Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-27 @ 10:52 PM
Study NCT ID:
NCT01933594
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2013-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating the Safety and Efficacy of Romidepsin in Combination With Antiretroviral Therapy in HIV-Infected Adults With Suppressed Viral Load
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': 'C087123', 'term': 'romidepsin'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ACTGCT.Gov@s-3.com', 'phone': '(301) 628-3313', 'title': 'ACTG Clinicaltrials.gov Coordinator', 'organization': 'ACTG Network Coordinating Center, Social and Scientific Systems, Inc.'}, 'certainAgreement': {'otherDetails': 'In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from study entry until the end of study (28 days for Cohorts 1-3 and up to 48 weeks for Cohort 4).', 'description': 'The protocol required reporting of all diagnoses, all signs/symptoms/laboratory values Grade ≥ 2, and all signs/symptoms/laboratory values that led to treatment change and/or Grade ≥ 3 and/or met EAE or ICH reporting requirements. For grading, sites referred to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), http://rsc.tech-res.com/clinical-research-sites/safety-reporting.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1-Arm 1A (Romidepsin)', 'description': 'Participants in Cohort 1, Arm 1A received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 8, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 2-Arm 2A (Romidepsin)', 'description': 'Participants in Cohort 2, Arm 2A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 3-Arm 3A (Romidepsin)', 'description': 'Participants in Cohort 3, Arm 3A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohorts 1-3 (Placebo for Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 3, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 9, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abscess bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bacterial vaginosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Viral tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Creatinine renal clearance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Electrocardiogram PR prolongation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Electrocardiogram QT interval normal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haemoglobin abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abnormal loss of weight', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Joint noise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Mobility decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chromaturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper-airway cough syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nail discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominoplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Abdominal wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants With Grade 3 or Higher Adverse Events (AEs) in Cohorts 1-3 Romidepsin Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohorts 1-3 (Romidepsin)', 'description': 'Participants in Cohorts 1-3 received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.097'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from the time of Romidepsin administration (at entry) until 28 days after the administration', 'description': 'Proportion of participants with Grade 3 or higher adverse events (AEs) in Cohorts 1-3 Romidepsin Arms, including signs/symptoms, lab toxicities, and /or clinical events probably, possibly, or definitely related to study treatment (as judged by the core team, blinded to treatment arm). The DAIDS AE Grading Table (Version 1.0) was used.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Cohorts 1-3 who received Romidepsin'}, {'type': 'PRIMARY', 'title': 'Proportion of Participants With Grade 3 or Higher Adverse Events (AEs) in Cohort 4 Romidepsin Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4 received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.077', 'groupId': 'OG000', 'lowerLimit': '0.002', 'upperLimit': '0.36'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from the time of the first Romidepsin administration through 28 days after the last administration (at day 42)', 'description': 'Proportion of participants with Grade 3 or Higher Adverse Events (AEs) in Cohort 4 Romidepsin Arm, including signs/symptoms, lab toxicities, and /or clinical events probably, possibly, or definitely related to study treatment (as judged by the core team, blinded to treatment arm). The DAIDS AE Grading Table (Version 1.0) was used.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Cohort 4 who received Romidepsin'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Plasma HIV-1 RNA Levels as Detected by Single Copy Assay in Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohorts 1-3 (Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG001', 'title': 'Cohorts 1-3 (Placebo for Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000', 'lowerLimit': '-0.18', 'upperLimit': '0.42'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '-0.24', 'upperLimit': '0.67'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-entry, entry, 24 and 48 hours after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the average of the pre-entry and entry values. Hour 24/48 is defined as the average of values at 24 and 48 hours after the single administration of Romidepsin or placebo (at study entry).\n\nChange was calculated as the value at hour 24/48 minus the value at baseline.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohorts 1-3 participants'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Plasma HIV-1 RNA Levels as Detected by Single Copy Assay in Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}, {'id': 'OG001', 'title': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}], 'classes': [{'title': 'Change from baseline to 24 hours post infusion 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-0.32', 'upperLimit': '0.23'}, {'value': '-0.11', 'groupId': 'OG001', 'lowerLimit': '-0.45', 'upperLimit': '0.55'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '-0.03', 'upperLimit': '0.53'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '-0.23', 'upperLimit': '1.24'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.45'}, {'value': '0.47', 'groupId': 'OG001', 'lowerLimit': '0.33', 'upperLimit': '0.63'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-0.17', 'upperLimit': '0.23'}, {'value': '0.33', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '0.33'}]}]}], 'analyses': [{'pValue': '0.94', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.74', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 2', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 3', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-entry, entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)', 'description': 'Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) minus the value at baseline.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 4 participants'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Cell-associated HIV-1 RNA Levels in Resting CD4 T-cells in Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohorts 1-3 (Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG001', 'title': 'Cohorts 1-3 (Placebo for Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.009', 'groupId': 'OG000', 'lowerLimit': '-0.38', 'upperLimit': '0.26'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-0.22', 'upperLimit': '0.36'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-entry and 24 hours after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the pre-entry value. Change was calculated as the value at 24 hours after administration of Romidepsin or placebo (at entry) minus the value at baseline.', 'unitOfMeasure': 'log10 (copies/10^6 resting CD4 cells)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohorts 1-3 participants'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Cell-associated HIV-1 RNA Levels in PBMCs in Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}, {'id': 'OG001', 'title': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}], 'classes': [{'title': 'Change from baseline to 24 hours post infusion 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'groupId': 'OG000', 'lowerLimit': '-0.14', 'upperLimit': '0.07'}, {'value': '-0.16', 'groupId': 'OG001', 'lowerLimit': '-0.36', 'upperLimit': '0.43'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'groupId': 'OG000', 'lowerLimit': '-0.38', 'upperLimit': '0.31'}, {'value': '-0.52', 'groupId': 'OG001', 'lowerLimit': '-0.91', 'upperLimit': '-0.15'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.44', 'groupId': 'OG000', 'lowerLimit': '-0.69', 'upperLimit': '-0.15'}, {'value': '-0.02', 'groupId': 'OG001', 'lowerLimit': '-1.25', 'upperLimit': '0.04'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.01'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-0.76', 'upperLimit': '0.15'}]}]}], 'analyses': [{'pValue': '0.9', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 2', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.88', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 3', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.92', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-entry, entry and 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)', 'description': 'Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) minus the value at baseline.', 'unitOfMeasure': 'log10 (copies/10^6 PBMCs)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 4 participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Plasma HIV-1 RNA Levels as Detected by Single Copy Assay in Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohorts 1-3 (Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG001', 'title': 'Cohorts 1-3 (Placebo for Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}], 'classes': [{'title': 'Change from baseline to 6 hours post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000', 'lowerLimit': '-0.38', 'upperLimit': '0.22'}, {'value': '0.14', 'groupId': 'OG001', 'lowerLimit': '-0.37', 'upperLimit': '0.48'}]}]}, {'title': 'Change from baseline to 12 hours post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-0.49', 'upperLimit': '0.2'}, {'value': '0.27', 'groupId': 'OG001', 'lowerLimit': '0.14', 'upperLimit': '0.57'}]}]}, {'title': 'Change from baseline to 7 days post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-0.25', 'upperLimit': '0.39'}, {'value': '0.27', 'groupId': 'OG001', 'lowerLimit': '-0.16', 'upperLimit': '0.63'}]}]}, {'title': 'Change from baseline to 14 days post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.15'}, {'value': '-0.13', 'groupId': 'OG001', 'lowerLimit': '-0.39', 'upperLimit': '0.27'}]}]}, {'title': 'Change from baseline to 28 days post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.3'}, {'value': '-0.08', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '0.09'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 6 hours post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 12 hours post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.37', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 7 days post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.79', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 14 days post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.34', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 28 days post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-entry, entry, 6 hours, 12 hours, 7 days, 14 days and 28 days after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 6 hours, 12 hours, 7 days, 14 days and 28 days after administration of Romidepsin or placebo (at entry) minus the value at baseline.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohorts 1-3 participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Plasma HIV-1 RNA Levels as Detected by Single Copy Assay in Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}, {'id': 'OG001', 'title': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-0.54', 'upperLimit': '0.1'}, {'value': '0.82', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '0.86'}]}]}], 'analyses': [{'pValue': '0.029', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-entry, entry and 72 hours after the second administration of Romidepsin or placebo (at day 14)', 'description': 'Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 72 hours after the second administration of Romidepsin or placebo (at day 14) minus the value at baseline.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 4 participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cell-associated HIV-1 RNA Levels in Resting CD4 T Cells in Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohorts 1-3 (Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG001', 'title': 'Cohorts 1-3 (Placebo for Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '-0.42', 'upperLimit': '0.31'}, {'value': '-0.05', 'groupId': 'OG001', 'lowerLimit': '-0.38', 'upperLimit': '0.46'}]}]}], 'analyses': [{'pValue': '0.96', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-entry and 14 days after the administration of RMD or placebo (at entry)', 'description': 'Baseline is defined as the pre-entry value. Change was calculated as the value at 14 days after administration of Romidepsin or placebo (at entry) minus the value at baseline.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohorts 1-3 participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cell-associated HIV-1 RNA Levels in PBMCs in Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}, {'id': 'OG001', 'title': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.26', 'groupId': 'OG000', 'lowerLimit': '-0.48', 'upperLimit': '0.17'}, {'value': '-0.16', 'groupId': 'OG001', 'lowerLimit': '-0.25', 'upperLimit': '0.14'}]}]}], 'analyses': [{'pValue': '0.54', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-entry and 72 hours after the second administration of Romidepsin or placebo (at day 14)', 'description': 'Baseline is defined as the pre-entry value. Change was calculated as the value at 72 hours after the second administration of Romidepsin or placebo (at day 14) minus the value at baseline.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 4 participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Histone Acetylation (Median FITC Ac-Histone) in CD3+ Cells in Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohorts 1-3 (Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG001', 'title': 'Cohorts 1-3 (Placebo for Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7', 'groupId': 'OG000', 'lowerLimit': '-969', 'upperLimit': '1606'}, {'value': '-194', 'groupId': 'OG001', 'lowerLimit': '-1529', 'upperLimit': '1343'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Hour 0 and 24 hours after the single administration of RMD or placebo (at entry)', 'description': 'Baseline is defined as the value at Hour 0, right before the single administration of Romidepsin or placebo.\n\nChange was calculated as the value at 24 hours after administration of Romidepsin or placebo (at entry) minus the value at baseline.\n\nMedian Fluorescent Intensity (MFI) data describes a shift in the expression of a fluorescently labeled marker on a population of cells. The reported MFI is an arbitrary value dependent on the voltage applied to the corresponding flow cytometer detector.', 'unitOfMeasure': 'arbitrary units', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohorts 1-3 participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Histone Acetylation in (Median FITC Ac-histone) in CD3+ Cells in Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}, {'id': 'OG001', 'title': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}], 'classes': [{'title': 'Change from baseline to 24 hours post infusion 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2402', 'groupId': 'OG000', 'lowerLimit': '1257', 'upperLimit': '3821'}, {'value': '749', 'groupId': 'OG001', 'lowerLimit': '-129', 'upperLimit': '1498'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2774', 'groupId': 'OG000', 'lowerLimit': '1467', 'upperLimit': '5086'}, {'value': '8497', 'groupId': 'OG001', 'lowerLimit': '696', 'upperLimit': '8684'}]}]}, {'title': 'Change from baseline to 72 hours post infusion 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4741', 'groupId': 'OG000', 'lowerLimit': '3065', 'upperLimit': '8518'}, {'value': '4741', 'groupId': 'OG001', 'lowerLimit': '2479', 'upperLimit': '13283'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4522', 'groupId': 'OG000', 'lowerLimit': '2388', 'upperLimit': '8763'}, {'value': '5665', 'groupId': 'OG001', 'lowerLimit': '1041', 'upperLimit': '7154'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4342', 'groupId': 'OG000', 'lowerLimit': '3101', 'upperLimit': '26464'}, {'value': '2697', 'groupId': 'OG001', 'lowerLimit': '937', 'upperLimit': '4022'}]}]}], 'analyses': [{'pValue': '0.19', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.63', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 2', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.94', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 72 hours post infusion 2', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.66', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 3', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42), and 72 hours after the second administration (at day 14)', 'description': 'Baseline is defined as the value right before the first administration of Romidepsin or placebo (at entry).\n\nChange was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration minus the value at baseline.\n\nMedian Fluorescent Intensity (MFI) data describes a shift in the expression of a fluorescently labeled marker on a population of cells. The reported MFI is an arbitrary value dependent on the voltage applied to the corresponding flow cytometer detector.', 'unitOfMeasure': 'arbitrary units', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 4 participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total HIV-1 DNA in Resting or Total CD4 T Cells in Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohorts 1-3 (Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG001', 'title': 'Cohorts 1-3 (Placebo for Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}], 'classes': [{'title': 'Change from baseline to 24 hours post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'groupId': 'OG000', 'lowerLimit': '-0.18', 'upperLimit': '0.06'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '-0.41', 'upperLimit': '0.19'}]}]}, {'title': 'Change from baseline to 14 days post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000', 'lowerLimit': '-0.21', 'upperLimit': '0.06'}, {'value': '-0.05', 'groupId': 'OG001', 'lowerLimit': '-0.24', 'upperLimit': '0.08'}]}]}], 'analyses': [{'pValue': '0.73', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 14 days post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-entry, 24 hours and 14 days after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the pre-entry value. Change was calculated as the value at 24 hours and 14 days after administration of Romidepsin or placebo (at entry) minus the value at baseline.', 'unitOfMeasure': 'log10 (copies/10^6 resting CD4 cells)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohorts 1-3 participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total HIV-1 DNA in PBMCs in Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}, {'id': 'OG001', 'title': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}], 'classes': [{'title': 'Change from baseline to 24 hours post infusion 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '-0.03'}, {'value': '-0.04', 'groupId': 'OG001', 'lowerLimit': '-0.26', 'upperLimit': '0.03'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'groupId': 'OG000', 'lowerLimit': '-0.22', 'upperLimit': '-0.04'}, {'value': '-0.11', 'groupId': 'OG001', 'lowerLimit': '-0.12', 'upperLimit': '-0.06'}]}]}, {'title': 'Change from baseline to 72 hours post infusion 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'groupId': 'OG000', 'lowerLimit': '-0.25', 'upperLimit': '-0.05'}, {'value': '-0.07', 'groupId': 'OG001', 'lowerLimit': '-0.25', 'upperLimit': '-0.04'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'groupId': 'OG000', 'lowerLimit': '-0.46', 'upperLimit': '-0.03'}, {'value': '-0.13', 'groupId': 'OG001', 'lowerLimit': '-0.14', 'upperLimit': '-0.07'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'groupId': 'OG000', 'lowerLimit': '-0.28', 'upperLimit': '-0.02'}, {'value': '-0.07', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '-0.04'}]}]}], 'analyses': [{'pValue': '0.8', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.73', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 2', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.84', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 72 hours post infusion 2', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.88', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 3', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.64', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14)', 'description': 'Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration minus the value at baseline.', 'unitOfMeasure': 'log10 (copies/10^6 PBMCs)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 4 participants with available data'}, {'type': 'SECONDARY', 'title': 'PK Parameters for Romidepsin and Co-administered Antiretroviral Drugs (Efavirenz, Dolutegravir, or Raltegravir) in Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1-Arm 1A (Romidepsin)', 'description': 'Participants in Cohort 1, Arm 1A received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG001', 'title': 'Cohort 2-Arm 2A (Romidepsin)', 'description': 'Participants in Cohort 2, Arm 2A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG002', 'title': 'Cohort 3-Arm 3A (Romidepsin)', 'description': 'Participants in Cohort 3, Arm 3A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG003', 'title': 'Cohorts 1-3 (Placebo for Romidepsin)', 'description': 'Participants in Cohorts 1-3, received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}], 'classes': [{'title': 'RMD PK concentration at Hour 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'All 12 participants had concentration \\<= BQL (below quantifiable limit)', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'All 12 participants had concentration \\<= BQL (below quantifiable limit)', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'All 12 participants had concentration \\<= BQL (below quantifiable limit)', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'RMD PK concentration at Hour 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '16.7'}, {'value': '75.2', 'groupId': 'OG001', 'lowerLimit': '54.1', 'upperLimit': '84'}, {'value': '89', 'groupId': 'OG002', 'lowerLimit': '53.3', 'upperLimit': '127.5'}]}]}, {'title': 'RMD PK concentration at Hour 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '3.2'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '4.2'}, {'value': '2.6', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '5'}]}]}, {'title': 'RMD PK concentration at Hour 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'All 12 participants had concentration \\<= BQL (below quantifiable limit)', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'All 12 participants had concentration \\<= BQL (below quantifiable limit)', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'All 12 participants had concentration \\<= BQL (below quantifiable limit)', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'RMD PK concentration at Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'All 12 participants had concentration \\<= BQL (below quantifiable limit)', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'All 12 participants had concentration \\<= BQL (below quantifiable limit)', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'All 12 participants had concentration \\<= BQL (below quantifiable limit)', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'EFV PK concentration at Hour 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2030', 'groupId': 'OG000', 'lowerLimit': '1570', 'upperLimit': '3750'}, {'value': '2560', 'groupId': 'OG001', 'lowerLimit': '2490', 'upperLimit': '2640'}, {'value': '2612', 'groupId': 'OG002', 'lowerLimit': '1995', 'upperLimit': '3423'}, {'value': '2520', 'groupId': 'OG003', 'lowerLimit': '2000', 'upperLimit': '2758'}]}]}, {'title': 'EFV PK concentration at Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2105', 'groupId': 'OG000', 'lowerLimit': '1665', 'upperLimit': '3405'}, {'value': '1870', 'groupId': 'OG001', 'lowerLimit': '1700', 'upperLimit': '2390'}, {'value': '2886', 'groupId': 'OG002', 'lowerLimit': '2262', 'upperLimit': '4016'}, {'value': '1600', 'groupId': 'OG003', 'lowerLimit': '1530', 'upperLimit': '1849'}]}]}, {'title': 'RAL PK concentration at Hour 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '777', 'groupId': 'OG000', 'lowerLimit': '294', 'upperLimit': '1990'}, {'value': '910', 'groupId': 'OG001', 'lowerLimit': '845', 'upperLimit': '939'}, {'value': '401', 'groupId': 'OG003', 'lowerLimit': '267', 'upperLimit': '726'}]}]}, {'title': 'RAL PK concentration at Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1234', 'groupId': 'OG000', 'lowerLimit': '526', 'upperLimit': '3475'}, {'value': '398', 'groupId': 'OG001', 'lowerLimit': '348', 'upperLimit': '558'}, {'value': '142', 'groupId': 'OG003', 'lowerLimit': '65', 'upperLimit': '390'}]}]}, {'title': 'DTG PK concentration at Hour 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4035', 'groupId': 'OG001', 'lowerLimit': '2740', 'upperLimit': '5330'}, {'value': '2988', 'groupId': 'OG002', 'lowerLimit': '2163', 'upperLimit': '7867'}]}]}, {'title': 'DTG PK concentration at Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2190', 'groupId': 'OG001', 'lowerLimit': '1010', 'upperLimit': '3370'}, {'value': '2399', 'groupId': 'OG002', 'lowerLimit': '1181', 'upperLimit': '3618'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At hours 0, 4, 6, 12 and 24', 'description': 'Hour 0 is right before the single administration of Romidepsin or placebo (at entry).\n\nHour 4 is at the completion of Romidepsin or placebo administration. Hours 6, 12 and 24 are 2, 8 and 20 hours after the completion of Romidepsin or placebo administration.\n\nPK concentration (ng/mL) for Romidepsin at hours 0, 4, 6, 12 and 24. PK concentration (ng/mL) for co-administered antiretroviral drugs (Efavirenz \\[EFV\\], Dolutegravir \\[DTG\\], or Raltegravir \\[RAL\\]) at hours 0 and 24.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'For Romidepsin PK parameters: Cohorts 1-3 participants who received Romidepsin. For co-administered antiretroviral drugs PK parameters: Cohorts 1-3 participants.'}, {'type': 'SECONDARY', 'title': 'PK Parameters for Romidepsin and Co-administered Antiretroviral Drugs (Dolutegravir or Raltegravi) in Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}, {'id': 'OG001', 'title': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}], 'classes': [{'title': 'RMD PK concentration pre infusion 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '207', 'groupId': 'OG000', 'lowerLimit': '207', 'upperLimit': '207'}]}]}, {'title': 'RMD PK concentration post infusion 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '64', 'upperLimit': '164'}]}]}, {'title': 'RMD PK concentration pre infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'All 11 participants had concentration \\<= BQL (below quantifiable limit)', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'RMD PK concentration post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '211'}]}]}, {'title': 'RAL PK concentration 24 hours post infusion 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '906', 'groupId': 'OG000', 'lowerLimit': '119', 'upperLimit': '3420'}]}]}, {'title': 'RAL PK concentration 24 hours post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '567', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '2711'}]}]}, {'title': 'DTG PK concentration 24 hours post infusion 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2124', 'groupId': 'OG000', 'lowerLimit': '1147', 'upperLimit': '3865'}, {'value': '913', 'groupId': 'OG001', 'lowerLimit': '274', 'upperLimit': '1128'}]}]}, {'title': 'DTG PK concentration 24 hours post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1568', 'groupId': 'OG000', 'lowerLimit': '985', 'upperLimit': '2779'}, {'value': '833', 'groupId': 'OG001', 'lowerLimit': '274', 'upperLimit': '1323'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre, post and 24 hours after the third and fourth administrations of Romidepsin or placebo (at days 28 and 42)', 'description': 'PK concentration (ng/mL) for Romidepsin pre and post the third and fourth administrations of Romidepsin or placebo.\n\nPK concentration (ng/mL) for co-administered antiretroviral drugs (Dolutegravir \\[DTG\\], or Raltegravir \\[RAL\\]) 24 hours after the third and fourth administrations of Romidepsin or placebo.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'For Romidepsin PK parameters: Cohort 4 participants who received the third and fourth Romidepsin infusion.\n\nFor co-administered antiretroviral drugs PK parameters: Cohort 4 participants who received the third and fourth Romidepsin or placebo infusion.'}, {'type': 'SECONDARY', 'title': 'HIV-1 RNA Levels in Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1-Arm 1A (Romidepsin)', 'description': 'Participants in Cohort 1, Arm 1A received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG001', 'title': 'Cohort 2-Arm 2A (Romidepsin)', 'description': 'Participants in Cohort 2, Arm 2A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG002', 'title': 'Cohort 3-Arm 3A (Romidepsin)', 'description': 'Participants in Cohort 3, Arm 3A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG003', 'title': 'Cohorts 1-3 (Placebo for Romidepsin)', 'description': 'Participants in Cohorts 1-3, received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}], 'classes': [{'categories': [{'title': '< 40 copies/mL', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}, {'title': '40-199 copies/mL', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days after the administration of Romidepsin or placebo (at entry)', 'description': 'HIV-1 RNA levels at 7 days after the single administration of Romidepsin or placebo (at entry)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohorts 1-3 participants'}, {'type': 'SECONDARY', 'title': 'HIV-1 RNA Levels in Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}, {'id': 'OG001', 'title': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}], 'classes': [{'title': 'HIV-1 RNA level at day 7 post infusion 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'title': '< 40 copies/mL', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': '40 - 199 copies/mL', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HIV-1 RNA level at day 7 post infusion 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'title': '< 40 copies/mL', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': '40 - 199 copies/mL', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HIV-1 RNA level at day 7 post infusion 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'title': '< 40 copies/mL', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': '40 - 199 copies/mL', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HIV-1 RNA level at day 7 post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'title': '< 40 copies/mL', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': '40 - 199 copies/mL', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)', 'description': 'HIV-1 RNA levels at 7 days after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 4 participants with available data'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reported Grade 2-4 AEs in Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1-Arm 1A (Romidepsin)', 'description': 'Participants in Cohort 1, Arm 1A received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG001', 'title': 'Cohort 2-Arm 2A (Romidepsin)', 'description': 'Participants in Cohort 2, Arm 2A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG002', 'title': 'Cohort 3-Arm 3A (Romidepsin)', 'description': 'Participants in Cohort 3, Arm 3A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG003', 'title': 'Cohorts 1-3 (Placebo for Romidepsin)', 'description': 'Participants in Cohorts 1-3, received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured from study entry to off study', 'description': 'Number of participants with reported grade 2-4 adverse events including signs/symptoms, lab toxicities, and clinical events that are at least possibly related to study treatment. The DAIDS AE Grading Table (Version 1.0) was used.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohorts 1-3 participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reported Grade 2-4 AEs in Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}, {'id': 'OG001', 'title': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured from study entry to off study', 'description': 'Number of participants with reported grade 2-4 adverse events including signs/symptoms, lab toxicities, and clinical events that are at least possibly related to study treatment. The DAIDS AE Grading Table (Version 1.0) was used.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 4 participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ and CD8+ T Cell Percent in Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohorts 1-3 (Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG001', 'title': 'Cohorts 1-3 (Placebo for Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}], 'timeFrame': "Measured through participant's last study visit", 'description': 'Change in CD4+ and CD8+T cell percent from baseline to after the single administration of Romidepsin or placebo', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohorts 1-3 participants did not have CD4+ and CD8+ T cell percent collected'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ T Cell Percent in Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}, {'id': 'OG001', 'title': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}], 'classes': [{'title': 'Change from baseline to 24 hours post infusion 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-3.5', 'upperLimit': '-0.5'}, {'value': '-2', 'groupId': 'OG001', 'lowerLimit': '-2', 'upperLimit': '2.5'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.5', 'groupId': 'OG000', 'lowerLimit': '-5.9', 'upperLimit': '-2.4'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '2'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'groupId': 'OG000', 'lowerLimit': '-6.5', 'upperLimit': '-2.5'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '3'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.5', 'groupId': 'OG000', 'lowerLimit': '-7.5', 'upperLimit': '-2.5'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'Change from baseline to 2 weeks post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-4.8', 'upperLimit': '0.5'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '2'}]}]}, {'title': 'Change from baseline to 5 weeks post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '-0.4'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-2.5', 'upperLimit': '0'}]}]}, {'title': 'Change from baseline to 10 weeks post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'groupId': 'OG000', 'lowerLimit': '-3.5', 'upperLimit': '-1.5'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-4', 'upperLimit': '2'}]}]}, {'title': 'Change from baseline to 18 weeks post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-3.2', 'upperLimit': '1.1'}, {'value': '-2.5', 'groupId': 'OG001', 'lowerLimit': '-6', 'upperLimit': '1'}]}]}], 'analyses': [{'pValue': '0.34', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 2', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.022', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 3', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.55', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 2 weeks post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 5 weeks post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.54', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 10 weeks post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.47', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 18 weeks post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-entry, entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42), and 2, 5, 10 and 18 weeks after the fourth administration (at day 42)', 'description': 'Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours post each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 2, 5, 10 and 18 weeks post the fourth administration minus the value at baseline', 'unitOfMeasure': 'percentage of CD4 cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 4 participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD8+ T Cell Percent in Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}, {'id': 'OG001', 'title': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}], 'timeFrame': 'Measured through 28 days after the single administration of RMD or placebo (at entry, and days 14, 28 and 42)', 'description': 'Change in CD8+ T cell percent from baseline to after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 4 participants did not have CD8+ T cell percent collected'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cellular Markers of Immune Activation (CD38/HLA-DR Expression on CD4+ T-cells) in Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohorts 1-3 (Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG001', 'title': 'Cohorts 1-3 (Placebo for Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}], 'classes': [{'title': 'Change from baseline to 48 hours post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '1.8'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '2.8'}]}]}, {'title': 'Change from baseline to 7 days post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '2.7'}, {'value': '-1', 'groupId': 'OG001', 'lowerLimit': '-2', 'upperLimit': '0.8'}]}]}, {'title': 'Change from baseline to 28 days post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '-3.2', 'upperLimit': '2.6'}, {'value': '-1.4', 'groupId': 'OG001', 'lowerLimit': '-2.4', 'upperLimit': '0.2'}]}]}], 'analyses': [{'pValue': '0.95', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 48 hours post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 7 days post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.26', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 28 days post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).\n\nChange was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo minus the value at baseline.', 'unitOfMeasure': 'percentage of CD4 cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohorts 1-3 participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cellular Markers of Immune Activation (CD38/HLA-DR Expression on CD8+ T-cells) in Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohorts 1-3 (Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG001', 'title': 'Cohorts 1-3 (Placebo for Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}], 'classes': [{'title': 'Change from baseline to 48 hours post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '1.8'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '1.3'}]}]}, {'title': 'Change from baseline to 7 days post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '3'}, {'value': '-1.3', 'groupId': 'OG001', 'lowerLimit': '-2', 'upperLimit': '-0.4'}]}]}, {'title': 'Change from baseline to 28 days post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-4.2', 'upperLimit': '3.1'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-2.7', 'upperLimit': '2.4'}]}]}], 'analyses': [{'pValue': '0.89', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 48 hours post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 7 days post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.74', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 28 days post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).\n\nChange was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo minus the value at baseline.', 'unitOfMeasure': 'percentage of CD8 cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohorts 1-3 participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cellular Markers of Immune Activation (CD69/CD25 Expression on CD4+ T-cells) in Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohorts 1-3 (Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG001', 'title': 'Cohorts 1-3 (Placebo for Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}], 'classes': [{'title': 'Change from baseline to 48 hours post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.2'}]}]}, {'title': 'Change from baseline to 7 days post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.4'}]}]}, {'title': 'Change from baseline to 28 days post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.4'}]}]}], 'analyses': [{'pValue': '0.71', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 48 hours post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.79', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 7 days post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.38', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 28 days post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).\n\nChange was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo minus the value at baseline.', 'unitOfMeasure': 'percentage of CD4 cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohorts 1-3 participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cellular Markers of Immune Activation (CD69/CD25 Expression on CD8+ T-cells) in Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohorts 1-3 (Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG001', 'title': 'Cohorts 1-3 (Placebo for Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}], 'classes': [{'title': 'Change from baseline to 48 hours post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}]}]}, {'title': 'Change from baseline to 7 days post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}]}]}, {'title': 'Change from baseline to 28 days post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '1', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 48 hours post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.92', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 7 days post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.66', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 28 days post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).\n\nChange was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo minus the value at baseline.', 'unitOfMeasure': 'percentage of CD8 cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohorts 1-3 participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cellular Markers of Immune Activation (CD38/HLA-DR Expression on CD4+ T-cells) in Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}, {'id': 'OG001', 'title': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}], 'classes': [{'title': 'Change from baseline to 24 hours post infusion 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '1.2'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-1.4', 'upperLimit': '1.1'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '3.5'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '2.3'}]}]}, {'title': 'Change from baseline to 10 weeks post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '1.3'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '2.2'}]}]}], 'analyses': [{'pValue': '1', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.47', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 10 weeks post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at entry and day 42), and 10 weeks after the fourth administration (at day 42)', 'description': 'Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at entry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline.', 'unitOfMeasure': 'percentage of CD4 cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 4 participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cellular Markers of Immune Activation (CD38/HLA-DR Expression on CD8+ T-cells) in Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}, {'id': 'OG001', 'title': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}], 'classes': [{'title': 'Change from baseline to 24 hours post infusion 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '1.8'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.2'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '2.1'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '2.4'}]}]}, {'title': 'Change from baseline to 10 weeks post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-2.8', 'upperLimit': '0.4'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '8.7'}]}]}], 'analyses': [{'pValue': '0.63', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.51', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'hange from baseline to 24 hours post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.028', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 10 weeks post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at entry and day 42), and 10 weeks after the fourth administration (at day 42)', 'description': 'Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at entry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline.', 'unitOfMeasure': 'percentage of CD8 cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 4 participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cellular Markers of Immune Activation (CD69/CD25 Expression on CD4+ T-cells) in Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}, {'id': 'OG001', 'title': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}], 'classes': [{'title': 'Change from baseline to 24 hours post infusion 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.1'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.4'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0'}]}]}, {'title': 'Change from baseline to 10 weeks post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.5'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}]}]}], 'analyses': [{'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.15', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.69', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 10 weeks post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at etnry and day 42), and 10 weeks after the fourth administration (at day 42)', 'description': 'Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at etnry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline.', 'unitOfMeasure': 'percentage of CD4 cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 4 participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cellular Markers of Immune Activation (CD69/CD25 Expression on CD8+ T-cells) in Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}, {'id': 'OG001', 'title': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}], 'classes': [{'title': 'Change from baseline to 24 hours post infusion 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.1'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0'}]}]}, {'title': 'Change from baseline to 10 weeks post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.15', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.81', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 10 weeks post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at etnry and day 42), and 10 weeks after the fourth administration (at day 42', 'description': 'Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at etnry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline.', 'unitOfMeasure': 'percentage of CD8 cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 4 participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage of CD4+ T-cells Expressing Annexin V and/or 7 Amino-actinomycin D (7-AAD) in Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohorts 1-3 (Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG001', 'title': 'Cohorts 1-3 (Placebo for Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}], 'classes': [{'title': 'Change from baseline to 48 hours post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '1'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '7'}]}]}, {'title': 'Change from baseline to 7 days post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-3.7', 'upperLimit': '0.3'}]}]}, {'title': 'Change from baseline to 28 days post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '3.9'}, {'value': '-1.3', 'groupId': 'OG001', 'lowerLimit': '-3.6', 'upperLimit': '0.1'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 48 hours post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 7 days post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.031', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 28 days post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).\n\nChange was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry) minus the value at baseline.', 'unitOfMeasure': 'percentage of CD4 cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohorts 1-3 participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage of CD8+ T-cells Expressing Annexin V and/or 7 Amino-actinomycin D (7-AAD) in Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohorts 1-3 (Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG001', 'title': 'Cohorts 1-3 (Placebo for Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}], 'classes': [{'title': 'Change from baseline to 48 hours post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-2.1', 'upperLimit': '0.6'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '4.3'}]}]}, {'title': 'Change from baseline to 7 days post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '3.1'}, {'value': '-1.1', 'groupId': 'OG001', 'lowerLimit': '-4.6', 'upperLimit': '3.3'}]}]}, {'title': 'Change from baseline to 28 days post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '3'}, {'value': '-1.9', 'groupId': 'OG001', 'lowerLimit': '-4.1', 'upperLimit': '2.5'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 48 hours post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 7 days post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 28 days post infusion', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).\n\nChange was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry) minus the value at baseline.', 'unitOfMeasure': 'percentage of CD8 cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohorts 1-3 participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage of CD4+ T-cells Expressing Annexin V and/or 7 Amino-actinomycin D (7-AAD) in Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}, {'id': 'OG001', 'title': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}], 'classes': [{'title': 'Change from baseline to 24 hours post infusion 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-2.7', 'upperLimit': '1.3'}, {'value': '-1.4', 'groupId': 'OG001', 'lowerLimit': '-2.2', 'upperLimit': '7'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-4.5', 'upperLimit': '3.1'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '2.4'}]}]}, {'title': 'Change from baseline to 10 weeks post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-2.9', 'upperLimit': '1.5'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-3.7', 'upperLimit': '5.8'}]}]}], 'analyses': [{'pValue': '0.7', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.51', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.94', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 10 weeks post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at entry and day 42), and 10 weeks after the fourth administration (at day 42)', 'description': 'Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at entry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline.', 'unitOfMeasure': 'percentage of CD4 cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 4 participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage of CD8+ T-cells Expressing Annexin V and/or 7 Amino-actinomycin D (7-AAD) in Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}, {'id': 'OG001', 'title': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}], 'classes': [{'title': 'Change from baseline to 24 hours post infusion 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-3.7', 'upperLimit': '1.3'}, {'value': '-4.1', 'groupId': 'OG001', 'lowerLimit': '-5.1', 'upperLimit': '8'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-3.3', 'upperLimit': '15.4'}, {'value': '-.6', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '0.3'}]}]}, {'title': 'Change from baseline to 10 weeks post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '-4.1', 'upperLimit': '4.3'}, {'value': '-0.8', 'groupId': 'OG001', 'lowerLimit': '-6.5', 'upperLimit': '10.2'}]}]}], 'analyses': [{'pValue': '0.78', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.94', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 10 weeks post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at entry and day 42), and 10 weeks after the fourth administration (at day 42)', 'description': 'Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at entry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline.', 'unitOfMeasure': 'percentage of CD8 cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 4 participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PTEF-b Phosphorylation (pNFKB+% and pS175%) in CD4+ T-cells in Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohorts 1-3 (Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG001', 'title': 'Cohorts 1-3 (Placebo for Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}], 'classes': [{'title': 'Change in pNFKB+% on CD4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '35.1'}, {'value': '19.3', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '39.1'}]}]}, {'title': 'Change in pS175% on CD4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '28.3'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '-3.5', 'upperLimit': '31.5'}]}]}], 'analyses': [{'pValue': '0.69', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in pNFKB+% on CD4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in pS175% on CD4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Hour 0 and 24 hours after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).\n\nChange was calculated as the value at 24 hours after the single administration of Romidepsin or placebo (at entry) minus the value at baseline.', 'unitOfMeasure': 'percentage of CD4 cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohorts 1-3 participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PTEF-b Phosphorylation (pNFKB+% and pS175%) in CD8+ T-cells in Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohorts 1-3 (Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'OG001', 'title': 'Cohorts 1-3 (Placebo for Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}], 'classes': [{'title': 'Change in pNFKB+% on CD8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '29'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '-8.3', 'upperLimit': '29.9'}]}]}, {'title': 'Change in pS175% on CD8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000', 'lowerLimit': '18.1', 'upperLimit': '38.8'}, {'value': '25.3', 'groupId': 'OG001', 'lowerLimit': '14.9', 'upperLimit': '37.2'}]}]}], 'analyses': [{'pValue': '0.81', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in pNFKB+% on CD8', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.81', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in pS175% on CD8', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Hour 0 and 24 hours after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).\n\nChange was calculated as the value at 24 hours after the single administration of Romidepsin or placebo (at entry) minus the value at baseline.', 'unitOfMeasure': 'percentage of CD8 cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohorts 1-3 participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PTEF-b Phosphorylation (pNFKB+%) in CD4+ T-cells in Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}, {'id': 'OG001', 'title': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}], 'classes': [{'title': 'Change from baseline to 24 hours post infusion 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.04', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8.63'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.01'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.78', 'groupId': 'OG000', 'lowerLimit': '4.77', 'upperLimit': '13.69'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.03'}]}]}, {'title': 'Change from baseline to 72 hours post infusion 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.39', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9.83'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.02'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.78', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '11.22'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.08'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.63', 'groupId': 'OG000', 'lowerLimit': '4.95', 'upperLimit': '11.74'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-0.01', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 2', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.28', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 72 hours post infusion 2', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 3', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-entry, entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14)', 'description': 'Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14) minus the value at baseline.', 'unitOfMeasure': 'percentage of CD4 cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 4 participants with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PTEF-b Phosphorylation (pS175+%) in CD4+ T-cells in Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}, {'id': 'OG001', 'title': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}], 'classes': [{'title': 'Change from baseline to 24 hours post infusion 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.93', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '17.06'}, {'value': '-0.01', 'groupId': 'OG001', 'lowerLimit': '-0.01', 'upperLimit': '0.01'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '12.87', 'upperLimit': '18.66'}, {'value': '-0.01', 'groupId': 'OG001', 'lowerLimit': '-0.01', 'upperLimit': '0'}]}]}, {'title': 'Change from baseline to 72 hours post infusion 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '15.36'}, {'value': '-0.01', 'groupId': 'OG001', 'lowerLimit': '-0.01', 'upperLimit': '0'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.85', 'groupId': 'OG000', 'lowerLimit': '5.29', 'upperLimit': '15.58'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-0.01', 'upperLimit': '0.05'}]}]}, {'title': 'Change from baseline to 24 hours post infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.52', 'groupId': 'OG000', 'lowerLimit': '6.82', 'upperLimit': '18.21'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.02'}]}]}], 'analyses': [{'pValue': '0.027', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 2', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 72 hours post infusion 2', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.022', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 3', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from baseline to 24 hours post infusion 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-entry, entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14)', 'description': 'Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14) minus the value at baseline.', 'unitOfMeasure': 'percentage of CD4 cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 4 participants with available data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1-Arm 1A (Romidepsin)', 'description': 'Participants in Cohort 1, Arm 1A received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'FG001', 'title': 'Cohort 2-Arm 2A (Romidepsin)', 'description': 'Participants in Cohort 2, Arm 2A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'FG002', 'title': 'Cohort 3-Arm 3A (Romidepsin)', 'description': 'Participants in Cohort 3, Arm 3A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'FG003', 'title': 'Cohorts 1-3 (Placebo for Romidepsin)', 'description': 'Participants in Cohorts 1-3, received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'FG004', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}, {'id': 'FG005', 'title': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Ineligible for subsequent study step', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '59', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1-Arm 1A (Romidepsin)', 'description': 'Participants in Cohort 1, Arm 1A received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'BG001', 'title': 'Cohort 2-Arm 2A (Romidepsin)', 'description': 'Participants in Cohort 2, Arm 2A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'BG002', 'title': 'Cohort 3-Arm 3A (Romidepsin)', 'description': 'Participants in Cohort 3, Arm 3A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'BG003', 'title': 'Cohorts 1-3 (Placebo for Romidepsin)', 'description': 'Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.'}, {'id': 'BG004', 'title': 'Cohort 4-Arm 4A (Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}, {'id': 'BG005', 'title': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': 'Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '59', 'groupId': 'BG006'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '55', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '59', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000', 'lowerLimit': '29', 'upperLimit': '54'}, {'value': '52', 'groupId': 'BG001', 'lowerLimit': '44', 'upperLimit': '54'}, {'value': '51', 'groupId': 'BG002', 'lowerLimit': '37', 'upperLimit': '58'}, {'value': '51', 'groupId': 'BG003', 'lowerLimit': '44', 'upperLimit': '56'}, {'value': '56', 'groupId': 'BG004', 'lowerLimit': '48', 'upperLimit': '61'}, {'value': '45', 'groupId': 'BG005', 'lowerLimit': '34', 'upperLimit': '53'}, {'value': '52', 'groupId': 'BG006', 'lowerLimit': '41', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '59', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '51', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White non-Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '59', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '35', 'groupId': 'BG006'}]}]}, {'title': 'Black non-Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '59', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}]}]}, {'title': 'Hispanic (regardless of race)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '59', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'Asian, Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '59', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '59', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '59', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline SCA in Cohorts 1-3', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '43', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'BG000', 'lowerLimit': '-0.13', 'upperLimit': '0.32'}, {'value': '-0.2', 'groupId': 'BG001', 'lowerLimit': '-0.49', 'upperLimit': '0.02'}, {'value': '0.22', 'groupId': 'BG002', 'lowerLimit': '-0.6', 'upperLimit': '0.57'}, {'value': '0.38', 'groupId': 'BG003', 'lowerLimit': '0.22', 'upperLimit': '0.51'}, {'value': 'NA', 'comment': 'Cohorts 1-3 and Cohort 4 were conducted as separate studies under the same study protocol. As such, all analyses were conducted separately for Cohorts 1-3 and Cohort 4.', 'groupId': 'BG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'description': 'Baseline HIV-1 RNA levels as detected by single copy assay (SCA) was calculated as the average of the pre-entry and entry SCA measurements for Cohorts 1-3', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Cohorts 1-3 were analyzed separately from Cohort 4'}, {'title': 'Baseline SCA in Cohort 4', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'BG004', 'lowerLimit': '-0.7', 'upperLimit': '0.39'}, {'value': '-0.25', 'groupId': 'BG005', 'lowerLimit': '-0.25', 'upperLimit': '0.31'}, {'value': 'NA', 'comment': 'Cohorts 1-3 and Cohort 4 were conducted as separate studies under the same study protocol. As such, all analyses were conducted separately for Cohorts 1-3 and Cohort 4.', 'groupId': 'BG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'description': 'Baseline HIV-1 RNA levels as detected by single copy assay (SCA) was calculated as the average of the pre-entry and entry SCA measurements for Cohort 4', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Cohorts 1-3 were analyzed separately from Cohort 4'}, {'title': 'Baseline CA RNA in Cohorts 1-3', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '43', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'BG000', 'lowerLimit': '1.7', 'upperLimit': '2.6'}, {'value': '2.6', 'groupId': 'BG001', 'lowerLimit': '2.3', 'upperLimit': '3'}, {'value': '2.3', 'groupId': 'BG002', 'lowerLimit': '2.0', 'upperLimit': '2.7'}, {'value': '2.8', 'groupId': 'BG003', 'lowerLimit': '2.4', 'upperLimit': '3'}, {'value': 'NA', 'comment': 'Cohorts 1-3 and Cohort 4 were conducted as separate studies under the same study protocol. As such, all analyses were conducted separately for Cohorts 1-3 and Cohort 4.', 'groupId': 'BG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'description': 'Baseline cell-associated HIV-1 RNA levels (CA-RNA) (log10 copies/mL) were measured in resting CD4 T-cells for Cohorts 1-3. Baseline CA-RNA is the pre-entry measurement for Cohorts 1-3.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Cohorts 1-3 were analyzed separately from Cohort 4'}, {'title': 'Baseline CA RNA in Cohort 4', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '1.19', 'groupId': 'BG004', 'lowerLimit': '0.9', 'upperLimit': '1.64'}, {'value': '1.61', 'groupId': 'BG005', 'lowerLimit': '1.49', 'upperLimit': '2.44'}, {'value': 'NA', 'comment': 'Cohorts 1-3 and Cohort 4 were conducted as separate studies under the same study protocol. As such, all analyses were conducted separately for Cohorts 1-3 and Cohort 4.', 'groupId': 'BG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'description': 'Baseline cell-associated HIV-1 RNA levels (CA-RNA) (log10 copies/mL) were measured in PBMCs for Cohort 4. Baseline CA-RNA was calculated as the average of the pre-entry and entry CA-RNA measurement for Cohort 4.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Cohorts 1-3 were analyzed separately from Cohort 4'}], 'populationDescription': 'All enrolled participants. The placebo arms of Cohorts 1-3 were combined for the Baseline Characteristics.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-07', 'size': 3244610, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-04-03T09:16', 'hasProtocol': True}, {'date': '2018-05-07', 'size': 1014318, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-03-15T13:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2018-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-28', 'studyFirstSubmitDate': '2013-08-28', 'resultsFirstSubmitDate': '2019-04-03', 'studyFirstSubmitQcDate': '2013-08-28', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-01', 'studyFirstPostDateStruct': {'date': '2013-09-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants With Grade 3 or Higher Adverse Events (AEs) in Cohorts 1-3 Romidepsin Arms', 'timeFrame': 'Measured from the time of Romidepsin administration (at entry) until 28 days after the administration', 'description': 'Proportion of participants with Grade 3 or higher adverse events (AEs) in Cohorts 1-3 Romidepsin Arms, including signs/symptoms, lab toxicities, and /or clinical events probably, possibly, or definitely related to study treatment (as judged by the core team, blinded to treatment arm). The DAIDS AE Grading Table (Version 1.0) was used.'}, {'measure': 'Proportion of Participants With Grade 3 or Higher Adverse Events (AEs) in Cohort 4 Romidepsin Arm', 'timeFrame': 'Measured from the time of the first Romidepsin administration through 28 days after the last administration (at day 42)', 'description': 'Proportion of participants with Grade 3 or Higher Adverse Events (AEs) in Cohort 4 Romidepsin Arm, including signs/symptoms, lab toxicities, and /or clinical events probably, possibly, or definitely related to study treatment (as judged by the core team, blinded to treatment arm). The DAIDS AE Grading Table (Version 1.0) was used.'}, {'measure': 'Change From Baseline in Plasma HIV-1 RNA Levels as Detected by Single Copy Assay in Cohorts 1-3', 'timeFrame': 'Pre-entry, entry, 24 and 48 hours after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the average of the pre-entry and entry values. Hour 24/48 is defined as the average of values at 24 and 48 hours after the single administration of Romidepsin or placebo (at study entry).\n\nChange was calculated as the value at hour 24/48 minus the value at baseline.'}, {'measure': 'Change From Baseline in Plasma HIV-1 RNA Levels as Detected by Single Copy Assay in Cohort 4', 'timeFrame': 'Pre-entry, entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)', 'description': 'Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) minus the value at baseline.'}, {'measure': 'Change From Baseline in Cell-associated HIV-1 RNA Levels in Resting CD4 T-cells in Cohorts 1-3', 'timeFrame': 'Pre-entry and 24 hours after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the pre-entry value. Change was calculated as the value at 24 hours after administration of Romidepsin or placebo (at entry) minus the value at baseline.'}, {'measure': 'Change From Baseline in Cell-associated HIV-1 RNA Levels in PBMCs in Cohort 4', 'timeFrame': 'Pre-entry, entry and 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)', 'description': 'Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) minus the value at baseline.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Plasma HIV-1 RNA Levels as Detected by Single Copy Assay in Cohorts 1-3', 'timeFrame': 'Pre-entry, entry, 6 hours, 12 hours, 7 days, 14 days and 28 days after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 6 hours, 12 hours, 7 days, 14 days and 28 days after administration of Romidepsin or placebo (at entry) minus the value at baseline.'}, {'measure': 'Change From Baseline in Plasma HIV-1 RNA Levels as Detected by Single Copy Assay in Cohort 4', 'timeFrame': 'Pre-entry, entry and 72 hours after the second administration of Romidepsin or placebo (at day 14)', 'description': 'Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 72 hours after the second administration of Romidepsin or placebo (at day 14) minus the value at baseline.'}, {'measure': 'Change From Baseline in Cell-associated HIV-1 RNA Levels in Resting CD4 T Cells in Cohorts 1-3', 'timeFrame': 'Pre-entry and 14 days after the administration of RMD or placebo (at entry)', 'description': 'Baseline is defined as the pre-entry value. Change was calculated as the value at 14 days after administration of Romidepsin or placebo (at entry) minus the value at baseline.'}, {'measure': 'Change From Baseline in Cell-associated HIV-1 RNA Levels in PBMCs in Cohort 4', 'timeFrame': 'Pre-entry and 72 hours after the second administration of Romidepsin or placebo (at day 14)', 'description': 'Baseline is defined as the pre-entry value. Change was calculated as the value at 72 hours after the second administration of Romidepsin or placebo (at day 14) minus the value at baseline.'}, {'measure': 'Change From Baseline in Histone Acetylation (Median FITC Ac-Histone) in CD3+ Cells in Cohorts 1-3', 'timeFrame': 'Hour 0 and 24 hours after the single administration of RMD or placebo (at entry)', 'description': 'Baseline is defined as the value at Hour 0, right before the single administration of Romidepsin or placebo.\n\nChange was calculated as the value at 24 hours after administration of Romidepsin or placebo (at entry) minus the value at baseline.\n\nMedian Fluorescent Intensity (MFI) data describes a shift in the expression of a fluorescently labeled marker on a population of cells. The reported MFI is an arbitrary value dependent on the voltage applied to the corresponding flow cytometer detector.'}, {'measure': 'Change From Baseline in Histone Acetylation in (Median FITC Ac-histone) in CD3+ Cells in Cohort 4', 'timeFrame': 'Entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42), and 72 hours after the second administration (at day 14)', 'description': 'Baseline is defined as the value right before the first administration of Romidepsin or placebo (at entry).\n\nChange was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration minus the value at baseline.\n\nMedian Fluorescent Intensity (MFI) data describes a shift in the expression of a fluorescently labeled marker on a population of cells. The reported MFI is an arbitrary value dependent on the voltage applied to the corresponding flow cytometer detector.'}, {'measure': 'Change From Baseline in Total HIV-1 DNA in Resting or Total CD4 T Cells in Cohorts 1-3', 'timeFrame': 'Pre-entry, 24 hours and 14 days after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the pre-entry value. Change was calculated as the value at 24 hours and 14 days after administration of Romidepsin or placebo (at entry) minus the value at baseline.'}, {'measure': 'Change From Baseline in Total HIV-1 DNA in PBMCs in Cohort 4', 'timeFrame': 'Pre-entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14)', 'description': 'Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration minus the value at baseline.'}, {'measure': 'PK Parameters for Romidepsin and Co-administered Antiretroviral Drugs (Efavirenz, Dolutegravir, or Raltegravir) in Cohorts 1-3', 'timeFrame': 'At hours 0, 4, 6, 12 and 24', 'description': 'Hour 0 is right before the single administration of Romidepsin or placebo (at entry).\n\nHour 4 is at the completion of Romidepsin or placebo administration. Hours 6, 12 and 24 are 2, 8 and 20 hours after the completion of Romidepsin or placebo administration.\n\nPK concentration (ng/mL) for Romidepsin at hours 0, 4, 6, 12 and 24. PK concentration (ng/mL) for co-administered antiretroviral drugs (Efavirenz \\[EFV\\], Dolutegravir \\[DTG\\], or Raltegravir \\[RAL\\]) at hours 0 and 24.'}, {'measure': 'PK Parameters for Romidepsin and Co-administered Antiretroviral Drugs (Dolutegravir or Raltegravi) in Cohort 4', 'timeFrame': 'Pre, post and 24 hours after the third and fourth administrations of Romidepsin or placebo (at days 28 and 42)', 'description': 'PK concentration (ng/mL) for Romidepsin pre and post the third and fourth administrations of Romidepsin or placebo.\n\nPK concentration (ng/mL) for co-administered antiretroviral drugs (Dolutegravir \\[DTG\\], or Raltegravir \\[RAL\\]) 24 hours after the third and fourth administrations of Romidepsin or placebo.'}, {'measure': 'HIV-1 RNA Levels in Cohorts 1-3', 'timeFrame': '7 days after the administration of Romidepsin or placebo (at entry)', 'description': 'HIV-1 RNA levels at 7 days after the single administration of Romidepsin or placebo (at entry)'}, {'measure': 'HIV-1 RNA Levels in Cohort 4', 'timeFrame': '7 days after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)', 'description': 'HIV-1 RNA levels at 7 days after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)'}, {'measure': 'Number of Participants With Reported Grade 2-4 AEs in Cohorts 1-3', 'timeFrame': 'Measured from study entry to off study', 'description': 'Number of participants with reported grade 2-4 adverse events including signs/symptoms, lab toxicities, and clinical events that are at least possibly related to study treatment. The DAIDS AE Grading Table (Version 1.0) was used.'}, {'measure': 'Number of Participants With Reported Grade 2-4 AEs in Cohort 4', 'timeFrame': 'Measured from study entry to off study', 'description': 'Number of participants with reported grade 2-4 adverse events including signs/symptoms, lab toxicities, and clinical events that are at least possibly related to study treatment. The DAIDS AE Grading Table (Version 1.0) was used.'}, {'measure': 'Change From Baseline in CD4+ and CD8+ T Cell Percent in Cohorts 1-3', 'timeFrame': "Measured through participant's last study visit", 'description': 'Change in CD4+ and CD8+T cell percent from baseline to after the single administration of Romidepsin or placebo'}, {'measure': 'Change From Baseline in CD4+ T Cell Percent in Cohort 4', 'timeFrame': 'Pre-entry, entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42), and 2, 5, 10 and 18 weeks after the fourth administration (at day 42)', 'description': 'Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours post each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 2, 5, 10 and 18 weeks post the fourth administration minus the value at baseline'}, {'measure': 'Change From Baseline in CD8+ T Cell Percent in Cohort 4', 'timeFrame': 'Measured through 28 days after the single administration of RMD or placebo (at entry, and days 14, 28 and 42)', 'description': 'Change in CD8+ T cell percent from baseline to after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)'}, {'measure': 'Change From Baseline in Cellular Markers of Immune Activation (CD38/HLA-DR Expression on CD4+ T-cells) in Cohorts 1-3', 'timeFrame': 'Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).\n\nChange was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo minus the value at baseline.'}, {'measure': 'Change From Baseline in Cellular Markers of Immune Activation (CD38/HLA-DR Expression on CD8+ T-cells) in Cohorts 1-3', 'timeFrame': 'Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).\n\nChange was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo minus the value at baseline.'}, {'measure': 'Change From Baseline in Cellular Markers of Immune Activation (CD69/CD25 Expression on CD4+ T-cells) in Cohorts 1-3', 'timeFrame': 'Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).\n\nChange was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo minus the value at baseline.'}, {'measure': 'Change From Baseline in Cellular Markers of Immune Activation (CD69/CD25 Expression on CD8+ T-cells) in Cohorts 1-3', 'timeFrame': 'Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).\n\nChange was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo minus the value at baseline.'}, {'measure': 'Change From Baseline in Cellular Markers of Immune Activation (CD38/HLA-DR Expression on CD4+ T-cells) in Cohort 4', 'timeFrame': 'Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at entry and day 42), and 10 weeks after the fourth administration (at day 42)', 'description': 'Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at entry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline.'}, {'measure': 'Change From Baseline in Cellular Markers of Immune Activation (CD38/HLA-DR Expression on CD8+ T-cells) in Cohort 4', 'timeFrame': 'Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at entry and day 42), and 10 weeks after the fourth administration (at day 42)', 'description': 'Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at entry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline.'}, {'measure': 'Change From Baseline in Cellular Markers of Immune Activation (CD69/CD25 Expression on CD4+ T-cells) in Cohort 4', 'timeFrame': 'Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at etnry and day 42), and 10 weeks after the fourth administration (at day 42)', 'description': 'Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at etnry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline.'}, {'measure': 'Change From Baseline in Cellular Markers of Immune Activation (CD69/CD25 Expression on CD8+ T-cells) in Cohort 4', 'timeFrame': 'Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at etnry and day 42), and 10 weeks after the fourth administration (at day 42', 'description': 'Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at etnry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline.'}, {'measure': 'Change From Baseline in Percentage of CD4+ T-cells Expressing Annexin V and/or 7 Amino-actinomycin D (7-AAD) in Cohorts 1-3', 'timeFrame': 'Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).\n\nChange was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry) minus the value at baseline.'}, {'measure': 'Change From Baseline in Percentage of CD8+ T-cells Expressing Annexin V and/or 7 Amino-actinomycin D (7-AAD) in Cohorts 1-3', 'timeFrame': 'Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).\n\nChange was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry) minus the value at baseline.'}, {'measure': 'Change From Baseline in Percentage of CD4+ T-cells Expressing Annexin V and/or 7 Amino-actinomycin D (7-AAD) in Cohort 4', 'timeFrame': 'Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at entry and day 42), and 10 weeks after the fourth administration (at day 42)', 'description': 'Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at entry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline.'}, {'measure': 'Change From Baseline in Percentage of CD8+ T-cells Expressing Annexin V and/or 7 Amino-actinomycin D (7-AAD) in Cohort 4', 'timeFrame': 'Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at entry and day 42), and 10 weeks after the fourth administration (at day 42)', 'description': 'Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at entry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline.'}, {'measure': 'Change From Baseline in PTEF-b Phosphorylation (pNFKB+% and pS175%) in CD4+ T-cells in Cohorts 1-3', 'timeFrame': 'Hour 0 and 24 hours after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).\n\nChange was calculated as the value at 24 hours after the single administration of Romidepsin or placebo (at entry) minus the value at baseline.'}, {'measure': 'Change From Baseline in PTEF-b Phosphorylation (pNFKB+% and pS175%) in CD8+ T-cells in Cohorts 1-3', 'timeFrame': 'Hour 0 and 24 hours after the single administration of Romidepsin or placebo (at entry)', 'description': 'Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).\n\nChange was calculated as the value at 24 hours after the single administration of Romidepsin or placebo (at entry) minus the value at baseline.'}, {'measure': 'Change From Baseline in PTEF-b Phosphorylation (pNFKB+%) in CD4+ T-cells in Cohort 4', 'timeFrame': 'Pre-entry, entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14)', 'description': 'Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14) minus the value at baseline.'}, {'measure': 'Change From Baseline in PTEF-b Phosphorylation (pS175+%) in CD4+ T-cells in Cohort 4', 'timeFrame': 'Pre-entry, entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14)', 'description': 'Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14) minus the value at baseline.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '15166525', 'type': 'BACKGROUND', 'citation': 'Ylisastigui L, Archin NM, Lehrman G, Bosch RJ, Margolis DM. Coaxing HIV-1 from resting CD4 T cells: histone deacetylase inhibition allows latent viral expression. AIDS. 2004 May 21;18(8):1101-8. doi: 10.1097/00002030-200405210-00003.'}, {'pmid': '18245545', 'type': 'BACKGROUND', 'citation': 'Klimek VM, Fircanis S, Maslak P, Guernah I, Baum M, Wu N, Panageas K, Wright JJ, Pandolfi PP, Nimer SD. Tolerability, pharmacodynamics, and pharmacokinetics studies of depsipeptide (romidepsin) in patients with acute myelogenous leukemia or advanced myelodysplastic syndromes. Clin Cancer Res. 2008 Feb 1;14(3):826-32. doi: 10.1158/1078-0432.CCR-07-0318.'}, {'pmid': '34398236', 'type': 'DERIVED', 'citation': 'McMahon DK, Zheng L, Cyktor JC, Aga E, Macatangay BJ, Godfrey C, Para M, Mitsuyasu RT, Hesselgesser J, Dragavon J, Dobrowolski C, Karn J, Acosta EP, Gandhi RT, Mellors JW. A Phase 1/2 Randomized, Placebo-Controlled Trial of Romidespin in Persons With HIV-1 on Suppressive Antiretroviral Therapy. J Infect Dis. 2021 Aug 16;224(4):648-656. doi: 10.1093/infdis/jiaa777.'}], 'seeAlsoLinks': [{'url': 'http://rsc.tech-res.com/clinical-research-sites/safety-reporting', 'label': 'DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 2.0, November 2014. Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010'}]}, 'descriptionModule': {'briefSummary': 'Antiretroviral therapy (ART) can reduce HIV to very low levels in the blood, but it cannot cure HIV infection because a small amount of virus remains in cells as a hidden (latent) form. The purpose of this study was to evaluate the safety and efficacy of single dose and multiple dose administration of romidepsin (RMD) in HIV-infected adults.', 'detailedDescription': 'A major challenge in eradicating HIV-1 infection is the persistence of virus in long-lived cells, such as latently infected memory CD4 T cells. One approach for eliminating the HIV-1 reservoir is to activate viral replication in these latently infected CD4 T cells by targeting cellular mechanisms that repress proviral transcription. Histone deacetylase inhibitors (HDACis), such as RMD, induce HIV-1 expression by increasing acetylation and facilitating transcriptional activation of HIV-1. RMD administered in combination with ART may serve as an important component of a strategy to eradicate the HIV-1 latent reservoir. The purpose of this study was to evaluate the safety and efficacy of single dose and multiple dose administration of RMD in HIV-infected adults.\n\nParticipants were sequentially enrolled into four cohorts and randomly assigned to receive either RMD or placebo. The cohorts differed in the dose of RMD given. Participants in Cohorts 1, 2, and 3 had one intravenous (IV) infusion of RMD or placebo at Day 0. Participants in Cohort 4 had four IV infusions of RMD or placebo at Days 0, 14, 28, and 42.\n\nFor participants in Cohorts 1, 2, and 3, study duration was 4 weeks. For participants in Cohort 4, study duration was a minimum of 24 weeks and a maximum of 48 weeks.\n\nParticipants attended several study visits, which could include a physical examination, blood and urine collection, pharmacokinetic (PK) sampling, and an electrocardiogram (ECG).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: Cohorts 1, 2, \\& 3\n\n* HIV-1 infection, documented by any licensed rapid HIV test or HIV E/CIA test kit at any time prior to study entry \\& confirmed by a licensed Western blot or a 2nd antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA\n* Receiving 2 (or more) nucleoside or nucleotide reverse transcriptase inhibitors with raltegravir, dolutegravir, or efavirenz for at least 90 days prior to study entry with no intention to change for the duration of the study\n* Documentation of at least 2 historical HIV-1 RNA measurements \\<50 copies/mL while on ART obtained by standard ultrasensitive assay. Documentation of the 1st measurement must be from a result obtained between 365-91 days, inclusive, prior to study entry. Documentation of the 2nd measurement must be from a result obtained between 730-366 days, inclusive, prior to study entry. In addition, there must be no HIV-1 RNA values ≥50 copies/mL for at least 365 days prior to study entry.\n* CD4 cell count ≥300 cells/mm\\^3 obtained within 90-50 days prior to study entry at any US laboratory that has a CLIA certification or equivalent\n* HIV-1 RNA level of \\<50 copies/mL obtained by standard ultrasensitive assay within 90-50 days prior to study entry\n* HIV-1 RNA level of ≥0.4 copies/mL obtained by SCA within 90-50 days prior to study entry. This result must be available prior to the pre-entry visit\n* The following laboratory values obtained within 21-0 days prior to study entry by any laboratory that has a CLIA certification or equivalent\n\n * ANC ≥1500 cells/mm\\^3\n * Hemoglobin ≥12.0 g/dL for men \\& \\>11.0 g/dL for women\n * Platelet count ≥120,000/mm\\^3\n* The following laboratory values obtained within 21-7 days prior to study entry by any laboratory that has a CLIA certification or equivalent\n\n * CrCl ≥60 mL/min\n * Potassium \\& magnesium within normal limits\n * AST (SGOT) \\<2.0 x ULN\n * ALT (SGPT) \\<2.0 x ULN\n * Alkaline phosphatase \\<2.0 x ULN\n * Total bilirubin \\<2.5 x ULN\n* HCV antibody negative result within 90-50 days prior to study entry or, for study candidates who are HCV antibody positive (based on testing performed at any time prior to study entry), a negative HCV RNA result obtained within 90-50 days prior to study entry\n* Negative HBsAg result obtained within 90-50 days prior to study entry or a positive HBsAb result at any time prior to study entry\n* For females of reproductive potential, negative serum or urine pregnancy test (latter with sensitivity of ≤25 mIU/mL) at the screening visit, pre-entry visit within 21-7 days prior to study entry, \\& at entry prior to romidepsin infusion, by any US laboratory that has a CLIA certification or equivalent\n* Female candidates of reproductive potential must refrain from participating in active attempts to become pregnant, \\&, if participating in sexual activity that could lead to pregnancy, must agree to use at least 2 reliable forms of contraception that are non-estrogen based. All female participants of reproductive potential must be instructed to use contraceptives for 6 months/180 days after completing RMD or placebo infusion\n* Karnofsky performance score ≥80 within 21-7 days prior to study entry\n* Men and women age ≥ 18 years\n* Ability \\& willingness to provide written informed consent\n* Investigator anticipates that a fully active alternative ART regimen could be constructed in the event of virologic failure on the current ART regimen\n\nExclusion Criteria: Cohorts 1, 2, \\& 3\n\n* History of or current malignancy requiring cytotoxic therapy\n* Bacterial, fungal, or viral infection (other than HIV) requiring systemic therapy within 30 days prior to entry\n* History of or current CMV end organ disease (eg, retinitis)\n* History of or current AIDS-related syndromes or symptoms that pose a perceived excessive risk for study drug-related morbidity, as determined by the investigator\n* Chronic, acute, or recurrent infections that are current \\& serious in the opinion of the investigator \\& for which the participant has not completed at least 14 consecutive days of therapy within 30 days prior to study entry and/or is not clinically stable\n* Active autoimmune disorders including but not limited to: inflammatory bowel diseases, scleroderma, severe psoriasis as determined by the investigator, systemic lupus erythematosus, rheumatoid arthritis \\& optic neuritis\n* History of seizure disorders\n* History of anticonvulsant use within 60 days prior to study entry\n* History of MI within 6 months prior to study entry, history of QTc prolongation (defined as ECG with QTc intervals \\>450 ms) at any time prior to study entry, NYHA class III or IV heart failure at any time prior to study entry, or family history of prolonged QTc syndrome\n* Breastfeeding\n* Use of immunomodulators (eg, interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 60 days prior to study entry\n* Any vaccination within 30 days prior to entry or intent to receive an elective vaccination (eg, flu shot, hepatitis A or B vaccine) during the course of the study\n* Intent to use cytokines (e.g., IL-2 or IL-12) during the course of the study. Prior administration of cytokines is not an exclusion criterion; however, at least 60 days between the most recent cycle of any cytokine and study entry is required\n* Within 60 days prior to study entry, use of systemic azole antifungals (voriconazole, itraconazole, ketoconazole); dexamethasone; macrolide antibiotics (azithromycin, clarithromycin, erythromycin); ARVs that are inhibitors of, or are metabolized by, CYP3A4 (atazanavir, ritonavir, nelfinavir, indinavir, saquinavir, darunavir, lopinavir, rilpivirine, maraviroc); cobicistat; warfarin; nefazodone; rifamycins (rifabutin, rifampin, rifapentine); St. John's Wort; carbamazepine; phenytoin; phenobarbital; amiodarone; dofetilide; pimozide; procainamide; quinidine; sotalol; \\& birth control products containing estrogen; drugs that are p-glycoprotein inhibitors; \\& drugs that prolong the QTc interval with a risk of Torsades de Pointes\n* Known allergy, sensitivity, or any hypersensitivity to components of RMD or its formulation\n* Use of histone deacetylase inhibitors (eg, vorinostat, valproic acid) at any time prior to study entry\n* Active illicit drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements\n* Acute or serious illness requiring systemic treatment and/or hospitalization that is not resolved within 30 days prior to entry\n* Psychosocial conditions that would prevent study compliance and follow-up, as determined by the investigator\n* Documented opportunistic infections within 60 days prior to entry\n\nInclusion Criteria: Cohort 4, Step 1\n\n* HIV-1 infection, documented by any licensed rapid HIV test or HIV E/CIA test kit at any time prior to study entry \\& confirmed by a licensed Western blot or a 2nd antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA\n* Receiving 2 or more nucleoside or nucleotide reverse transcriptase inhibitors with raltegravir or dolutegravir for at least 90 days prior to study entry with no intention to change for the duration of the study\n* Documentation of at least 2 historical HIV-1 RNA measurements \\<50 copies/mL while on ART obtained by standard ultrasensitive assay. Documentation of the first measurement must be from a result obtained between 365-61 days, inclusive, prior to study entry. Documentation of the second measurement must be from a result obtained between 730-366 days, inclusive, prior to study entry. In addition, there must be no HIV-1 RNA values ≥50 copies/mL for at least 365 days prior to study entry\n* CD4 cell count ≥300 cells/mm\\^3 obtained between 36-60 days prior to study entry (screening visit) at any US laboratory that has a CLIA certification or equivalent\n* HIV-1 RNA level of \\<50 copies/mL obtained by standard ultrasensitive assay at screening (between 36-60 days prior to study entry)\n* The following laboratory values obtained at pre-entry (between 3-14 days prior to study entry) by any laboratory that has a CLIA certification or equivalent\n\n * ANC ≥1500 cells/mm\\^3\n * Hemoglobin ≥12.0 g/dL for men \\& \\>11.0 g/dL for women\n * Platelet count ≥120,000/mm\\^3\n * CrCl ≥60 mL/min\n * Potassium \\& magnesium within normal limits\n * AST (SGOT) \\<2.0 x ULN\n * ALT (SGPT) \\<2.0 x ULN\n * Alkaline phosphatase \\<2.0 x ULN\n * Total bilirubin \\<2.5 x ULN\n* HCV antibody negative result at screening (between 36-60 days prior to study entry) or, for study candidates who are HCV antibody positive (based on testing performed at any time prior to study entry), a negative HCV RNA result obtained at screening\n* Negative HBsAg result obtained at screening (between 36-60 days prior to study entry) or a positive HBsAb result at any time prior to study entry\n* For females of reproductive potential, negative urine pregnancy test (with a sensitivity of ≤25 mIU/mL) at screening (between 36-60 days prior to study entry), at pre-entry (between 3-14 days prior to study entry), \\& at entry prior to infusion, by any US laboratory that has a CLIA certification or equivalent\n* Female candidates of reproductive potential must refrain from participating in active attempts to become pregnant, \\&, if participating in sexual activity that could lead to pregnancy, must agree to use at least 2 reliable forms of contraception that are non-estrogen based. All participants of reproductive potential will be instructed to use contraceptives for 6 months or 180 days after completing RMD/placebo infusion\n* Karnofsky performance score ≥80 at pre-entry (between 3-14 days prior to study entry)\n* Men and women age ≥ 18 years\n* Ability \\& willingness to provide written informed consent\n* Investigator anticipates that a fully active alternative ART regimen could be constructed in the event of virologic failure on the current ART regimen\n\nExclusion Criteria: Cohort 4, Step 1\n\n* History of or current malignancy requiring cytotoxic therapy\n* Bacterial, fungal or viral infection (other than HIV) requiring systemic therapy within 30 days prior to entry\n* History of or current CMV end organ disease (eg, retinitis)\n* History of or current AIDS-related syndromes or symptoms that pose a perceived excessive risk for study drug-related morbidity, as determined by the investigator\n* Chronic, acute, or recurrent infections that are current \\& serious, in the opinion of the investigator, for which the participant has not completed at least 14 consecutive days of therapy within 30 days prior to study entry and/or is not clinically stable\n* Active autoimmune disorders including but not limited to inflammatory bowel diseases, scleroderma, severe psoriasis as determined by the investigator, systemic lupus erythematosus, rheumatoid arthritis, \\& optic neuritis\n* History of seizure disorders\n* History of anticonvulsant use within 60 days prior to study entry\n* History of MI within 6 months prior to study entry, history of QTc prolongation (defined as ECG with QTc intervals \\>450 ms) at any time prior to study entry, NYHA class III or IV heart failure at any time prior to study entry, or family history of prolonged QTc syndrome\n* Breastfeeding\n* Use of immunomodulators (eg, interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 60 days prior to study entry\n* Any vaccination within 30 days prior to entry or intent to receive an elective vaccination (eg, flu shot, hepatitis A or B vaccine) during the course of the study\n* Intent to use cytokines (eg, IL-2 or IL-12) during the course of the study\n* Within 60 days prior to study entry, use of systemic azole antifungals (voriconazole, itraconazole, ketoconazole), dexamethasone, macrolide antibiotics (azithromycin, clarithromycin, erythromycin), antiretrovirals that are inhibitors of, or are metabolized by CYP3A4 (atazanavir, ritonavir, nelfinavir, indinavir, saquinavir, darunavir, lopinavir, rilpivirine, maraviroc), cobicistat, warfarin, nefazodone, rifamycins (rifabutin, rifampin, rifapentine), St. John's Wort, carbamazepine, phenytoin, phenobarbital, amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, \\& birth control products containing estrogen, drugs that are p-glycoprotein inhibitors, \\& drugs that prolong the QTc interval with a risk of Torsades de Pointes\n* Known allergy/sensitivity or any hypersensitivity to components of RMD or its formulation\n* Use of histone deacetylase inhibitors (eg, vorinostat, valproic acid) at any time prior to study entry\n* Active illicit drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements\n* Acute or serious illness requiring systemic treatment and/or hospitalization that is not resolved within 30 days prior to entry\n* Psychosocial conditions that would prevent study compliance \\& follow-up as determined by the investigator\n* Documented opportunistic infections within 60 days prior to entry\n* Use of any of the medications listed in the Prohibited Medications table in the protocol\n\nSee the protocol for Inclusion and Exclusion Criteria for Cohort 4, Steps 2, 3, and 4."}, 'identificationModule': {'nctId': 'NCT01933594', 'briefTitle': 'Evaluating the Safety and Efficacy of Romidepsin in Combination With Antiretroviral Therapy in HIV-Infected Adults With Suppressed Viral Load', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Phase I/II Study of Romidepsin in HIV-Infected Adults With Suppressed Viremia on Antiretroviral Therapy to Assess Safety, Tolerability, and Activation of HIV-1 Expression', 'orgStudyIdInfo': {'id': 'A5315'}, 'secondaryIdInfos': [{'id': '11892', 'type': 'REGISTRY', 'domain': 'DAIDS-ES'}, {'id': 'ACTG 5315'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1-Arm 1A (Romidepsin)', 'description': "Participants in Cohort 1, Arm 1A received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit. Dose of Romidepsin was 0.5 mg/m\\^2, with total dose based on the participant's body surface area (determined by participant's height and weight).", 'interventionNames': ['Drug: Romidepsin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 1-Arm 1B (Placebo for Romidepsin)', 'description': "Participants in Cohort 1, Arm 1B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit. Dose of sodium chloride for injection placebo was 0.5 mg/m\\^2, with total dose based on the participant's body surface area (determined by participant's height and weight).", 'interventionNames': ['Drug: Placebo for Romidepsin']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2-Arm 2A (Romidepsin)', 'description': "Participants in Cohort 2, Arm 2A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit. Dose of Romidepsin was 2 mg/m\\^2, with total dose based on the participant's body surface area (determined by participant's height and weight).", 'interventionNames': ['Drug: Romidepsin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 2-Arm 2B (Placebo for Romidepsin)', 'description': "Participants in Cohort 2, Arm 2B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit. Dose of sodium chloride for injection placebo was 2 mg/m\\^2, with total dose based on the participant's body surface area (determined by participant's height and weight).", 'interventionNames': ['Drug: Placebo for Romidepsin']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3-Arm 3A (Romidepsin)', 'description': "Participants in Cohort 3, Arm 3A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit. Dose of Romidepsin was 5 mg/m\\^2, with total dose based on the participant's body surface area (determined by participant's height and weight).", 'interventionNames': ['Drug: Romidepsin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 3-Arm 3B (Placebo for Romidepsin)', 'description': "Participants in Cohort 3, Arm 3B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit. Dose of sodium chloride for injection placebo was 5 mg/m\\^2, with total dose based on the participant's body surface area (determined by participant's height and weight).", 'interventionNames': ['Drug: Placebo for Romidepsin']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4-Arm 4A (Romidepsin)', 'description': "Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits. Dose of Romidepsin was 5 mg/m\\^2, with total dose based on the participant's body surface area (determined by participant's height and weight).", 'interventionNames': ['Drug: Romidepsin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 4-Arm 4B (Placebo for Romidepsin)', 'description': "Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits. Dose of sodium chloride for injection placebo was 5 mg/m\\^2, with total dose based on the participant's body surface area (determined by participant's height and weight).", 'interventionNames': ['Drug: Placebo for Romidepsin']}], 'interventions': [{'name': 'Romidepsin', 'type': 'DRUG', 'otherNames': ['RMD', 'Istodax'], 'description': 'RMD administered over 4 hours via an intravenous (IV) catheter.', 'armGroupLabels': ['Cohort 1-Arm 1A (Romidepsin)', 'Cohort 2-Arm 2A (Romidepsin)', 'Cohort 3-Arm 3A (Romidepsin)', 'Cohort 4-Arm 4A (Romidepsin)']}, {'name': 'Placebo for Romidepsin', 'type': 'DRUG', 'otherNames': ['0.9% NaCl', '0.9% sodium chloride'], 'description': 'Placebo for RMD administered over 4 hours via an IV catheter.', 'armGroupLabels': ['Cohort 1-Arm 1B (Placebo for Romidepsin)', 'Cohort 2-Arm 2B (Placebo for Romidepsin)', 'Cohort 3-Arm 3B (Placebo for Romidepsin)', 'Cohort 4-Arm 4B (Placebo for Romidepsin)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama CRS', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90035', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA CARE Center CRS', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital CRS', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital CRS (MGH CRS)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Adult HIV Therapeutic Strategies Network CRS', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Chapel Hill CRS', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University CRS', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn Therapeutics, CRS', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh CRS', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '98104-9929', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington AIDS CRS', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'John Mellors, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Pittsburgh'}, {'name': 'Deborah McMahon, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}