Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-02-26 @ 11:54 PM
Study NCT ID:
NCT02362503
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-22
First Post:
2015-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C576364', 'term': 'fostemsavir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'ViiV Healthcare'}, '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': 'On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.', 'description': 'Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.', 'eventGroups': [{'id': 'EG000', 'title': 'Randomized Cohort-Placebo', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 16, 'seriousNumAtRisk': 69, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Randomized Cohort-fostemsavir 600 mg BID', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.', 'otherNumAtRisk': 203, 'deathsNumAtRisk': 203, 'otherNumAffected': 45, 'seriousNumAtRisk': 203, 'deathsNumAffected': 10, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Non-randomized Cohort-fostemsavir 600 mg BID', 'description': 'This reporting group includes HTE HIV-1 infected participants who were assigned to the Non-randomized Cohort and received fostemsavir 600 mg BID and OBT. Non-randomized Cohort participants are assigned based on their screening status of having no remaining classes of fully active antiretroviral that can combined in a new drug regimen. The data reported are safety events during fostemsavir dosing until the Week 96 data cut-off date.', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 92, 'seriousNumAtRisk': 99, 'deathsNumAffected': 17, 'seriousNumAffected': 48}, {'id': 'EG003', 'title': 'Randomized Cohort-Total', 'description': 'This reporting group includes all participants in the Randomized Cohort. The data reported are safety events during fostemsavir dosing until the Week 96 data cut-off date.', 'otherNumAtRisk': 271, 'deathsNumAtRisk': 271, 'otherNumAffected': 214, 'seriousNumAtRisk': 271, 'deathsNumAffected': 12, 'seriousNumAffected': 92}, {'id': 'EG004', 'title': 'Total Fostemsavir', 'description': 'This reporting group included all enrolled participants (Randomized Cohort and Non-randomized Cohort) and who received fostemsavir 600 mg during the open-label period. The data reported are safety events during fostemsavir dosing until the Week 96 data cut-off date.', 'otherNumAtRisk': 370, 'deathsNumAtRisk': 370, 'otherNumAffected': 306, 'seriousNumAtRisk': 370, 'deathsNumAffected': 29, 'seriousNumAffected': 140}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 48, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 84, 'numAffected': 60}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 132, 'numAffected': 85}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 31, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 65, 'numAffected': 45}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 96, 'numAffected': 66}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 21, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 64, 'numAffected': 42}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 85, 'numAffected': 57}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 24, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 50, 'numAffected': 34}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 74, 'numAffected': 53}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 53, 'numAffected': 36}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 66, 'numAffected': 48}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 24, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 42, 'numAffected': 30}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 66, 'numAffected': 46}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 45, 'numAffected': 33}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 57, 'numAffected': 44}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 45, 'numAffected': 34}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 52, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 31, 'numAffected': 26}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 46, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 48, 'numAffected': 29}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 61, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 35, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 29, 'numAffected': 22}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 42, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 35, 'numAffected': 31}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 30, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 32, 'numAffected': 28}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 30, 'numAffected': 22}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 35, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 34, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 31, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 27, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 23, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 23, 'numAffected': 21}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 23, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anogenital warts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 22, 'numAffected': 17}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 21, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skin papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tuberculosis liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cachexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 370, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Logarithm to the Base 10 (log10) HIV-1 Ribonucleic Acid (RNA) From Day 1 at Day 8-Randomized Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort-Placebo', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).'}, {'id': 'OG001', 'title': 'Randomized Cohort-fostemsavir 600 mg BID', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.166', 'groupId': 'OG000', 'lowerLimit': '-0.326', 'upperLimit': '-0.007'}, {'value': '-0.791', 'groupId': 'OG001', 'lowerLimit': '-0.885', 'upperLimit': '-0.698'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.625', 'ciLowerLimit': '-0.810', 'ciUpperLimit': '-0.441', 'pValueComment': 'Hypothesis test:µfostemsavir=µPlacebo where µ is a common intercept.', 'estimateComment': 'Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 and Day 8', 'description': 'Plasma samples were collected for analysis of HIV-1 RNA. Mean change in log10 HIV-1 RNA from Day 1 was estimated using analysis of covariance (ANCOVA) with log10 HIV-1 RNA change from Day 1 at Day 8 as dependent variable, treatment (fostemsavir or placebo) as an independent variable, and Day 1 log10 HIV-1 RNA as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. The analysis was performed on Intent-to-Treat Exposed (ITT-E) Population which comprised of all randomized participants who received at least one dose of study treatment. Missing HIV-1 RNA values at Day 8 were imputed using (a) Day 1 Observation Carried Forward (D1OCF) for participants without a value during blinded treatment (i.e, imputing a zero change from Day 1) or (b) Last Observation Carried Forward (LOCF) for participants with an early value during blinded treatment before the Day 8 analysis visit window.', 'unitOfMeasure': 'Log10 copies per milliliter (c/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Participants with missing Day 1 HIV-1 RNA values were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA Decreases From Day 1 That Exceed 0.5 log10 c/mL and 1.0 log10 c/mL at Day 8-Randomized Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort-Placebo', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).'}, {'id': 'OG001', 'title': 'Randomized Cohort-fostemsavir 600 mg BID', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.'}], 'classes': [{'title': '>0.5 log10 c/mL', 'categories': [{'measurements': [{'value': '18.84', 'groupId': 'OG000', 'lowerLimit': '11.35', 'upperLimit': '29.61'}, {'value': '64.53', 'groupId': 'OG001', 'lowerLimit': '57.74', 'upperLimit': '70.79'}]}]}, {'title': '>1.0 log10 c/mL', 'categories': [{'measurements': [{'value': '10.14', 'groupId': 'OG000', 'lowerLimit': '5.00', 'upperLimit': '19.49'}, {'value': '45.81', 'groupId': 'OG001', 'lowerLimit': '39.10', 'upperLimit': '52.68'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '45.69', 'ciLowerLimit': '32.95', 'ciUpperLimit': '55.45', 'estimateComment': 'Difference between treatment groups (fostemsavir 600 mg BID-Placebo) and 95% confidence interval using Newcombe method is presented for \\>0.5 log10 c/mL.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.67', 'ciLowerLimit': '24.16', 'ciUpperLimit': '44.25', 'estimateComment': 'Difference between treatment groups (fostemsavir 600 mg BID-Placebo) and 95% confidence interval using Newcombe method is presented for \\>1.0 log10 c/mL.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 and Day 8', 'description': 'The percentage of participants in the Randomized Cohort with HIV-1 RNA decreases from Day 1 that exceed 0.5 log10 c/mL and 1.0 log10 c/mL at Day 8 was determined by comparing HIV-1 RNA Day 1 measurement of each participant to their Day 8 measurement. This was an ITT analysis that classified participants without HIV-1 RNA at Day 1 or Day 8 as failures. The percentage of responders along with 95% confidence interval based on Wilson score is presented.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA <40 c/mL at Weeks 24, 48 and 96-Randomized Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants were randomized to receive fostemsavir 600 mg BID or placebo along with their current failing antiretroviral regimen during the double-blind period for 8 days. During the open-label period, all participants received open-label fostemsavir 600 mg BID in combination with OBT for at least 96 weeks.'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000', 'lowerLimit': '47.0', 'upperLimit': '58.8'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000', 'lowerLimit': '47.7', 'upperLimit': '59.5'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '54.0', 'upperLimit': '65.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Weeks 24, 48 and 96', 'description': 'The durability of response (that is, the number of participants achieving HIV-1 RNA \\<40 c/mL) at Weeks 24, 48 and 96 of open-label fostemsavir plus OBT in the Randomized Cohort was assessed using the Food and Drug Administration (FDA) snapshot algorithm in which participants without HIV-1 RNA at Weeks 24, 48 and 96 or those who changed OBT due to lack of efficacy through Weeks 24, 48 and 96 were counted as failures. The percentage of participants in the Randomized Cohort who achieved virologic success (HIV-1 RNA \\<40 c/mL) at Weeks 24, 48 and 96 is presented along with 95% Wilson confidence interval. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With On-treatment Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Randomized Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants were randomized to receive fostemsavir 600 mg BID or placebo along with their current failing antiretroviral regimen during the double-blind period for 8 days. During the open-label period, all participants received open-label fostemsavir 600 mg BID in combination with OBT for at least 96 weeks.'}], 'classes': [{'title': 'SAE', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}, {'title': 'AELD', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 96 analysis cut-off date', 'description': 'An SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or causes prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; an important medical event that may jeopardize the participant or require intervention. Number of participants with on-treatment SAEs and AEs leading to withdrawal of study treatment is presented. SAEs and AELDs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants were randomized to receive fostemsavir 600 mg BID or placebo along with their current failing antiretroviral regimen during the double-blind period for 8 days. During the open-label period, all participants received open-label fostemsavir 600 mg BID in combination with OBT for at least 96 weeks.'}], 'classes': [{'title': 'Albumin; n=268', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase; n=268', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase; n=268', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Amylase; n=268', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase; n=268', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Bicarbonate; n=268', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Direct bilirubin; n=268', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin; n=268', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Calcium; n=268', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol; n=221', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Creatine kinase; n=268', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine; n=268', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Estimated creatinine clearance; n=268', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'Glucose/hyperglycemia; n=267', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Glucose/hypoglycemia; n=267', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Potassium/hyperkalemia; n=268', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Potassium/hypokalemia; n=268', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Low density lipoprotein (LDL) cholesterol; n=216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Lipase; n=268', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Sodium/hypernatremia; n=268', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Sodium/hyponatremia; n=268', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides; n=221', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Urate; n=268', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and up to Week 96 analysis cut-off date', 'description': 'Laboratory toxicities were graded for severity according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading system: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (potentially life-threatening). Baseline is defined as the latest pre-dose assessment. The number of participants with clinical chemistry toxicity grade increase to Grade 3-4 at anytime post-Baseline relative to Baseline is presented. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only participants with data available at the specified time points were analyzed (represented by n=X in category titles).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Toxicity Grade Increase in Hematology Results to Grade 3-4 Relative to Baseline-Randomized Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants were randomized to receive fostemsavir 600 mg BID or placebo along with their current failing antiretroviral regimen during the double-blind period for 8 days. During the open-label period, all participants received open-label fostemsavir 600 mg BID in combination with OBT for at least 96 weeks.'}], 'classes': [{'title': 'Hemoglobin; n=268', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils; n=268', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Platelets; n=267', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes; n=268', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and up to Week 96 analysis cut-off date', 'description': 'Laboratory toxicities were graded for severity according to the DAIDS grading system: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (potentially life-threatening). Baseline is defined as the latest pre-dose assessment. The number of participants with hematology toxicity grade increase to Grade 3-4 at anytime post-Baseline relative to Baseline is presented. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only participants with data available at the specified time points were analyzed (represented by n=X in category titles).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Centers for Disease Control (CDC) Class C Events-Randomized Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants were randomized to receive fostemsavir 600 mg BID or placebo along with their current failing antiretroviral regimen during the double-blind period for 8 days. During the open-label period, all participants received open-label fostemsavir 600 mg BID in combination with OBT for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 96 analysis cut-off date', 'description': 'Disease progression during open label fostemsavir plus OBT was assessed based on the occurrence of new AIDS defining events (CDC Class C events) or death. The number of participants with on-treatment CDC Class C AIDS events is presented. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Change From Day 1 in Cluster of Differentiation (CD) 4+ T-cell Count at Day 8-Randomized Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort-Placebo', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).'}, {'id': 'OG001', 'title': 'Randomized Cohort-fostemsavir 600 mg BID', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '33.0'}, {'value': '18.5', 'groupId': 'OG001', 'lowerLimit': '10.1', 'upperLimit': '26.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-16.8', 'ciUpperLimit': '16.0', 'estimateComment': 'Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 and Day 8', 'description': 'CD4+ T- cell counts were assessed by flow cytometry. Mean change in CD4+ T- cell count from Day 1 at Day 8 was analyzed using one-way ANCOVA with change of CD4+ cell counts from Day 1 at Day 8 as the dependent variable, treatment (fostemsavir or placebo) as an in-dependent variable, and Day 1 CD4+ cell count as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. Missing CD4+ cell count values at Day 8 were imputed using (a) D1OCF for participants without a value during blinded treatment (i.e., imputing a zero change from Day 1), or (b) LOCF for participants with an early value during blinded treatment before the Day 8 analysis visit window.', 'unitOfMeasure': 'Cells per cubic millimeter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in CD4+ T- Cell Count Percentage From Day 1 at Day 8-Randomized Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort-Placebo', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).'}, {'id': 'OG001', 'title': 'Randomized Cohort-fostemsavir 600 mg BID', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.243', 'groupId': 'OG000', 'lowerLimit': '-0.216', 'upperLimit': '0.703'}, {'value': '0.860', 'groupId': 'OG001', 'lowerLimit': '0.588', 'upperLimit': '1.133'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.617', 'ciLowerLimit': '0.082', 'ciUpperLimit': '1.151', 'estimateComment': 'Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 and Day 8', 'description': 'CD4+ T- cell counts were assessed by flow cytometry. Mean change in CD4+ T- cell count percentage from Day 1 at Day 8 was analyzed using one-way ANCOVA with change of CD4+ cell count percentage from Day 1 at Day 8 as the dependent variable, treatment (fostemsavir or placebo) as an independent variable, and Day 1 CD4+ cell count percentage as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. Missing CD4+ cell count values at Day 8 were imputed using (a) D1OCF for participants without a value during blinded treatment (ie, imputing a zero change from Day 1), or (b) LOCF for participants with an early value during blinded treatment before the Day 8 analysis visit window.', 'unitOfMeasure': 'Percentage of CD4+T- cells', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in log10 HIV-1 RNA for Fostemsavir When Given With OBT Through Week 96-Randomized Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants were randomized to receive fostemsavir 600 mg BID or placebo along with their current failing antiretroviral regimen during the double-blind period for 8 days. During the open-label period, all participants received open-label fostemsavir 600 mg BID in combination with OBT for at least 96 weeks.'}], 'classes': [{'title': 'Day 8; n=262', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.656', 'spread': '0.7536', 'groupId': 'OG000'}]}]}, {'title': 'Week 4; n=262', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.051', 'spread': '1.0717', 'groupId': 'OG000'}]}]}, {'title': 'Week 8; n=256', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.207', 'spread': '1.1416', 'groupId': 'OG000'}]}]}, {'title': 'Week 12; n=248', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.237', 'spread': '1.2105', 'groupId': 'OG000'}]}]}, {'title': 'Week 16; n=249', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.277', 'spread': '1.2834', 'groupId': 'OG000'}]}]}, {'title': 'Week 24; n=246', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.297', 'spread': '1.2788', 'groupId': 'OG000'}]}]}, {'title': 'Week 36; n=238', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.332', 'spread': '1.2265', 'groupId': 'OG000'}]}]}, {'title': 'Week 48; n=233', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.324', 'spread': '1.2876', 'groupId': 'OG000'}]}]}, {'title': 'Week 60; n=223', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.419', 'spread': '1.1973', 'groupId': 'OG000'}]}]}, {'title': 'Week 72; n=221', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.427', 'spread': '1.1542', 'groupId': 'OG000'}]}]}, {'title': 'Week 84; n=215', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.455', 'spread': '1.1930', 'groupId': 'OG000'}]}]}, {'title': 'Week 96; n=214', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.476', 'spread': '1.1984', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at Day 8, Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84 and 96', 'description': 'Blood samples were collected for the analysis of HIV-1 RNA. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as the value at post-dose visit minus the value at Baseline. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.', 'unitOfMeasure': 'Log10 c/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ T- Cell Count Through Week 96-Randomized Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants were randomized to receive fostemsavir 600 mg BID or placebo along with their current failing antiretroviral regimen during the double-blind period for 8 days. During the open-label period, all participants received open-label fostemsavir 600 mg BID in combination with OBT for at least 96 weeks.'}], 'classes': [{'title': 'Day 8; n=255', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.8', 'spread': '60.98', 'groupId': 'OG000'}]}]}, {'title': 'Week 4; n=259', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.9', 'spread': '131.75', 'groupId': 'OG000'}]}]}, {'title': 'Week 8; n=254', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61.5', 'spread': '113.47', 'groupId': 'OG000'}]}]}, {'title': 'Week 12; n=249', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.0', 'spread': '123.31', 'groupId': 'OG000'}]}]}, {'title': 'Week 16; n=245', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84.1', 'spread': '107.26', 'groupId': 'OG000'}]}]}, {'title': 'Week 24; n=247', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.4', 'spread': '112.10', 'groupId': 'OG000'}]}]}, {'title': 'Week 36; n=234', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '109.7', 'spread': '119.50', 'groupId': 'OG000'}]}]}, {'title': 'Week 48; n=228', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '138.9', 'spread': '135.06', 'groupId': 'OG000'}]}]}, {'title': 'Week 60; n=215', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '162.9', 'spread': '157.69', 'groupId': 'OG000'}]}]}, {'title': 'Week 72; n=217', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '172.1', 'spread': '184.81', 'groupId': 'OG000'}]}]}, {'title': 'Week 84; n=203', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '190.8', 'spread': '165.63', 'groupId': 'OG000'}]}]}, {'title': 'Week 96; n=213', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '204.7', 'spread': '191.28', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at Day 8, Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84 and 96', 'description': 'CD4+ T- cell counts were assessed by flow cytometry. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as the value at post-dose visit minus the value at Baseline.', 'unitOfMeasure': 'Cells per cubic millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ T- Cell Count Percentage Through Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants were randomized to receive fostemsavir 600 mg or placebo along with their current failing antiretroviral regimen during the double-blind period for 8 days. During the open-label period, all participants received open-label fostemsavir 600 mg BID in combination with OBT for at least 96 weeks'}], 'classes': [{'title': 'Day 8; n=255', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.75', 'spread': '1.970', 'groupId': 'OG000'}]}]}, {'title': 'Week 4; n=259', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.30', 'spread': '4.643', 'groupId': 'OG000'}]}]}, {'title': 'Week 8; n=254', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.36', 'spread': '4.392', 'groupId': 'OG000'}]}]}, {'title': 'Week 12; n=249', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.00', 'spread': '4.945', 'groupId': 'OG000'}]}]}, {'title': 'Week 16; n=245', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.51', 'spread': '4.979', 'groupId': 'OG000'}]}]}, {'title': 'Week 24; n=247', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.26', 'spread': '4.828', 'groupId': 'OG000'}]}]}, {'title': 'Week 36; n=234', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.06', 'spread': '5.256', 'groupId': 'OG000'}]}]}, {'title': 'Week 48; n=228', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.51', 'spread': '5.531', 'groupId': 'OG000'}]}]}, {'title': 'Week 60; n=215', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.00', 'spread': '5.940', 'groupId': 'OG000'}]}]}, {'title': 'Week 72; n=217', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.02', 'spread': '5.726', 'groupId': 'OG000'}]}]}, {'title': 'Week 84; n=203', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.68', 'spread': '5.798', 'groupId': 'OG000'}]}]}, {'title': 'Week 96; n=213', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.44', 'spread': '6.409', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at Day 8, Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84 and 96', 'description': 'Percentage CD4+ T- cell counts were assessed by flow cytometry. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as the value at post-dose visit minus the value at Baseline.', 'unitOfMeasure': 'Percentage of CD4+ T- cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Viral Genotypic Substitution of Interest in the GP160 Domain as a Measure of Genotypic Resistance-Randomized Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants were randomized to receive fostemsavir 600 mg BID or placebo along with their current failing antiretroviral regimen during the double-blind period for 8 days. During the open-label period, all participants received open-label fostemsavir 600 mg BID in combination with OBT for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 96', 'description': 'Plasma samples were collected for emergent drug resistance testing. The number of participants with emergent viral genotypic substitutions of interest in the GP160 domain was identified by the next-generation sequencing (NGS) assay. Protocol defined virologic failure (PDVF) through Week 96 Population comprised of all participants with available phenotypic and genotypic resistance data meeting at the time protocol defined virologic failure (PDVF) was met. The criteria for PDVF was a) Confirmed, or last available prior to discontinuation, HIV-1 RNA \\>=400 c/mL at any time after prior confirmed suppression to \\<400 c/mL prior to Week 24 or Confirmed, or last available prior to discontinuation, \\> 1 log10 c/mL increase in HIV-1 RNA at any time above nadir level where nadir is \\>=40 c/mL prior to Week 24. b) Confirmed, or last available prior to discontinuation, HIV-1 RNA \\>=400 c/mL at or after Week 24.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PDVF through Week 96 Population. Only participants available at the specified time point were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Indicated Fold Change Ratio (FCR) Using the Monogram PhenoSense Entry Assay-Randomized Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants were randomized to receive fostemsavir 600 mg BID or placebo along with their current failing antiretroviral regimen during the double-blind period for 8 days. During the open-label period, all participants received open-label fostemsavir 600 mg BID in combination with OBT for at least 96 weeks.'}], 'classes': [{'title': '<=1', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': '>1 to 3', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': '>3 to 10', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '>10 to 100', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '>100 to 3000', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': '>3000', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 96', 'description': 'The phenotypic resistance to a drug is defined in terms of a fold change (FC) in IC50s, i.e., the ratio of the 50% inhibitory concentration (IC50) of the clinical isolate to the IC50 of a reference strain (wild type control). FCR was calculated as FC at PDVF divided by Baseline FC. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. FCR\\<1 indicates that FC is smaller on-treatment than at Baseline. FCR \\>3 indicates that on-treatment FC is 3 times greater than it was at Baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PDVF through Week 96 Population. Only participants available at the specified time point were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Randomized Cohort-Placebo', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).'}, {'id': 'FG001', 'title': 'Randomized Cohort-fostemsavir 600 mg BID', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.'}, {'id': 'FG002', 'title': 'Non-randomized Cohort-fostemsavir 600 mg BID-Open Label Period', 'description': 'Eligible participants in the Non-randomized Cohort had zero remaining fully active and approved antiretroviral regimens at Baseline. Participants received fostemsavir 600 mg BID in combination with OBT.'}], 'periods': [{'title': 'Double-blind Period-Up to 8 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '203'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '199'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'No longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Open Label Period-Up to 96 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '199'}, {'groupId': 'FG002', 'numSubjects': '99'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '199'}, {'groupId': 'FG002', 'numSubjects': '99'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'No longer meets criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Ongoing at the time of analysis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '159'}, {'groupId': 'FG002', 'numSubjects': '61'}]}]}], 'recruitmentDetails': 'This was a 2 cohort Phase 3 study conducted in heavily treatment experienced (HTE) participants infected with multi-drug resistant human immunodeficiency virus (HIV)-1. Participants were assigned to either the Randomized Cohort (participants received either fostemsavir or placebo) or Non-randomized Cohort (all participants received fostemsavir).', 'preAssignmentDetails': 'A total of 731 participants were screened, of which 371 were included in either Randomized Cohort or Non-randomized Cohort and received at least one dose of study treatment. The results presented are based on Week 96 interim analysis. Data collection is still on-going and additional results will be provided after study completion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '371', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Randomized Cohort-Placebo', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).'}, {'id': 'BG001', 'title': 'Randomized Cohort-fostemsavir 600 mg BID', 'description': 'Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.'}, {'id': 'BG002', 'title': 'Non-randomized Cohort-fostemsavir 600 mg BID-Open Label Period', 'description': 'Eligible participants in the Non-randomized Cohort had zero remaining fully active and approved antiretroviral regimens at Baseline. Participants received fostemsavir 600 mg BID in combination with OBT.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.0', 'spread': '11.02', 'groupId': 'BG000'}, {'value': '45.2', 'spread': '12.72', 'groupId': 'BG001'}, {'value': '48.1', 'spread': '11.53', 'groupId': 'BG002'}, {'value': '45.6', 'spread': '12.20', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '289', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race customized', 'categories': [{'title': 'Black or African American', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or other Pacific islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '259', 'groupId': 'BG003'}]}, {'title': 'Mixed', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Hispanic', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Mestizo', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'North African', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Mulatto', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Brown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'White and African descent', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 371}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2015-02-09', 'resultsFirstSubmitDate': '2018-08-02', 'studyFirstSubmitQcDate': '2015-02-12', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-20', 'studyFirstPostDateStruct': {'date': '2015-02-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Logarithm to the Base 10 (log10) HIV-1 Ribonucleic Acid (RNA) From Day 1 at Day 8-Randomized Cohort', 'timeFrame': 'Day 1 and Day 8', 'description': 'Plasma samples were collected for analysis of HIV-1 RNA. Mean change in log10 HIV-1 RNA from Day 1 was estimated using analysis of covariance (ANCOVA) with log10 HIV-1 RNA change from Day 1 at Day 8 as dependent variable, treatment (fostemsavir or placebo) as an independent variable, and Day 1 log10 HIV-1 RNA as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. The analysis was performed on Intent-to-Treat Exposed (ITT-E) Population which comprised of all randomized participants who received at least one dose of study treatment. Missing HIV-1 RNA values at Day 8 were imputed using (a) Day 1 Observation Carried Forward (D1OCF) for participants without a value during blinded treatment (i.e, imputing a zero change from Day 1) or (b) Last Observation Carried Forward (LOCF) for participants with an early value during blinded treatment before the Day 8 analysis visit window.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With HIV-1 RNA Decreases From Day 1 That Exceed 0.5 log10 c/mL and 1.0 log10 c/mL at Day 8-Randomized Cohort', 'timeFrame': 'Day 1 and Day 8', 'description': 'The percentage of participants in the Randomized Cohort with HIV-1 RNA decreases from Day 1 that exceed 0.5 log10 c/mL and 1.0 log10 c/mL at Day 8 was determined by comparing HIV-1 RNA Day 1 measurement of each participant to their Day 8 measurement. This was an ITT analysis that classified participants without HIV-1 RNA at Day 1 or Day 8 as failures. The percentage of responders along with 95% confidence interval based on Wilson score is presented.'}, {'measure': 'Percentage of Participants With HIV-1 RNA <40 c/mL at Weeks 24, 48 and 96-Randomized Cohort', 'timeFrame': 'At Weeks 24, 48 and 96', 'description': 'The durability of response (that is, the number of participants achieving HIV-1 RNA \\<40 c/mL) at Weeks 24, 48 and 96 of open-label fostemsavir plus OBT in the Randomized Cohort was assessed using the Food and Drug Administration (FDA) snapshot algorithm in which participants without HIV-1 RNA at Weeks 24, 48 and 96 or those who changed OBT due to lack of efficacy through Weeks 24, 48 and 96 were counted as failures. The percentage of participants in the Randomized Cohort who achieved virologic success (HIV-1 RNA \\<40 c/mL) at Weeks 24, 48 and 96 is presented along with 95% Wilson confidence interval. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.'}, {'measure': 'Number of Participants With On-treatment Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Randomized Cohort', 'timeFrame': 'Up to Week 96 analysis cut-off date', 'description': 'An SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or causes prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; an important medical event that may jeopardize the participant or require intervention. Number of participants with on-treatment SAEs and AEs leading to withdrawal of study treatment is presented. SAEs and AELDs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.'}, {'measure': 'Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort', 'timeFrame': 'Baseline and up to Week 96 analysis cut-off date', 'description': 'Laboratory toxicities were graded for severity according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading system: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (potentially life-threatening). Baseline is defined as the latest pre-dose assessment. The number of participants with clinical chemistry toxicity grade increase to Grade 3-4 at anytime post-Baseline relative to Baseline is presented. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.'}, {'measure': 'Number of Participants With Toxicity Grade Increase in Hematology Results to Grade 3-4 Relative to Baseline-Randomized Cohort', 'timeFrame': 'Baseline and up to Week 96 analysis cut-off date', 'description': 'Laboratory toxicities were graded for severity according to the DAIDS grading system: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (potentially life-threatening). Baseline is defined as the latest pre-dose assessment. The number of participants with hematology toxicity grade increase to Grade 3-4 at anytime post-Baseline relative to Baseline is presented. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.'}, {'measure': 'Number of Participants With Centers for Disease Control (CDC) Class C Events-Randomized Cohort', 'timeFrame': 'Up to Week 96 analysis cut-off date', 'description': 'Disease progression during open label fostemsavir plus OBT was assessed based on the occurrence of new AIDS defining events (CDC Class C events) or death. The number of participants with on-treatment CDC Class C AIDS events is presented. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.'}, {'measure': 'Change From Day 1 in Cluster of Differentiation (CD) 4+ T-cell Count at Day 8-Randomized Cohort', 'timeFrame': 'Day 1 and Day 8', 'description': 'CD4+ T- cell counts were assessed by flow cytometry. Mean change in CD4+ T- cell count from Day 1 at Day 8 was analyzed using one-way ANCOVA with change of CD4+ cell counts from Day 1 at Day 8 as the dependent variable, treatment (fostemsavir or placebo) as an in-dependent variable, and Day 1 CD4+ cell count as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. Missing CD4+ cell count values at Day 8 were imputed using (a) D1OCF for participants without a value during blinded treatment (i.e., imputing a zero change from Day 1), or (b) LOCF for participants with an early value during blinded treatment before the Day 8 analysis visit window.'}, {'measure': 'Change in CD4+ T- Cell Count Percentage From Day 1 at Day 8-Randomized Cohort', 'timeFrame': 'Day 1 and Day 8', 'description': 'CD4+ T- cell counts were assessed by flow cytometry. Mean change in CD4+ T- cell count percentage from Day 1 at Day 8 was analyzed using one-way ANCOVA with change of CD4+ cell count percentage from Day 1 at Day 8 as the dependent variable, treatment (fostemsavir or placebo) as an independent variable, and Day 1 CD4+ cell count percentage as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. Missing CD4+ cell count values at Day 8 were imputed using (a) D1OCF for participants without a value during blinded treatment (ie, imputing a zero change from Day 1), or (b) LOCF for participants with an early value during blinded treatment before the Day 8 analysis visit window.'}, {'measure': 'Change From Baseline in log10 HIV-1 RNA for Fostemsavir When Given With OBT Through Week 96-Randomized Cohort', 'timeFrame': 'Baseline and at Day 8, Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84 and 96', 'description': 'Blood samples were collected for the analysis of HIV-1 RNA. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as the value at post-dose visit minus the value at Baseline. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.'}, {'measure': 'Change From Baseline in CD4+ T- Cell Count Through Week 96-Randomized Cohort', 'timeFrame': 'Baseline and at Day 8, Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84 and 96', 'description': 'CD4+ T- cell counts were assessed by flow cytometry. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as the value at post-dose visit minus the value at Baseline.'}, {'measure': 'Change From Baseline in CD4+ T- Cell Count Percentage Through Week 96', 'timeFrame': 'Baseline and at Day 8, Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84 and 96', 'description': 'Percentage CD4+ T- cell counts were assessed by flow cytometry. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as the value at post-dose visit minus the value at Baseline.'}, {'measure': 'Number of Participants With Treatment-emergent Viral Genotypic Substitution of Interest in the GP160 Domain as a Measure of Genotypic Resistance-Randomized Cohort', 'timeFrame': 'Week 96', 'description': 'Plasma samples were collected for emergent drug resistance testing. The number of participants with emergent viral genotypic substitutions of interest in the GP160 domain was identified by the next-generation sequencing (NGS) assay. Protocol defined virologic failure (PDVF) through Week 96 Population comprised of all participants with available phenotypic and genotypic resistance data meeting at the time protocol defined virologic failure (PDVF) was met. The criteria for PDVF was a) Confirmed, or last available prior to discontinuation, HIV-1 RNA \\>=400 c/mL at any time after prior confirmed suppression to \\<400 c/mL prior to Week 24 or Confirmed, or last available prior to discontinuation, \\> 1 log10 c/mL increase in HIV-1 RNA at any time above nadir level where nadir is \\>=40 c/mL prior to Week 24. b) Confirmed, or last available prior to discontinuation, HIV-1 RNA \\>=400 c/mL at or after Week 24.'}, {'measure': 'Number of Participants With Indicated Fold Change Ratio (FCR) Using the Monogram PhenoSense Entry Assay-Randomized Cohort', 'timeFrame': 'Week 96', 'description': 'The phenotypic resistance to a drug is defined in terms of a fold change (FC) in IC50s, i.e., the ratio of the 50% inhibitory concentration (IC50) of the clinical isolate to the IC50 of a reference strain (wild type control). FCR was calculated as FC at PDVF divided by Baseline FC. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. FCR\\<1 indicates that FC is smaller on-treatment than at Baseline. FCR \\>3 indicates that on-treatment FC is 3 times greater than it was at Baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '32212519', 'type': 'BACKGROUND', 'citation': 'Kozal M, Aberg J, Pialoux G, Cahn P, Thompson M, Molina JM, Grinsztejn B, Diaz R, Castagna A, Kumar P, Latiff G, DeJesus E, Gummel M, Gartland M, Pierce A, Ackerman P, Llamoso C, Lataillade M; BRIGHTE Trial Team. Fostemsavir in Adults with Multidrug-Resistant HIV-1 Infection. N Engl J Med. 2020 Mar 26;382(13):1232-1243. doi: 10.1056/NEJMoa1902493.'}, {'pmid': '40990223', 'type': 'DERIVED', 'citation': 'Benlarbi M, Richard J, Clemente T, Bourassa C, Tolbert WD, Prakash M, Chandravanshi M, Clark A, Pazgier M, Durand M, Castagna A, Finzi A. Fostemsavir Decreases the Levels of Anti-gp120 CD4-Induced Antibodies in Heavily Treatment-Experienced People With HIV. J Infect Dis. 2025 Sep 24:jiaf461. doi: 10.1093/infdis/jiaf461. Online ahead of print.'}, {'pmid': '39233711', 'type': 'DERIVED', 'citation': 'Clark A, Prakash M, Chabria S, Pierce A, Castillo-Mancilla JR, Wang M, Du F, Tenorio AR. Inflammatory Biomarker Reduction With Fostemsavir Over 96 Weeks in Heavily Treatment-Experienced Adults With Multidrug-Resistant HIV-1 in the BRIGHTE Study. 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Infect Dis Ther. 2023 Sep;12(9):2321-2335. doi: 10.1007/s40121-023-00870-6. Epub 2023 Sep 26.'}, {'pmid': '35502922', 'type': 'DERIVED', 'citation': 'Gartland M, Cahn P, DeJesus E, Diaz RS, Grossberg R, Kozal M, Kumar P, Molina JM, Mendo Urbina F, Wang M, Du F, Chabria S, Clark A, Garside L, Krystal M, Mannino F, Pierce A, Ackerman P, Lataillade M. Week 96 Genotypic and Phenotypic Results of the Fostemsavir Phase 3 BRIGHTE Study in Heavily Treatment-Experienced Adults Living with Multidrug-Resistant HIV-1. Antimicrob Agents Chemother. 2022 Jun 21;66(6):e0175121. doi: 10.1128/aac.01751-21. Epub 2022 May 3.'}, {'pmid': '34180035', 'type': 'DERIVED', 'citation': 'Anderson SJ, Murray M, Cella D, Grossberg R, Hagins D, Towner W, Wang M, Clark A, Pierce A, Llamoso C, Ackerman P, Lataillade M. Patient-Reported Outcomes in the Phase III BRIGHTE Trial of the HIV-1 Attachment Inhibitor Prodrug Fostemsavir in Heavily Treatment-Experienced Individuals. Patient. 2022 Jan;15(1):131-143. doi: 10.1007/s40271-021-00534-y. Epub 2021 Jun 28.'}, {'pmid': '33128903', 'type': 'DERIVED', 'citation': 'Lataillade M, Lalezari JP, Kozal M, Aberg JA, Pialoux G, Cahn P, Thompson M, Molina JM, Moreno S, Grinsztejn B, Diaz RS, Castagna A, Kumar PN, Latiff GH, De Jesus E, Wang M, Chabria S, Gartland M, Pierce A, Ackerman P, Llamoso C. Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced individuals: week 96 results of the phase 3 BRIGHTE study. Lancet HIV. 2020 Nov;7(11):e740-e751. doi: 10.1016/S2352-3018(20)30240-X.'}, {'pmid': '32027457', 'type': 'DERIVED', 'citation': 'Lagishetty C, Moore K, Ackerman P, Llamoso C, Magee M. Effects of Temsavir, Active Moiety of Antiretroviral Agent Fostemsavir, on QT Interval: Results From a Phase I Study and an Exposure-Response Analysis. Clin Transl Sci. 2020 Jul;13(4):769-776. doi: 10.1111/cts.12763. Epub 2020 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and non-pregnant women with chronic HIV-1 infection\n* Antiretroviral-experienced with documented historical or baseline resistance, intolerability, and/or contraindications to antiretrovirals in at least three classes\n* Failing current antiretroviral regimen with a confirmed plasma HIV-1 RNA ≥ 400 c/mL (first value from Investigator, second from Screening labs)\n* Must have ≤ 2 classes with at least 1 but no more than 2 fully-active antiretrovirals remaining which can be effectively combined to form a viable new regimen, based on current and/or documented historical resistance testing and tolerability and safety\n* Able to receive ≥ 1 fully active approved antiretroviral as part of the OBT from Day 9 onwards in the Randomized Cohort\n* Subjects without any remaining fully active approved antiretroviral may be enrolled in the Non-Randomized Cohort\n\nExclusion Criteria:\n\n* Chronic untreated Hepatitis B virus (HBV) (however, patients with chronic treated HBV are eligible)\n* HIV-2 infection\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 7 x ULN\n* Alkaline Phosphatase \\> 5 x ULN\n* Bilirubin ≥ 1.5 x Upper limit of normal (ULN) (unless subject is currently on atazanavir and has predominantly unconjugated hyperbilirubinemia)'}, 'identificationModule': {'nctId': 'NCT02362503', 'briefTitle': 'Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'A Multi-arm, Phase 3, Randomized, Placebo Controlled, Double Blind Clinical Trial to Investigate the Efficacy and Safety of Fostemsavir (BMS-663068/GSK3684934) in Heavily Treatment Experienced Subjects Infected With Multi-drug Resistant HIV-1 (BRIGHTE Study)', 'orgStudyIdInfo': {'id': '205888'}, 'secondaryIdInfos': [{'id': 'AI438-047', 'type': 'OTHER', 'domain': 'Bristol-Myers Squibb'}, {'id': '2014-002111-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A1: BMS-663068', 'description': 'Phase 1: BMS-663068 600 mg tablets orally twice daily for 8 days. 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Phase 2: BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.', 'interventionNames': ['Drug: BMS-663068', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-663068', 'description': 'BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.', 'interventionNames': ['Drug: BMS-663068']}], 'interventions': [{'name': 'BMS-663068', 'type': 'DRUG', 'description': 'BMS-663068', 'armGroupLabels': ['A1: BMS-663068', 'B1: Placebo + BMS-663068', 'BMS-663068']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['B1: Placebo + BMS-663068']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90008', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90069', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '34982', 'city': 'Ft. 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