', 'groupId': 'OG002'}, {'value': '10.16', 'spread': '6.262', 'groupId': 'OG003'}]}]}, {'title': 'Week 60; n=22, 23, 19, 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.41', 'spread': '6.290', 'groupId': 'OG000'}, {'value': '8.44', 'spread': '7.788', 'groupId': 'OG001'}, {'value': '11.36', 'spread': '6.568', 'groupId': 'OG002'}, {'value': '10.73', 'spread': '7.098', 'groupId': 'OG003'}]}]}, {'title': 'Week 72; n=5, 5, 5, 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.56', 'spread': '3.436', 'groupId': 'OG000'}, {'value': '9.92', 'spread': '4.147', 'groupId': 'OG001'}, {'value': '12.46', 'spread': '9.557', 'groupId': 'OG002'}, {'value': '9.67', 'spread': '3.982', 'groupId': 'OG003'}]}]}, {'title': 'Week 84; n=2, 1, 2, 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.75', 'spread': '8.839', 'groupId': 'OG000'}, {'value': '4.60', 'spread': 'NA', 'comment': 'Standard deviation could not be analyzed as only one participant was analyzed.', 'groupId': 'OG001'}, {'value': '19.50', 'spread': '11.314', 'groupId': 'OG002'}, {'value': '12.90', 'spread': '4.950', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'CD4+ T-cell counts overall was assessed using flow cytometry. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in percentage of CD4+T- cell counts is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.', 'unitOfMeasure': 'Percentage of CD4+T- cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population (observed)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation (AELD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-955176/GSK3532795 60 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label tenofovir/emtricitabine (TDF/FTC) 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG001', 'title': 'BMS-955176/GSK3532795 120 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.'}, {'id': 'OG002', 'title': 'BMS-955176/GSK3532795 180 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG003', 'title': 'EFV 600 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}], 'classes': [{'title': 'SAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'AELD', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 96', 'description': 'Any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention were categorized as SAE. Number of participants with SAEs and AELDs is summarized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Centers for Disease Control (CDC) Class C Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-955176/GSK3532795 60 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label tenofovir/emtricitabine (TDF/FTC) 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG001', 'title': 'BMS-955176/GSK3532795 120 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.'}, {'id': 'OG002', 'title': 'BMS-955176/GSK3532795 180 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG003', 'title': 'EFV 600 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 96', 'description': 'The occurrence of new AIDS defining events that is CDC class C events is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax), Observed Pre-dose Plasma Concentration (C0) and Observed Plasma Concentration at the End of a Dosing Interval (Ctau) of BMS-955176/GSK3532795', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-955176/GSK3532795 60 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label tenofovir/emtricitabine (TDF/FTC) 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG001', 'title': 'BMS-955176/GSK3532795 120 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.'}, {'id': 'OG002', 'title': 'BMS-955176/GSK3532795 180 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}], 'classes': [{'title': 'Cmax', 'categories': [{'measurements': [{'value': '1945.342', 'spread': '16.0', 'groupId': 'OG000'}, {'value': '3162.161', 'spread': '28.8', 'groupId': 'OG001'}, {'value': '4645.266', 'spread': '16.2', 'groupId': 'OG002'}]}]}, {'title': 'C0', 'categories': [{'measurements': [{'value': '1065.102', 'spread': '25.2', 'groupId': 'OG000'}, {'value': '1800.952', 'spread': '33.4', 'groupId': 'OG001'}, {'value': '2728.671', 'spread': '17.8', 'groupId': 'OG002'}]}]}, {'title': 'Ctau', 'categories': [{'measurements': [{'value': '1100.138', 'spread': '15.1', 'groupId': 'OG000'}, {'value': '1656.578', 'spread': '39.7', 'groupId': 'OG001'}, {'value': '2705.751', 'spread': '26.8', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)', 'description': 'Serial blood samples were collected at indicated time points for intensive pharmacokinetic (PK) assessment. The PK assessments were performed on evaluable PK Population, a sub-population which included all treated participants who had adequate PK profiles.', 'unitOfMeasure': 'Nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable PK Population'}, {'type': 'SECONDARY', 'title': 'Time of Maximum Observed Plasma Concentration (Tmax) of BMS-955176/GSK3532795', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-955176/GSK3532795 60 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label tenofovir/emtricitabine (TDF/FTC) 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG001', 'title': 'BMS-955176/GSK3532795 120 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.'}, {'id': 'OG002', 'title': 'BMS-955176/GSK3532795 180 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '8.2'}, {'value': '4.29', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '5.1'}, {'value': '5.50', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '12.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose (morning) and 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)', 'description': 'Serial blood samples were collected at indicated time points for intensive PK assessment.', 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable PK Population'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve in One Dosing Interval (AUC [Tau]) of BMS-955176/GSK3532795', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-955176/GSK3532795 60 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label tenofovir/emtricitabine (TDF/FTC) 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'OG001', 'title': 'BMS-955176/GSK3532795 120 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.'}, {'id': 'OG002', 'title': 'BMS-955176/GSK3532795 180 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}], 'classes': [{'categories': [{'measurements': [{'value': '34226.751', 'spread': '18.73', 'groupId': 'OG000'}, {'value': '55251.956', 'spread': '32.88', 'groupId': 'OG001'}, {'value': '87128.359', 'spread': '20.79', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)', 'description': 'Serial blood samples were collected at indicated time points for intensive PK assessment.', 'unitOfMeasure': 'Hour*nanogram/ milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable PK Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BMS-955176/GSK3532795 60 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label tenofovir/emtricitabine (TDF/FTC) 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'FG001', 'title': 'BMS-955176/GSK3532795 120 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.'}, {'id': 'FG002', 'title': 'BMS-955176/GSK3532795 180 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'FG003', 'title': 'EFV 600 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '53'}]}], 'dropWithdraws': [{'type': 'Administrative reason by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '39'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Poor/Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Reached stopping criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was originally designed for 96 weeks of treatment in treatment naïve human immunodeficiency virus-1 (HIV-1) infected adults; however, it was terminated early due to gastrointestinal intolerability and treatment emergent resistance. The study was conducted at 58 centers in 12 countries.', 'preAssignmentDetails': 'A total of 305 participants were screened, of which 210 were randomized to 1 of 4 treatment arms. Of 210 participants, only 206 received study treatment. Four participants were randomized but not treated as: 2 participants were randomized in error, 1 participant was lost to follow-up and 1 participant withdrew consent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '206', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'BMS-955176/GSK3532795 60 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'BG001', 'title': 'BMS-955176/GSK3532795 120 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.'}, {'id': 'BG002', 'title': 'BMS-955176/GSK3532795 180 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'BG003', 'title': 'EFV 600 mg + TDF/FTC', 'description': 'Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'spread': '8.26', 'groupId': 'BG000'}, {'value': '34.7', 'spread': '11.29', 'groupId': 'BG001'}, {'value': '35.5', 'spread': '11.34', 'groupId': 'BG002'}, {'value': '32.9', 'spread': '9.35', 'groupId': 'BG003'}, {'value': '33.7', 'spread': '10.18', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Treated Subjects Population, also known as the modified intent-to-treat (mITT) population, comprised of all subjects who received at least one dose of study treatment, was used to present baseline characteristics'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '176', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race customized', 'categories': [{'title': 'White', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '158', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Unknown', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics is presented for Treated Subjects Population, also known as the modified intent-to-treat (mITT) Population which comprised of all participants who received at least one dose of BMS-955176 or EFV.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'whyStopped': 'The trial ended early due to GI intolerability and treatment-emergent resistance.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-20', 'studyFirstSubmitDate': '2015-03-11', 'resultsFirstSubmitDate': '2018-08-20', 'studyFirstSubmitQcDate': '2015-04-09', 'lastUpdatePostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-20', 'studyFirstPostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <40 Copies Per Milliliter (c/mL) at Week 24 Using Food and Drug Administration (FDA) Snapshot Algorithm', 'timeFrame': 'Week 24', 'description': 'Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV 1 RNA \\<40 c/mL at Week 24 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window (18 to 30 weeks) to determine response. Analysis was performed on mITT Population, which comprised of randomized participants who received at least 1 dose of BMS-955176/GSK3532795 or EFV.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Plasma HIV-1 RNA < 40 c/mL at Weeks 48 and 96 Using FDA Snapshot Algorithm', 'timeFrame': 'Weeks 48 and 96', 'description': 'Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV 1 RNA \\<40 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response. The analysis was performed using mITT Population (observed), which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). The data was not collected for Week 96 analysis; as the study was terminated early. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).'}, {'measure': 'Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Week 24 Using FDA Snapshot Algorithm', 'timeFrame': 'Week 24', 'description': 'Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV-1 RNA \\<200 c/mL at Week 24 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response.'}, {'measure': 'Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Weeks 48 and 96', 'timeFrame': 'Weeks 48 and 96', 'description': 'Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV-1 RNA \\<200 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response. The analysis was performed using mITT Population (observed), which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). The data was not collected for Week 96 analysis; as the study was terminated early. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).'}, {'measure': 'Number of Participants With Newly Emergent Genotypic Resistance Using All On-treatment Isolates', 'timeFrame': 'Week 24', 'description': 'The emergence of genotypic resistance among samples selected for drug resistance testing were assessed by searching for all reverse transcriptase substitutions and protease inhibitor substitutions listed in the International Acquired Immunodeficiency Syndrome (AIDS) Society-United States of America (IAS-USA) list of HIV-1 drug resistance mutations. The outcome was originally designed to be assessed up to 96 weeks of treatment, but it was analyzed up to Week 24 as the study was terminated early. The emergence of genotypic resistance is presented for participants in the mITT Population who had Baseline and on-treatment genotypic resistance testing and who had successful sequencing.'}, {'measure': 'Number of Participants With Newly Emergent Phenotypic Resistance Using All On-treatment Isolates', 'timeFrame': 'Week 24', 'description': 'Phenotypic resistance to a drug is defined as a fold change (i.e., ratio of the 50% inhibitory concentration (IC50) of the clinical isolate to the IC50 of the reference strain) which is greater than the cut-off for reduced susceptibility. Emergent phenotypic resistance to BMS-955176/GSK3532795 was defined as a Baseline fold change IC50\\<= 3 and an on-treatment fold change IC50\\>3. The number of participants with newly emergent phenotypic resistance is presented for participants in the mITT Population who had Baseline and on-treatment phenotypic resistance testing. The outcome was originally designed to be assessed up to 96 weeks of treatment, but it was analyzed up to Week 24 as the study was terminated early.'}, {'measure': 'Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time', 'timeFrame': 'Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'Blood samples were collected for analysis of HIV-1 RNA. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in plasma HIV-1 RNA (log10) is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.'}, {'measure': 'Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'CD4+ T-cell counts was assessed using flow cytometry. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in CD4+T- cell counts is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.'}, {'measure': 'Change From Baseline in the Percentage of CD4+ T-cells Over Time', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'CD4+ T-cell counts overall was assessed using flow cytometry. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in percentage of CD4+T- cell counts is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation (AELD)', 'timeFrame': 'Up to Week 96', 'description': 'Any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention were categorized as SAE. Number of participants with SAEs and AELDs is summarized.'}, {'measure': 'Number of Participants With at Least One Centers for Disease Control (CDC) Class C Events', 'timeFrame': 'Up to Week 96', 'description': 'The occurrence of new AIDS defining events that is CDC class C events is presented.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax), Observed Pre-dose Plasma Concentration (C0) and Observed Plasma Concentration at the End of a Dosing Interval (Ctau) of BMS-955176/GSK3532795', 'timeFrame': 'Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)', 'description': 'Serial blood samples were collected at indicated time points for intensive pharmacokinetic (PK) assessment. The PK assessments were performed on evaluable PK Population, a sub-population which included all treated participants who had adequate PK profiles.'}, {'measure': 'Time of Maximum Observed Plasma Concentration (Tmax) of BMS-955176/GSK3532795', 'timeFrame': 'Pre-dose (morning) and 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)', 'description': 'Serial blood samples were collected at indicated time points for intensive PK assessment.'}, {'measure': 'Area Under the Concentration-time Curve in One Dosing Interval (AUC [Tau]) of BMS-955176/GSK3532795', 'timeFrame': 'Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)', 'description': 'Serial blood samples were collected at indicated time points for intensive PK assessment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infection, Human Immunodeficiency Virus']}, 'referencesModule': {'references': [{'pmid': '30352054', 'type': 'DERIVED', 'citation': 'Morales-Ramirez J, Bogner JR, Molina JM, Lombaard J, Dicker IB, Stock DA, DeGrosky M, Gartland M, Pene Dumitrescu T, Min S, Llamoso C, Joshi SR, Lataillade M. Safety, efficacy, and dose response of the maturation inhibitor GSK3532795 (formerly known as BMS-955176) plus tenofovir/emtricitabine once daily in treatment-naive HIV-1-infected adults: Week 24 primary analysis from a randomized Phase IIb trial. PLoS One. 2018 Oct 23;13(10):e0205368. doi: 10.1371/journal.pone.0205368. eCollection 2018.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find at least one dose of BMS-955176 that will be safe, effective and tolerable for HIV-1 infected treatment naive adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.\n\nInclusion Criteria:\n\n* Men and non-pregnant women, at least 18 years of age\n* Antiretroviral treatment-naïve; defined as no current or previous exposure to \\> 1 week of an antiretroviral drug\n* Plasma HIV-1 RNA ≥ 1000 copies/mL\n* CD4 T-cell count \\> 200 cells/mm3\n\nExclusion Criteria:\n\n* Resistance or partial resistance to any study drug determined by tests at Screening\n* Current or historical genotypic and/or phenotypic drug resistance testing showing certain resistance mutations to EFV, TDF, FTC, Protease Inhibitors\n* Chronic hepatitis B virus (HBV)/ hepatitis C virus (HCV)\n* Blood tests that indicate normal liver function\n* Hemoglobin \\< 8.0 g/dL, platelets \\< 50,000 cells/mm3'}, 'identificationModule': {'nctId': 'NCT02415595', 'briefTitle': 'Dose-finding Study of BMS-955176 to Treat HIV-1 Infected Treatment-naive Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'A Phase 2b Randomized, Active-Controlled, Double-Blind Trial to Investigate Safety, Efficacy, and Dose-response of BMS-955176, Given on a Backbone of Tenofovir/Emtricitabine, in Treatment-Naive HIV-1 Infected Adults', 'orgStudyIdInfo': {'id': '205891'}, 'secondaryIdInfos': [{'id': '2013-005487-26', 'type': 'EUDRACT_NUMBER'}, {'id': 'AI468-038', 'type': 'OTHER', 'domain': 'Bristol-Myers Squibb'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: BMS-955176 60 mg + TDF/FTC', 'description': 'BMS-955176 at 60 mg active dose per day + BMS-955176 placebo matching 120 mg + efavirenz (EFV) placebo matching 600 mg + tenofovir/emtricitabine (TDF/FTC) 300/200 mg per day, orally', 'interventionNames': ['Drug: BMS-955176', 'Drug: TDF/FTC']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: BMS-955176 120 mg + TDF/FTC', 'description': 'BMS-955176 placebo matching 60 mg + BMS-955176 at 120mg active dose per day + EFV placebo matching 600mg + TDF/FTC 300/200mg per day, orally', 'interventionNames': ['Drug: BMS-955176', 'Drug: TDF/FTC']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: BMS-955176 180 mg + TDF/FTC', 'description': 'BMS-955176 at 60mg active dose per day + BMS-955176 at 120mg active dose per day + EFV placebo matching 600mg + TDF/FTC at 300/200mg per day, orally', 'interventionNames': ['Drug: BMS-955176', 'Drug: TDF/FTC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 4: EFV + TDF/FTC', 'description': 'BMS-955176 placebo matching 60mg + BMS-955176 placebo matching 120mg + EFV at 600mg per day + TDF/FTC 300/200mg per day', 'interventionNames': ['Drug: EFV', 'Drug: TDF/FTC']}], 'interventions': [{'name': 'BMS-955176', 'type': 'DRUG', 'description': 'HIV Maturation Inhibitor', 'armGroupLabels': ['Arm 1: BMS-955176 60 mg + TDF/FTC', 'Arm 2: BMS-955176 120 mg + TDF/FTC', 'Arm 3: BMS-955176 180 mg + TDF/FTC']}, {'name': 'EFV', 'type': 'DRUG', 'description': 'EFV', 'armGroupLabels': ['Arm 4: EFV + TDF/FTC']}, {'name': 'TDF/FTC', 'type': 'DRUG', 'description': 'TDF/FTC', 'armGroupLabels': ['Arm 1: BMS-955176 60 mg + TDF/FTC', 'Arm 2: BMS-955176 120 mg + TDF/FTC', 'Arm 3: BMS-955176 180 mg + TDF/FTC', 'Arm 4: EFV + TDF/FTC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90211', 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