Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-29 @ 9:17 PM
Study NCT ID:
NCT00078403
Status:
COMPLETED
Last Update Posted:
2021-11-08
First Post:
2004-02-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D008107', 'term': 'Liver Diseases'}], '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'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, '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 Trial 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 US or foreign patent or other intellectual property rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "From entry (Step 2 for Arms A and B, Step 3 for Arm C) to study completion (at Week 72 for Step 2; at week 78-84 for Step 3, depending on participants' time in Step 1).", 'description': 'The protocol required reporting of signs/symptoms and laboratory results \\>=Grade 3 and events that led to a change in treatment, regardless of grade. Hemoglobin, plateles, ANC, fasting HDL, LDL and total cholesterol, insulin and glucose values were reported regardless of grade. The DAIDS AE Grading Table (1992) and Expedited AE Manual (2004) were used.', 'eventGroups': [{'id': 'EG000', 'title': 'Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to be HCV RNA positive (HCV RNA \\> 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to receive the pegylated interferon (PEG-IFN) 180 mcg weekly Arm.', 'otherNumAtRisk': 44, 'otherNumAffected': 43, 'seriousNumAtRisk': 44, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'OL (PEG-IFN, RBV) Then OL Randomized (Observation)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to be HCV RNA positive (HCV RNA \\> 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to be followed on the Observation (no treatment) Arm.', 'otherNumAtRisk': 42, 'otherNumAffected': 41, 'seriousNumAtRisk': 42, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)', 'description': 'At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA \\< 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly \\& ribavirin \\[RBV\\] 1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA \\> 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.', 'otherNumAtRisk': 169, 'otherNumAffected': 166, 'seriousNumAtRisk': 169, 'seriousNumAffected': 37}], 'otherEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 64}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood glucose abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 55}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood triglycerides abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 144}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 58}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Prothrombin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Bone marrow failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': "Basedow's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Neutrophil count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cerebellar tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.'}, {'id': 'OG001', 'title': 'B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).'}, {'id': 'OG002', 'title': 'C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)', 'description': 'At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \\<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \\& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \\>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1.37'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'analyses': [{'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is pre-specified 1-sided test that PEG slows liver fibrosis progression. Accrual and follow-up on Arms A and B were halted at interim review for lack of fibrosis progression in Arm B (control arm). P-value is unadjusted for interim analysis.', 'groupDescription': 'Accrual and follow-up on Arms A and B were halted for futility at the first independent interim review of the primary endpoint conducted on May 2, 2007.', 'statisticalMethod': 'Exact Wilcoxon rank sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and at week 72 or premature discontinuation', 'description': 'SCMFS is the difference between the Metavir fibrosis scores of the study exit and study entry liver biopsies where the difference is scaled to one year. The SCMFS assesses the annualized change in the severity of liver fibrosis on a continuous scale from -4.0 Metavir units per year (reduced fibrosis over time, a positive study outcome) to +4.0 Metavir units per year (increased fibrosis over time).', 'unitOfMeasure': 'Metavir units per one year (52 weeks)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '62 Arm A and B participants who had follow-up liver biopsy performed or those who had Week 72 potential as of May 2, 2007 but no follow-up liver biopsy. In the unadjusted ITT analysis, the participants without SCMFS available were assigned the highest SCMFS (+2).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.'}, {'id': 'OG001', 'title': 'B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).'}, {'id': 'OG002', 'title': 'C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)', 'description': 'At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \\<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \\& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \\>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.'}], 'classes': [{'title': 'Week 0--Number of participants with HCV RNA data', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}]}, {'title': 'Week 0--Number of participants with detectable HCV', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}]}, {'title': 'Week 12--Number of participants with HCV RNA data', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '158', 'groupId': 'OG002'}]}]}, {'title': 'Week 12-Number of participants with detectable HCV', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'Week 24--Number of participants with HCV RNA data', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}]}, {'title': 'Week 24-Number of participants with detectable HCV', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'Week 36--Number of participants with HCV RNA data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '158', 'groupId': 'OG002'}]}]}, {'title': 'Week 36-Number of participants with detectable HCV', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Test not specified in protocol at this time point.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Test not specified in protocol at this time point.', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}, {'title': 'Week 48--Number of participants with HCV RNA data', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 48-Number of participants with detectable HCV', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Test not specified in protocol at this time point.', 'groupId': 'OG002'}]}]}, {'title': 'Week 60--Number of participants with HCV RNA data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}]}]}, {'title': 'Week 60-Number of participants with detectable HCV', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Test not specified in protocol at this time point.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Test not specified in protocol at this time point.', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'Week 72--Number of participants with HCV RNA data', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}]}]}, {'title': 'Week 72-Number of participants with detectable HCV', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}, {'title': 'Week 84--Number of participants with HCV RNA data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}]}]}, {'title': 'Week 84-Number of participants with detectable HCV', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Test not specified in protocol at this time point.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Test not specified in protocol at this time point.', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Arms A and B: Weeks 0, 12, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 60, 72, 84', 'description': 'Qualitative plasma HCV viral load was categorized as less than 60 IU/mL vs greater than or equal to 60 IU/mL where 60 IU/mL is the lower limit of qualitative assay used in Steps 2 and 3.', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'All Arm A, B and C participants'}, {'type': 'SECONDARY', 'title': 'Time-scaled Change in Ishak Liver Inflammation Score (SCIIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.'}, {'id': 'OG001', 'title': 'B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).'}, {'id': 'OG002', 'title': 'C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)', 'description': 'At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \\<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \\& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \\>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-0.75', 'upperLimit': '1.79'}, {'value': '1.31', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2.10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and at week 72 or premature discontinuation', 'description': 'Liver biopsies were performed within 42 days prior to randomization between Arms A and B while the participant remained on PEG-IFN plus RBV (=entry biopsy) and again at week 72 or premature study discontinuation (=exit biopsy). SCIIS was defined as the difference between the Ishak inflammation score of the exit biopsy and the Ishak inflammation score of the entry biopsy, where the difference is scaled to one year.', 'unitOfMeasure': 'Ishak units per one year (52 weeks)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with SCIIS available (Complete Cases)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.'}, {'id': 'OG001', 'title': 'B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).'}, {'id': 'OG002', 'title': 'C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)', 'description': 'At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \\<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \\& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \\>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.'}], 'classes': [{'title': 'Anemia >= Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 96 weeks', 'description': 'Number of participants with anemia by grade (defined by hemoglobin level in grams per deciliter; g/dL). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = hemoglobin of 8 to 9.4 g/dl; Grade 2 = 7 to 7.9 g/dl; Grade 3 = 6.5 to 6.9 g/dl; Grade 4 = below 6.5 g/dl.', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'All Arm A, B and C participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Neutropenia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.'}, {'id': 'OG001', 'title': 'B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).'}, {'id': 'OG002', 'title': 'C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)', 'description': 'At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \\<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \\& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \\>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.'}], 'classes': [{'title': 'Neutropenia >= Grade 2', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 96 weeks', 'description': 'Number of participants with neutropenia by grade (defined by absolute neutrophil count \\[ANC\\] per cubic millimeter; mm\\^3). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = ANC of 1000 to 1500 /mm\\^3; Grade 2 = 750 to 999 /mm\\^3; Grade 3 = 500 to 749 /mm\\^3; Grade 4 = below 500 /mm\\^3.', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'All Arm A, B and C participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Thrombocytopenia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.'}, {'id': 'OG001', 'title': 'B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).'}, {'id': 'OG002', 'title': 'C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)', 'description': 'At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \\<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \\& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \\>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.'}], 'classes': [{'title': 'Thrombocytopenia >= Grade 2', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 96 weeks', 'description': 'Number of participants with thrombocytopenia by grade (defined by platelet count per cubic millimeter; mm\\^3). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = platelets of 75,000 to 99,000 /mm\\^3; Grade 2 = 50,000 to 74,999 /mm\\^3; Grade 3 = 20,000 to 49,999 /mm\\^3; Grade 4 = below 20,000 /mm\\^3.', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'All Arm A, B and C participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Depression and/or Other Psychological Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.'}, {'id': 'OG001', 'title': 'B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).'}, {'id': 'OG002', 'title': 'C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)', 'description': 'At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \\<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \\& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \\>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.'}], 'classes': [{'title': 'Any psychological', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 96 weeks', 'description': 'Depression and other psychological events. DAIDS Toxicity Grading Table (1992) was used for grading. The protocol required reporting of depression and other psychological events of Grade 3 or higher or if led to a change in treatment, regardless of grade.', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'All Arm A, B and C participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With High-grade Signs and Symptoms or Laboratory Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.'}, {'id': 'OG001', 'title': 'B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).'}, {'id': 'OG002', 'title': 'C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)', 'description': 'At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \\<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \\& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \\>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.'}], 'classes': [{'title': 'Any Grade 3 or higher', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 96 Weeks', 'description': 'Number of participants with high-grade (Grade 3 or higher) signs and symptoms or laboratory values. DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = transient/mild discomfort, no limitation in activity, no medical intervention; Grade 2 = mild/moderate limitation in activity, some assistance, no/minimal medical intervention; Grade 3 = marked limitation in activity, some assistance, medical intervention required); Grade 4 = extreme limitation in activity, significant medical intervention, assistance, hospitalization.', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'All Arm A, B and C participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.'}, {'id': 'OG001', 'title': 'B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).'}, {'id': 'OG002', 'title': 'C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)', 'description': 'At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \\<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \\& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \\>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.'}], 'classes': [{'title': 'Premature treatment discontinuation', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG002'}]}]}, {'title': 'Temporarily off treatment', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'Reduced dose', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 96 Weeks', 'description': '3-level categorical of the worst of 1) premature treatment discontinuation, 2) temporary stop or 3) dose reduction. For Arm C, the worst for either PEG-IFN or RBV is summarized.', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'All Arm A and C participants. Arm B participants did not receive treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Adherent to Study Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.'}, {'id': 'OG001', 'title': 'B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).'}, {'id': 'OG002', 'title': 'C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)', 'description': 'At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \\<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \\& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \\>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.'}], 'classes': [{'title': 'Week 0: Number of participants with adherence data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG002'}]}]}, {'title': 'Week 0: Number of participants adherent to meds', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Evaluation not specified in protocol at this timepoint.', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG002'}]}]}, {'title': 'Week 12:Number of participants with adherence data', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG002'}]}]}, {'title': 'Week 12:Number of participants adherent to meds', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG002'}]}]}, {'title': 'Week 24:Number of participants with adherence data', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG002'}]}]}, {'title': 'Week 24:Number of participants adherent to meds', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG002'}]}]}, {'title': 'Week 48:Number of participants with adherence data', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG002'}]}]}, {'title': 'Week 48:Number of participants adherent to meds', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG002'}]}]}, {'title': 'Week 60:Number of participants with adherence data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG002'}]}]}, {'title': 'Week 60:Number of participants adherent to meds', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Evaluation not specified in protocol at this timepoint.', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG002'}]}]}, {'title': 'Week 72:Number of participants with adherence data', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 72:Number of participants adherent to meds', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Evaluation not specified in protocol at this timepoint.', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Arm A: at weeks 12, 24, 48 and 72. Arm C: at entry and weeks 12, 24, 48, 60.', 'description': "A categorical variable with levels adherent and non-adherent based on participants' self report. For Arm A, adherence was defined as not missing PEG within 2 weeks of visit. For Arm C, adherence was defined as not missing any PEG within 2 weeks of visit and not missing RBV within 4 days of visit.", 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'All Arm A and Arm C participants. Arm B participants did not receive treatment.'}, {'type': 'SECONDARY', 'title': 'HCV Polymorphisms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.'}, {'id': 'OG001', 'title': 'B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).'}], 'timeFrame': 'Entry and week 72 (Arms A and B only).', 'description': 'Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued. No participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'HCV-specific Immune Response in Intrahepatic Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.'}, {'id': 'OG001', 'title': 'B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).'}], 'timeFrame': 'Entry and week 72 (Arms A and B only).', 'description': 'Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued. No participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.'}, {'id': 'OG001', 'title': 'B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).'}, {'id': 'OG002', 'title': 'C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)', 'description': 'At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \\<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \\& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \\>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.'}], 'classes': [{'title': 'Week 0: Number of participants with HIV RNA data', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}]}, {'title': 'Week 0: No. of participants with undetectable VL', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}]}, {'title': 'Week 12: Number of participants with HIV RNA data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}]}, {'title': 'Week 12: No. of participants with undetectable VL', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Test not specified in protocol at this timepoint.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Test not specified in protocol at this timepoint.', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}]}, {'title': 'Week 24: Number of participants with HIV RNA data', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}]}, {'title': 'Week 24: No. of participants with undetectable VL', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}]}, {'title': 'Week 36: Number of participants with HIV RNA data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}]}]}, {'title': 'Week 36: No. of participants with undetectable VL', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Test not specified in protocol at this timepoint.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Test not specified in protocol at this timepoint.', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}]}]}, {'title': 'Week 48: Number of participants with HIV RNA data', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}]}, {'title': 'Week 48: No. of participants with undetectable VL', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}]}, {'title': 'Week 60: Number of participants with HIV RNA data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}]}, {'title': 'Week 60: No. of participants with undetectable VL', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Test not specified in protocol at this timepoint.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Test not specified in protocol at this timepoint.', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}]}, {'title': 'Week 72: Number of participants with HIV RNA data', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}]}, {'title': 'Week 72: No. of participants with undetectable VL', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}]}, {'title': 'Week 84: Number of participants with HIV RNA data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}]}]}, {'title': 'Week 84: No. of participants with undetectable VL', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Test not specified in protocol at this timepoint.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Test not specified in protocol at this timepoint.', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Arms A and B: Weeks 0, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 48, 60, 72, 84', 'description': 'A blood sample was drawn to determine the HIV-1 viral load. HIV-1 viral load was categorized as \\<50 copies/mL (undetectable) or \\>=50 copies/mL (detectable). 50 is the lower limit of detection of the assay.', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'All Arm A, B, and C participants'}, {'type': 'SECONDARY', 'title': 'Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.'}, {'id': 'OG001', 'title': 'B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).'}, {'id': 'OG002', 'title': 'C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)', 'description': 'At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \\<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \\& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \\>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.'}], 'classes': [{'title': 'Week 0: HOMA-IR (N=32 in A, 32 in B, 72 in C)', 'categories': [{'measurements': [{'value': '3.84', 'groupId': 'OG000', 'lowerLimit': '2.77', 'upperLimit': '9.03'}, {'value': '2.49', 'groupId': 'OG001', 'lowerLimit': '1.83', 'upperLimit': '4.48'}, {'value': '2.37', 'groupId': 'OG002', 'lowerLimit': '1.50', 'upperLimit': '5.36'}]}]}, {'title': 'Week 12: HOMA-IR (N=72 in C)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'HOMA-IR was not collected at Week 12 in Arms A and B.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'HOMA-IR was not collected at Week 12 in Arms A and B.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.47', 'groupId': 'OG002', 'lowerLimit': '1.63', 'upperLimit': '4.22'}]}]}, {'title': 'Week 24: HOMA-IR (N=34 in A, 30 in B, 73 in C)', 'categories': [{'measurements': [{'value': '3.08', 'groupId': 'OG000', 'lowerLimit': '1.68', 'upperLimit': '5.59'}, {'value': '4.78', 'groupId': 'OG001', 'lowerLimit': '1.78', 'upperLimit': '6.13'}, {'value': '2.58', 'groupId': 'OG002', 'lowerLimit': '1.35', 'upperLimit': '4.44'}]}]}, {'title': 'Week 36: HOMA-IR (N=66 in C)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'HOMA-IR was not collected at Week 36 in Arms A and B.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'HOMA-IR was not collected at Week 36 in Arms A and B.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.41', 'groupId': 'OG002', 'lowerLimit': '1.44', 'upperLimit': '4.58'}]}]}, {'title': 'Week 48: HOMA-IR (N=30 in A, 24 in B, 74 in C)', 'categories': [{'measurements': [{'value': '3.53', 'groupId': 'OG000', 'lowerLimit': '1.72', 'upperLimit': '6.65'}, {'value': '2.84', 'groupId': 'OG001', 'lowerLimit': '1.78', 'upperLimit': '6.38'}, {'value': '3.25', 'groupId': 'OG002', 'lowerLimit': '1.73', 'upperLimit': '5.01'}]}]}, {'title': 'Week 72: HOMA-IR (N=67 in C)', 'categories': [{'measurements': [{'value': '4.79', 'groupId': 'OG000', 'lowerLimit': '3.41', 'upperLimit': '7.83'}, {'value': '4.82', 'groupId': 'OG001', 'lowerLimit': '2.46', 'upperLimit': '9.12'}, {'value': '2.69', 'groupId': 'OG002', 'lowerLimit': '1.66', 'upperLimit': '5.47'}]}]}, {'title': 'Week 84: HOMA-IR (N=63 in C)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'HOMA-IR was not collected at Week 84 in Arms A and B.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'HOMA-IR was not collected at Week 84 in Arms A and B.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.99', 'groupId': 'OG002', 'lowerLimit': '1.66', 'upperLimit': '4.98'}]}]}, {'title': 'Week 96: HOMA-IR (N=65 in C)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'HOMA-IR was not collected at Week 96 in Arms A and B.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'HOMA-IR was not collected at Week 96 in Arms A and B.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.30', 'groupId': 'OG002', 'lowerLimit': '1.63', 'upperLimit': '4.15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Arms A and B: at entry and weeks 24, 48 and 72; Arm C: at entry and at weeks 12, 24, 36, 48, 72, 84 and 96.', 'description': 'Insulin resistance was evaluated by HOMA-IR, calculated as \\[fasting glucose (mg/dL) x fasting insulin (uIU/mL)\\]/405. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin and fasting glucose testing.', 'unitOfMeasure': 'mg/dL x uIU/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All Arm A, B and C participants who had HOMA-IR result available. In Arm C, metabolic testing was only performed on participants who enrolled under protocol version 1.0. The number of participants with results available at time points listed in the Time Frame are shown in the Data Table Row Titles below.'}, {'type': 'SECONDARY', 'title': 'Sustained Virologic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.'}, {'id': 'OG001', 'title': 'B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).'}, {'id': 'OG002', 'title': 'C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)', 'description': 'At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \\<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \\& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \\>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks after end of treatment', 'description': 'Sustained Virologic Response (SVR) was defined as undetectable HCV viral load (\\<60 IU/ml) 24 weeks after treatment discontinuation.', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'All Arm A, B and C participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Used Antianorexia Agents, Such as Megestrol and Dronabinol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.'}, {'id': 'OG001', 'title': 'B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).'}, {'id': 'OG002', 'title': 'C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)', 'description': 'At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \\<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \\& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \\>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation..'}], 'classes': [{'title': 'Number of participants who used megestrol', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Number of participants who used dronabinol', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 96 weeks', 'description': 'Use of antianorexia agents, such as megestrol and dronabinol at any time after pre-assignment.', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'All Arm A, B and C participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Prescription as Needed of Erythropoietin (EPO), Granulocyte Colony-stimulating Factor (GCSF), and Granulocyte-monocyte Colony-stimulating Factor (GM-CSF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.'}, {'id': 'OG001', 'title': 'B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).'}, {'id': 'OG002', 'title': 'C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)', 'description': 'At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \\<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \\& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \\>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.'}], 'classes': [{'title': 'Number of participants who used EPO', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}]}, {'title': 'Number of participants who used GCSF', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}, {'title': 'Number of participants who used GM-CSF', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At any time after pre-assignment', 'description': 'Prescription as needed of hematologic adjuvant therapies: erythropoietin (EPO), granulocyte colony-stimulating factor (GCSF), and granulocyte-monocyte colony-stimulating factor (GM-CSF) any time after pre-assignment', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'All Arm A, B and C participants'}, {'type': 'SECONDARY', 'title': 'Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.'}, {'id': 'OG001', 'title': 'B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).'}, {'id': 'OG002', 'title': 'C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)', 'description': 'At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \\<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \\& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \\>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.'}], 'classes': [{'title': 'Week 0: Weight (N=43 in A, 42 in B, 169 in C)', 'categories': [{'measurements': [{'value': '74.9', 'groupId': 'OG000', 'lowerLimit': '67.6', 'upperLimit': '86.8'}, {'value': '79.8', 'groupId': 'OG001', 'lowerLimit': '69.7', 'upperLimit': '88.3'}, {'value': '75.8', 'groupId': 'OG002', 'lowerLimit': '68.6', 'upperLimit': '84.4'}]}]}, {'title': 'Week 4: Weight (N=43 in A, 35 in B, 161 in C)', 'categories': [{'measurements': [{'value': '74.7', 'groupId': 'OG000', 'lowerLimit': '68.6', 'upperLimit': '87.4'}, {'value': '80.4', 'groupId': 'OG001', 'lowerLimit': '70.5', 'upperLimit': '88.5'}, {'value': '75.8', 'groupId': 'OG002', 'lowerLimit': '68.3', 'upperLimit': '83.5'}]}]}, {'title': 'Week 8: Weight (N=39 in A, 34 in B, 162 in C)', 'categories': [{'measurements': [{'value': '74.9', 'groupId': 'OG000', 'lowerLimit': '66.7', 'upperLimit': '87.3'}, {'value': '80.8', 'groupId': 'OG001', 'lowerLimit': '71.8', 'upperLimit': '90.9'}, {'value': '75.8', 'groupId': 'OG002', 'lowerLimit': '67.6', 'upperLimit': '84.9'}]}]}, {'title': 'Week 12: Weight (N=42 in A, 30 in B, 157 in C)', 'categories': [{'measurements': [{'value': '76.3', 'groupId': 'OG000', 'lowerLimit': '67.2', 'upperLimit': '87.9'}, {'value': '81.1', 'groupId': 'OG001', 'lowerLimit': '69.9', 'upperLimit': '89.9'}, {'value': '76.3', 'groupId': 'OG002', 'lowerLimit': '67.4', 'upperLimit': '83.0'}]}]}, {'title': 'Week 16: Weight (N=39 in A, 35 in B, 164 in C)', 'categories': [{'measurements': [{'value': '77.4', 'groupId': 'OG000', 'lowerLimit': '67.9', 'upperLimit': '89.5'}, {'value': '79.9', 'groupId': 'OG001', 'lowerLimit': '70.0', 'upperLimit': '90.4'}, {'value': '76.3', 'groupId': 'OG002', 'lowerLimit': '66.3', 'upperLimit': '83.2'}]}]}, {'title': 'Week 24: Weight (N=39 in A, 36 in B, 165 in C)', 'categories': [{'measurements': [{'value': '75.5', 'groupId': 'OG000', 'lowerLimit': '66.3', 'upperLimit': '89.0'}, {'value': '79.4', 'groupId': 'OG001', 'lowerLimit': '72.5', 'upperLimit': '91.0'}, {'value': '75.8', 'groupId': 'OG002', 'lowerLimit': '65.9', 'upperLimit': '82.6'}]}]}, {'title': 'Week 32: Weight (N=37 in A, 35 in B)', 'categories': [{'measurements': [{'value': '76.5', 'groupId': 'OG000', 'lowerLimit': '69.0', 'upperLimit': '88.1'}, {'value': '80.4', 'groupId': 'OG001', 'lowerLimit': '70.8', 'upperLimit': '87.7'}, {'value': 'NA', 'comment': 'Weight was not collected at Week 32 in Arm C.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Week 36: Weight (N=162 in C)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Weight was not collected at Week 36 in Arms A and B.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Weight was not collected at Week 36 in Arms A and B.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '75.0', 'groupId': 'OG002', 'lowerLimit': '65.9', 'upperLimit': '84.0'}]}]}, {'title': 'Week 40: Weight (N=32 in A, 29 in B)', 'categories': [{'measurements': [{'value': '75.7', 'groupId': 'OG000', 'lowerLimit': '67.7', 'upperLimit': '86.4'}, {'value': '83.1', 'groupId': 'OG001', 'lowerLimit': '70.9', 'upperLimit': '91.0'}, {'value': 'NA', 'comment': 'Weight was not collected at Week 40 in Arm C.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Week 48: Weight (N=33 in A, 31 in B, 153 in C)', 'categories': [{'measurements': [{'value': '78.2', 'groupId': 'OG000', 'lowerLimit': '68.8', 'upperLimit': '88.7'}, {'value': '80.4', 'groupId': 'OG001', 'lowerLimit': '68.1', 'upperLimit': '93.3'}, {'value': '75.1', 'groupId': 'OG002', 'lowerLimit': '66.3', 'upperLimit': '84.4'}]}]}, {'title': 'Week 56: Weight (N=31 in A, 24 in B)', 'categories': [{'measurements': [{'value': '79.7', 'groupId': 'OG000', 'lowerLimit': '69.4', 'upperLimit': '92.7'}, {'value': '81.6', 'groupId': 'OG001', 'lowerLimit': '68.8', 'upperLimit': '90.9'}, {'value': 'NA', 'comment': 'Weight was not collected at Week 56 in Arm C.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Week 64: Weight (N=26 in A, 24 in B)', 'categories': [{'measurements': [{'value': '78.5', 'groupId': 'OG000', 'lowerLimit': '69.3', 'upperLimit': '87.7'}, {'value': '84.0', 'groupId': 'OG001', 'lowerLimit': '72.8', 'upperLimit': '91.9'}, {'value': 'NA', 'comment': 'Weight was not collected at Week 64 in Arm C.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Week 72: Weight (N=26 in A, 27 in B, 141 in C)', 'categories': [{'measurements': [{'value': '81.6', 'groupId': 'OG000', 'lowerLimit': '68.6', 'upperLimit': '89.6'}, {'value': '85.4', 'groupId': 'OG001', 'lowerLimit': '71.7', 'upperLimit': '94.0'}, {'value': '75.6', 'groupId': 'OG002', 'lowerLimit': '65.5', 'upperLimit': '84.6'}]}]}, {'title': 'Week 84: Weight (N=140 in C)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Weight was not collected at Week 84 in Arms A and B.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Weight was not collected at Week 84 in Arms A and B.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '77.0', 'groupId': 'OG002', 'lowerLimit': '67.6', 'upperLimit': '87.6'}]}]}, {'title': 'Week 96: Weight (N=138)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Weight was not collected at Week 96 in Arms A and B.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Weight was not collected at Week 96 in Arms A and B.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '78.4', 'groupId': 'OG002', 'lowerLimit': '69.6', 'upperLimit': '88.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Arms A and B: at entry and weeks 4, 8, 12, 16, 24, 32, 40, 48, 56, 64 and 72; Arm C: at entry and weeks 4, 8, 12, 16, 24, 36, 48, 72, 84 and 96.', 'description': 'Participant weight in kilograms.', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All Arm A, B and C participants who had weight available. The number of participants with results available at time points listed in the Time Frame are shown in the Data Table Row Titles below.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.'}, {'id': 'FG001', 'title': 'OL (PEG-IFN, RBV) Then OL Randomized (Observation)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).'}, {'id': 'FG002', 'title': 'OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)', 'description': 'At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \\<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \\& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \\>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Eligible at pre-assignment (40), direct (2), Arm C week 36 non-response (1), EVR inadvertently (1).', 'groupId': 'FG000', 'numSubjects': '44'}, {'comment': 'Eligible at pre-assignment (40), direct (1), Arm C week 36 non-response (1).', 'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '169'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '141'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '28'}]}]}], 'recruitmentDetails': 'People with hepatitis C virus (HCV)/HIV coinfection were recruited for participation in this study.', 'preAssignmentDetails': '330 participants were to receive 12 weeks of PEG+RBV to determine EVR status. Of the 330, 33 discontinued prior to week 12; 113 were non-EVRs, 80 of whom were randomized between Arms A and B; and 184 achieved EVR, 170 of whom were eligible to continue. 169 of the 170 were assigned to Arm C and one was inadvertently randomized between Arms A and B.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}, {'value': '255', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.'}, {'id': 'BG001', 'title': 'OL (PEG-IFN, RBV) Then OL Randomized (Observation)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).'}, {'id': 'BG002', 'title': 'OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)', 'description': 'At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \\<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \\& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \\>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}, {'value': '255', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.8', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '48.1', 'spread': '5.8', 'groupId': 'BG001'}, {'value': '47.2', 'spread': '7.1', 'groupId': 'BG002'}, {'value': '47.6', 'spread': '6.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}, {'value': '212', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}, {'value': '249', 'groupId': 'BG003'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All Arm A, B and C participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 333}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-04', 'studyFirstSubmitDate': '2004-02-24', 'resultsFirstSubmitDate': '2010-11-05', 'studyFirstSubmitQcDate': '2004-02-24', 'lastUpdatePostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-03-30', 'studyFirstPostDateStruct': {'date': '2004-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS)', 'timeFrame': 'Baseline and at week 72 or premature discontinuation', 'description': 'SCMFS is the difference between the Metavir fibrosis scores of the study exit and study entry liver biopsies where the difference is scaled to one year. The SCMFS assesses the annualized change in the severity of liver fibrosis on a continuous scale from -4.0 Metavir units per year (reduced fibrosis over time, a positive study outcome) to +4.0 Metavir units per year (increased fibrosis over time).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL)', 'timeFrame': 'Arms A and B: Weeks 0, 12, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 60, 72, 84', 'description': 'Qualitative plasma HCV viral load was categorized as less than 60 IU/mL vs greater than or equal to 60 IU/mL where 60 IU/mL is the lower limit of qualitative assay used in Steps 2 and 3.'}, {'measure': 'Time-scaled Change in Ishak Liver Inflammation Score (SCIIS)', 'timeFrame': 'Baseline and at week 72 or premature discontinuation', 'description': 'Liver biopsies were performed within 42 days prior to randomization between Arms A and B while the participant remained on PEG-IFN plus RBV (=entry biopsy) and again at week 72 or premature study discontinuation (=exit biopsy). SCIIS was defined as the difference between the Ishak inflammation score of the exit biopsy and the Ishak inflammation score of the entry biopsy, where the difference is scaled to one year.'}, {'measure': 'Number of Participants With Anemia', 'timeFrame': 'Up to 96 weeks', 'description': 'Number of participants with anemia by grade (defined by hemoglobin level in grams per deciliter; g/dL). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = hemoglobin of 8 to 9.4 g/dl; Grade 2 = 7 to 7.9 g/dl; Grade 3 = 6.5 to 6.9 g/dl; Grade 4 = below 6.5 g/dl.'}, {'measure': 'Number of Participants With Neutropenia', 'timeFrame': 'Up to 96 weeks', 'description': 'Number of participants with neutropenia by grade (defined by absolute neutrophil count \\[ANC\\] per cubic millimeter; mm\\^3). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = ANC of 1000 to 1500 /mm\\^3; Grade 2 = 750 to 999 /mm\\^3; Grade 3 = 500 to 749 /mm\\^3; Grade 4 = below 500 /mm\\^3.'}, {'measure': 'Number of Participants With Thrombocytopenia', 'timeFrame': 'Up to 96 weeks', 'description': 'Number of participants with thrombocytopenia by grade (defined by platelet count per cubic millimeter; mm\\^3). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = platelets of 75,000 to 99,000 /mm\\^3; Grade 2 = 50,000 to 74,999 /mm\\^3; Grade 3 = 20,000 to 49,999 /mm\\^3; Grade 4 = below 20,000 /mm\\^3.'}, {'measure': 'Number of Participants With Depression and/or Other Psychological Events', 'timeFrame': 'Up to 96 weeks', 'description': 'Depression and other psychological events. DAIDS Toxicity Grading Table (1992) was used for grading. The protocol required reporting of depression and other psychological events of Grade 3 or higher or if led to a change in treatment, regardless of grade.'}, {'measure': 'Number of Participants With High-grade Signs and Symptoms or Laboratory Values', 'timeFrame': 'Up to 96 Weeks', 'description': 'Number of participants with high-grade (Grade 3 or higher) signs and symptoms or laboratory values. DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = transient/mild discomfort, no limitation in activity, no medical intervention; Grade 2 = mild/moderate limitation in activity, some assistance, no/minimal medical intervention; Grade 3 = marked limitation in activity, some assistance, medical intervention required); Grade 4 = extreme limitation in activity, significant medical intervention, assistance, hospitalization.'}, {'measure': 'Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations', 'timeFrame': 'Up to 96 Weeks', 'description': '3-level categorical of the worst of 1) premature treatment discontinuation, 2) temporary stop or 3) dose reduction. For Arm C, the worst for either PEG-IFN or RBV is summarized.'}, {'measure': 'Number of Participants Adherent to Study Medications', 'timeFrame': 'Arm A: at weeks 12, 24, 48 and 72. Arm C: at entry and weeks 12, 24, 48, 60.', 'description': "A categorical variable with levels adherent and non-adherent based on participants' self report. For Arm A, adherence was defined as not missing PEG within 2 weeks of visit. For Arm C, adherence was defined as not missing any PEG within 2 weeks of visit and not missing RBV within 4 days of visit."}, {'measure': 'HCV Polymorphisms', 'timeFrame': 'Entry and week 72 (Arms A and B only).', 'description': 'Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued.'}, {'measure': 'HCV-specific Immune Response in Intrahepatic Lymphocytes', 'timeFrame': 'Entry and week 72 (Arms A and B only).', 'description': 'Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued.'}, {'measure': 'Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL)', 'timeFrame': 'Arms A and B: Weeks 0, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 48, 60, 72, 84', 'description': 'A blood sample was drawn to determine the HIV-1 viral load. HIV-1 viral load was categorized as \\<50 copies/mL (undetectable) or \\>=50 copies/mL (detectable). 50 is the lower limit of detection of the assay.'}, {'measure': 'Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)', 'timeFrame': 'Arms A and B: at entry and weeks 24, 48 and 72; Arm C: at entry and at weeks 12, 24, 36, 48, 72, 84 and 96.', 'description': 'Insulin resistance was evaluated by HOMA-IR, calculated as \\[fasting glucose (mg/dL) x fasting insulin (uIU/mL)\\]/405. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin and fasting glucose testing.'}, {'measure': 'Sustained Virologic Response', 'timeFrame': '24 weeks after end of treatment', 'description': 'Sustained Virologic Response (SVR) was defined as undetectable HCV viral load (\\<60 IU/ml) 24 weeks after treatment discontinuation.'}, {'measure': 'Number of Participants Who Used Antianorexia Agents, Such as Megestrol and Dronabinol', 'timeFrame': 'Up to 96 weeks', 'description': 'Use of antianorexia agents, such as megestrol and dronabinol at any time after pre-assignment.'}, {'measure': 'Number of Participants With Prescription as Needed of Erythropoietin (EPO), Granulocyte Colony-stimulating Factor (GCSF), and Granulocyte-monocyte Colony-stimulating Factor (GM-CSF)', 'timeFrame': 'At any time after pre-assignment', 'description': 'Prescription as needed of hematologic adjuvant therapies: erythropoietin (EPO), granulocyte colony-stimulating factor (GCSF), and granulocyte-monocyte colony-stimulating factor (GM-CSF) any time after pre-assignment'}, {'measure': 'Weight', 'timeFrame': 'Arms A and B: at entry and weeks 4, 8, 12, 16, 24, 32, 40, 48, 56, 64 and 72; Arm C: at entry and weeks 4, 8, 12, 16, 24, 36, 48, 72, 84 and 96.', 'description': 'Participant weight in kilograms.'}]}, 'conditionsModule': {'keywords': ['Treatment Experienced'], 'conditions': ['HIV Infections', 'Hepatitis C', 'Liver Disease']}, 'referencesModule': {'references': [{'pmid': '15731996', 'type': 'BACKGROUND', 'citation': 'Brau N. Treatment of chronic hepatitis C in human immunodeficiency virus/hepatitis C virus-coinfected patients in the era of pegylated interferon and ribavirin. Semin Liver Dis. 2005 Feb;25(1):33-51. doi: 10.1055/s-2005-864780.'}, {'pmid': '14562947', 'type': 'BACKGROUND', 'citation': 'Borgia G, Reynaud L, Gentile I, Piazza M. HIV and hepatitis C virus: facts and controversies. Infection. 2003 Aug;31(4):232-40. doi: 10.1007/s15010-003-3131-4.'}, {'pmid': '15986873', 'type': 'BACKGROUND', 'citation': 'Khalili M, Bernstein D, Lentz E, Barylski C, Hoffman-Terry M. Pegylated interferon alpha-2a with or without ribavirin in HCV/HIV coinfection: partially blinded, randomized multicenter trial. Dig Dis Sci. 2005 Jun;50(6):1148-55. doi: 10.1007/s10620-005-2723-5.'}, {'pmid': '12802757', 'type': 'BACKGROUND', 'citation': 'Neau D, Trimoulet P, Winnock M, Rullier A, Le Bail B, Lacoste D, Ragnaud JM, Bioulac-Sage P, Lafon ME, Chene G, Dupon M; ROCO Study Group. Comparison of 2 regimens that include interferon-alpha-2a plus ribavirin for treatment of chronic hepatitis C in human immunodeficiency virus-coinfected patients. Clin Infect Dis. 2003 Jun 15;36(12):1564-71. doi: 10.1086/375067. Epub 2003 Jun 3.'}, {'pmid': '14624375', 'type': 'BACKGROUND', 'citation': 'Torriani FJ, Ribeiro RM, Gilbert TL, Schrenk UM, Clauson M, Pacheco DM, Perelson AS. Hepatitis C virus (HCV) and human immunodeficiency virus (HIV) dynamics during HCV treatment in HCV/HIV coinfection. J Infect Dis. 2003 Nov 15;188(10):1498-507. doi: 10.1086/379255. Epub 2003 Nov 13.'}, {'pmid': '15282351', 'type': 'BACKGROUND', 'citation': 'Torriani FJ, Rodriguez-Torres M, Rockstroh JK, Lissen E, Gonzalez-Garcia J, Lazzarin A, Carosi G, Sasadeusz J, Katlama C, Montaner J, Sette H Jr, Passe S, De Pamphilis J, Duff F, Schrenk UM, Dieterich DT; APRICOT Study Group. Peginterferon Alfa-2a plus ribavirin for chronic hepatitis C virus infection in HIV-infected patients. N Engl J Med. 2004 Jul 29;351(5):438-50. doi: 10.1056/NEJMoa040842.'}, {'type': 'BACKGROUND', 'citation': 'The Division of AIDS Table for Grading the Severity of Adult Adverse Events (DAIDS AE Grading Table), August 1992.'}, {'type': 'BACKGROUND', 'citation': 'Manual for Expedited Reporting of Adverse Events to Division of AIDS (DAIDS EAE Manual), May 2004.'}, {'pmid': '21535051', 'type': 'RESULT', 'citation': 'Butt AA, Umbleja T, Andersen JW, Chung RT, Sherman KE; ACTG A5178 Study Team. The incidence, predictors and management of anaemia and its association with virological response in HCV / HIV coinfected persons treated with long-term pegylated interferon alfa 2a and ribavirin. Aliment Pharmacol Ther. 2011 Jun;33(11):1234-44. doi: 10.1111/j.1365-2036.2011.04648.x. Epub 2011 Mar 29.'}, {'pmid': '20921898', 'type': 'RESULT', 'citation': 'Sherman KE, Andersen JW, Butt AA, Umbleja T, Alston B, Koziel MJ, Peters MG, Sulkowski M, Goodman ZD, Chung RT; AIDS Clinical Trials Group A5178 Study Team. Sustained long-term antiviral maintenance therapy in HCV/HIV-coinfected patients (SLAM-C). J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):597-605. doi: 10.1097/QAI.0b013e3181f6d916.'}, {'pmid': '22510354', 'type': 'RESULT', 'citation': 'Chung RT, Umbleja T, Chen JY, Andersen JW, Butt AA, Sherman KE; Actg A5178 Study Team. Extended therapy with pegylated interferon and weight-based ribavirin for HCV-HIV coinfected patients. HIV Clin Trials. 2012 Mar-Apr;13(2):70-82. doi: 10.1310/hct1302-70.'}, {'pmid': '22563020', 'type': 'RESULT', 'citation': 'Butt AA, Umbleja T, Andersen JW, Sherman KE, Chung RT; ACTG A5178 Study Team. Impact of peginterferon alpha and ribavirin treatment on lipid profiles and insulin resistance in Hepatitis C virus/HIV-coinfected persons: the AIDS Clinical Trials Group A5178 Study. Clin Infect Dis. 2012 Sep;55(5):631-8. doi: 10.1093/cid/cis463. Epub 2012 May 4.'}, {'pmid': '23739141', 'type': 'DERIVED', 'citation': 'Branch AD, Kang M, Hollabaugh K, Wyatt CM, Chung RT, Glesby MJ. In HIV/hepatitis C virus co-infected patients, higher 25-hydroxyvitamin D concentrations were not related to hepatitis C virus treatment responses but were associated with ritonavir use. Am J Clin Nutr. 2013 Aug;98(2):423-9. doi: 10.3945/ajcn.112.048785. Epub 2013 Jun 5.'}, {'pmid': '19268724', 'type': 'DERIVED', 'citation': 'Shire NJ, Rao MB, Succop P, Buncher CR, Andersen JA, Butt AA, Chung RT, Sherman KE; AIDS Clinical Trials Group 5178 Study Group. Improving noninvasive methods of assessing liver fibrosis in patients with hepatitis C virus/human immunodeficiency virus co-infection. Clin Gastroenterol Hepatol. 2009 Apr;7(4):471-80, 480.e1-2. doi: 10.1016/j.cgh.2008.12.016. Epub 2008 Dec 25.'}]}, 'descriptionModule': {'briefSummary': 'Infection with both HIV and hepatitis C virus (HCV) may result in serious and sometimes fatal liver disease. The purpose of this study was to test the effectiveness of long-term pegylated interferon alfa-2a (PEG-IFN) and ribavirin treatment in slowing liver disease progression in people infected with both HIV and HCV.', 'detailedDescription': 'Rapid progression of liver disease to liver failure has been observed in people coinfected with HIV and HCV. This observation appears to be directly related to an increase in the rate of fibrotic progression in the liver compared to people infected with HCV alone. PEG-IFN and ribavirin are used in standard treatment of HCV. This study tested the effectiveness of using PEG-IFN in reducing the rate of liver fibrosis progression in participants coinfected with HIV and HCV who could not lower their HCV viral load to undetectable or who could not maintain their HCV viral load at undetectable on PEG-IFN and ribavirin treatment.\n\nParticipants entered Step 1 (initial run-in period) to receive 12 weeks of 180 mcg PEG-IFN subcutaneously once weekly plus 1 to 1.2 g/day ribavirin based on body weight. At week 12, HCV RNA testing was performed.\n\nParticipants with early virologic response (EVR), defined as \\>=2 log10 drop in HCV RNA from baseline or undetectable HCV RNA (\\<600 IU/ml with quantitative assay used in Step 1) at Week 12, who had tolerated Step 1 treatment, entered into Step 3 to continue receiving the Step 1 treatment for a total of 72 weeks (Arm C). Participants who did not meet the criteria for entry into Step 3 were discontinued from the study. In Step 3, participants were followed for an additional 24 weeks after treatment discontinuation to determine sustained virologic response (SVR). Initially, Step 3 participants who had a detectable HCV viral load (\\>=60 IU/ml with the qualitative assay used in Step 3) at Week 36 were eligible to enroll in Step 2. After early closure of Step 2, such participants remained in Step 3 until study completion.\n\nParticipants with \\<2 log10 drop in HCV RNA from baseline and detectable HCV RNA at Week 12 (non-EVR) discontinued Step 1 treatment. Non-EVRs who met the Step 2 eligibility criteria, were enrolled in Step 2 and randomized to receive 180 mcg PEG-IFN subcutaneously weekly for 72 weeks (Arm A) or observation for 72 weeks (Arm B). Participants who did not meet the criteria for entry into Step 2 were discontinued from the study. Step 2 of the study was closed prematurely in May 2007 due to lower than expected progression rates among the participants in the observation arm such that the primary objective could not be reached. There were no safety concerns.\n\nLiver biopsies were conducted at study screening, and at Step 2 entry and exit until the early closure of Step 2. Medical history assessment, physical exams, and blood collection were conducted every 4-12 weeks for participants in Steps 1, 2, and 3. Participants were followed for up to 18 weeks in Step 1, followed by a total of 72 in Step 2 or by up to a total of 84 weeks in Step 3.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria for Step 1:\n\n* HIV infected\n* Stable antiretroviral therapy for at least 8 weeks prior to study entry OR have not received any antiretroviral therapy for at least 4 weeks prior to entry\n* HIV viral load less than 50,000 copies/ml within 6 weeks prior to study entry\n* CD4 count greater than 200 cells/mm\\^3 within 6 weeks prior to study entry\n* Hepatitis C virus (HCV) infected\n* Either HCV treatment naive OR previously treated with interferon (IFN), PEG-IFN, IFN and ribavirin, or PEG-IFN and ribavirin for at least 12 weeks and HCV RNA positive following their last course of HCV treatment\n* Chronic liver disease consistent with chronic viral hepatitis\n* At least stage I fibrosis on a liver biopsy obtained within 104 weeks of study entry\n* If at stage VI fibrosis, Child-Pugh-Turcotte (CPT) score of 5 or less and no more than Child-Pugh Class A\n* Liver enzyme (alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], and alkaline phosphatase) levels 10 times or less than upper limit of normal\n* Agree to use acceptable methods of contraception\n\nInclusion Criteria for Step 2:\n\n* Currently enrolled in Step 1 or received 12 weeks of PEG-IFN plus ribavirin outside this study\n* Detectable HCV viral load and \\<2 log10 decrease from baseline in plasma/serum HCV viral load at Week 12.\n* On Step 1 study treatment for no longer than 18 weeks\n\nInclusion Criteria for Step 3:\n\n* Currently enrolled in Step 1\n* Undetectable HCV RNA or a 2-log or greater decrease in plasma/serum HCV viral load.\n* On Step 1 study treatment for no longer than 18 weeks\n\nExclusion Criteria for Steps 1 and 3:\n\n* Have received HCV treatment within 4 weeks of study entry. Participants currently receiving treatment for HCV, if non-EVRs, were considered for direct entry into Step 2, without the run-in period in Step 1.\n* Could not tolerate treatment with PEG-IFN, defined as missing 3 or more consecutive PEG-IFN doses during the first 12 weeks or a total of 5 doses prior to Step 3 entry. Participants who have missed doses of ribavirin will not be excluded from Step 3 entry.\n* Use of granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days prior to study entry\n* Alpha feto protein level 400 ng/ml or greater within 24 weeks prior to study entry, or alpha feto protein level greater than 50 ng/ml and less than 400 ng/ml (unless computed tomography \\[CT\\] scan or magnetic resonance imaging \\[MRI\\] shows no evidence of hepatic tumor) within 24 weeks prior to study entry\n* Decompensated liver disease, including presence or history of ascites, variceal bleeding, and brain or nervous system damage as a result of liver damage\n* Other causes of significant liver disease, including hepatitis A or B, excess iron deposits in the liver (hemochromatosis), or homozygote alpha-1 antitrypsin deficiency\n* Use of systemic corticosteroids, interferon gamma, TNF-alpha inhibitors, rifampin, rifabutin, pyrazinamide, isoniazid, ganciclovir, or hydroxyurea within 2 weeks prior to study entry\n* Known allergy/sensitivity to PEG-IFN alfa-2a or ribavirin or their formulations\n* History of uncontrolled seizure disorders\n* Clinically active thyroid disease. Thyroid hormone replacement therapy is permitted, but thyroid-stimulating hormone (TSH) and free thyroxine index (FTI) must be in normal range.\n* History of autoimmune processes, including Crohn's disease, ulcerative colitis, severe psoriasis, and rheumatoid arthritis, that may be made worse by interferon use\n* Any systemic antineoplastic or immunomodulatory treatment or radiation within 24 weeks prior to study entry\n* Malignancy\n* Active coronary artery disease within 24 weeks prior to study entry\n* Acute or active AIDS-defining opportunistic infections within 12 weeks of study entry\n* Hemoglobin abnormalities (e.g., thalassemia) or any other cause of or tendency to break down red blood cells (hemolysis)\n* History of major organ transplantation with an existing functional graft\n* Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with study adherence\n* Uncontrolled or active depression or other psychiatric disorder, such as untreated Grade 3 psychiatric disorder, medically untreatable Grade 3 disorder, or any hospitalization within 52 weeks of study entry that, in the opinion of the investigator, may interfere with study requirements\n* Other serious illness or chronic medical condition that, in the opinion of the investigator, may have prevented participant's completion of the study\n* Pregnant or breastfeeding"}, 'identificationModule': {'nctId': 'NCT00078403', 'briefTitle': 'Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV)', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Suppressive Long-Term Antiviral Management of Hepatitis C Virus (HCV) and HIV-1 Coinfected Subjects (SLAM-C)', 'orgStudyIdInfo': {'id': 'A5178'}, 'secondaryIdInfos': [{'id': '10008', 'type': 'REGISTRY', 'domain': 'DAIDS ES Registry Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.', 'interventionNames': ['Drug: Peginterferon alfa-2a', 'Drug: Ribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: OL (PEG-IFN, RBV) then OL Randomized (Observation)', 'description': 'At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \\>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).', 'interventionNames': ['Drug: Peginterferon alfa-2a', 'Drug: Ribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C: OL (PEG-IFN, RBV) then OL (PEG-IFN, RBV)', 'description': 'At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \\<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \\& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \\>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.', 'interventionNames': ['Drug: Peginterferon alfa-2a', 'Drug: Ribavirin']}], 'interventions': [{'name': 'Peginterferon alfa-2a', 'type': 'DRUG', 'description': '180 mcg PEG-IFN subcutaneously', 'armGroupLabels': ['Arm A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'Arm B: OL (PEG-IFN, RBV) then OL Randomized (Observation)', 'Arm C: OL (PEG-IFN, RBV) then OL (PEG-IFN, RBV)']}, {'name': 'Ribavirin', 'type': 'DRUG', 'description': 'One tablet or capsule containing ribavirin 200 mg', 'armGroupLabels': ['Arm A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)', 'Arm B: OL (PEG-IFN, RBV) then OL Randomized (Observation)', 'Arm C: OL (PEG-IFN, RBV) then OL (PEG-IFN, RBV)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35924-2050', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Therapeutics CRS', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90033-1079', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California CRS', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90035', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA CARE Center CRS', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304-5350', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford AIDS Clinical Trials Unit CRS', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Antiviral Research Center CRS', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Ucsf Hiv/Aids Crs', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '95128', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Santa Clara Valley Med. Ctr.', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital CRS', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University CRS (GU CRS)', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '96816', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Univ. of Hawaii at Manoa, Leahi Hosp.', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University CRS', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202-5250', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Univ. School of Medicine, Infectious Disease Research Clinic', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46202-5250', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Univ. School of Medicine, Wishard Memorial', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University CRS', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital CRS (MGH CRS)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hosp. ACTG CRS", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Med. Ctr., ACTG CRS', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110-1010', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University Therapeutics (WT) CRS', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68198-9500', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Beth Israel Med. Ctr., ACTU', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Chelsea CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NY Univ. HIV/AIDS CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Uptown CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032-3732', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia P&S CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14607', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Trillium Health ACTG CRS', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Univ. of Rochester ACTG 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': '45267-0405', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati CRS', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth CRS', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.', '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': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'The Miriam Hospital Clinical Research Site (TMH CRS) CRS', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '37204', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Therapeutics (VT) CRS', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75235-9173', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77555-0435', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ. of Texas Medical Branch, ACTU', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '00935', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Puerto Rico AIDS Clinical Trials Unit CRS', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Kenneth E. Sherman, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Cincinnati'}, {'name': 'Raymond Chung, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Harvard/Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}