Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
Study NCT ID:
NCT01734850
Status:
COMPLETED
Last Update Posted:
2020-08-06
First Post:
2012-11-19
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1 Infection
Sponsor:
Organization:
Raw JSON
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Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002066', 'term': 'Busulfan'}], 'ancestors': [{'id': 'D002072', 'term': 'Butylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008698', 'term': 'Mesylates'}, {'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@cslbehring.com', 'phone': '484-878-4000', 'title': 'Trial Registration Coordinator', 'organization': 'CSL Behring'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 48 weeks per participant', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1 (CSL202 With No Busulfan)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 2 (CSL202 With 1 Busulfan Dose)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 3 (CSL202 With 2 Busulfan Doses)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose 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'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 18, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 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5, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malaise', 'stats': [{'groupId': 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash vesicular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 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'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Faeces soft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tongue discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Secondary syphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tinea pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CD4 lymphocytes decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnambulism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paranasal sinus hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tonsillar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper-airway cough syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eosinophilic pustular folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seborrhoeic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Severe and Life-threatening Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (CSL202 With No Busulfan)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning'}, {'id': 'OG001', 'title': 'Cohort 2 (CSL202 With 1 Busulfan Dose)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}, {'id': 'OG002', 'title': 'Cohort 3 (CSL202 With 2 Busulfan Doses)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}], 'classes': [{'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Life-threatening', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 48 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population (SP): The safety population includes all enrolled subjects signing informed consent who started the interventional phase of the trial (i.e. CD4+ Apheresis and discontinued subjects who re-commenced ART)'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Severe or Life-threatening AEs Related to CSL202', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (CSL202 With No Busulfan)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning'}, {'id': 'OG001', 'title': 'Cohort 2 (CSL202 With 1 Busulfan Dose)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}, {'id': 'OG002', 'title': 'Cohort 3 (CSL202 With 2 Busulfan Doses)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC)administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 48 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SP'}, {'type': 'PRIMARY', 'title': 'Number of Participants With the Presence of Replication-competent Retrovirus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (CSL202 With No Busulfan)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning'}, {'id': 'OG001', 'title': 'Cohort 2 (CSL202 With 1 Busulfan Dose)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}, {'id': 'OG002', 'title': 'Cohort 3 (CSL202 With 2 Busulfan Doses)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC)administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 48 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SP'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Predominant Integration Site Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (CSL202 With No Busulfan)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning'}, {'id': 'OG001', 'title': 'Cohort 2 (CSL202 With 1 Busulfan Dose)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}, {'id': 'OG002', 'title': 'Cohort 3 (CSL202 With 2 Busulfan Doses)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC)administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not done because Cal-1 Marking was \\<1% at the corresponding time point required', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not done because Cal-1 Marking was \\<1% at the corresponding time point required', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Not done because Cal-1 Marking was \\<1% at the corresponding time point required', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 48 weeks', 'description': 'Vector Integration Site Analysis performed only when Cal-1 Marking is \\>= 1%.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)'}, {'type': 'PRIMARY', 'title': 'Mean Cell Dose for CD4+ Cells (Ttn)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (CSL202 With No Busulfan)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning'}, {'id': 'OG001', 'title': 'Cohort 2 (CSL202 With 1 Busulfan Dose)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}, {'id': 'OG002', 'title': 'Cohort 3 (CSL202 With 2 Busulfan Doses)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC)administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}], 'classes': [{'categories': [{'measurements': [{'value': '16.940', 'groupId': 'OG000', 'lowerLimit': '14.61', 'upperLimit': '20.62'}, {'value': '81.855', 'groupId': 'OG001', 'lowerLimit': '38.94', 'upperLimit': '138.68'}, {'value': '49.553', 'groupId': 'OG002', 'lowerLimit': '20.70', 'upperLimit': '79.29'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 weeks', 'unitOfMeasure': 'Number (10^8 cells)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)'}, {'type': 'PRIMARY', 'title': 'Mean Cell Dose for CD34+ Cells (HSPCtn)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (CSL202 With No Busulfan)', 'description': 'Cal-1 modified HSPC and Cal-1 modified 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'timeFrame': 'Up to 48 weeks', 'unitOfMeasure': 'Number (10^6 cells/kg body weight)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)'}, {'type': 'PRIMARY', 'title': 'Percent Transduction Efficiency of CD4+ Cells (Ttn) and CD34+ Cells (HSPCtn) of Final Cell Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (CSL202 With No Busulfan)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning'}, {'id': 'OG001', 'title': 'Cohort 2 (CSL202 With 1 Busulfan Dose)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}, {'id': 'OG002', 'title': 'Cohort 3 (CSL202 With 2 Busulfan Doses)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC)administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}], 'classes': [{'title': 'CD4+ Cells (Ttn)', 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000', 'lowerLimit': '21.0', 'upperLimit': '60.0'}, {'value': '29.2', 'groupId': 'OG001', 'lowerLimit': '13.0', 'upperLimit': '39.0'}, {'value': '66.8', 'groupId': 'OG002', 'lowerLimit': '39.0', 'upperLimit': '84.0'}]}]}, {'title': 'CD34+ Cells (HSPCtn)', 'categories': [{'measurements': [{'value': '58.6', 'groupId': 'OG000', 'lowerLimit': '51.0', 'upperLimit': '77.0'}, {'value': '26.3', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '53.0'}, {'value': '31.3', 'groupId': 'OG002', 'lowerLimit': '21.0', 'upperLimit': '49.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 weeks', 'unitOfMeasure': 'Percent transduction efficiency', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)'}, {'type': 'PRIMARY', 'title': 'Total Area Under the Curve (AUC) for Busulfan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2 (CSL202 With 1 Busulfan Dose)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}, {'id': 'OG001', 'title': 'Cohort 3 (CSL202 With 2 Busulfan Doses)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}], 'classes': [{'categories': [{'measurements': [{'value': '6521.5', 'groupId': 'OG000', 'lowerLimit': '5863', 'upperLimit': '7259'}, {'value': '8296.8', 'groupId': 'OG001', 'lowerLimit': '7893', 'upperLimit': '8601'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 weeks', 'description': 'Cohort 3: Total AUC = first dose AUC value + second dose AUC value', 'unitOfMeasure': 'micromolar*min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)'}, {'type': 'SECONDARY', 'title': 'Percent Cal-1 Marking in Peripheral Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (CSL202 With No Busulfan)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning'}, {'id': 'OG001', 'title': 'Cohort 2 (CSL202 With 1 Busulfan Dose)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}, {'id': 'OG002', 'title': 'Cohort 3 (CSL202 With 2 Busulfan Doses)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC)administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}], 'classes': [{'title': 'Peak marking', 'categories': [{'measurements': [{'value': '0.3500', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '1.1600'}, {'value': '0.7650', 'groupId': 'OG001', 'lowerLimit': '0.6100', 'upperLimit': '0.8900'}, {'value': '3.1200', 'groupId': 'OG002', 'lowerLimit': '0.1800', 'upperLimit': '7.4600'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.0000'}, {'value': '0.1275', 'groupId': 'OG001', 'lowerLimit': '0.0000', 'upperLimit': '0.3800'}, {'value': '0.1275', 'groupId': 'OG002', 'lowerLimit': '0.0000', 'upperLimit': '0.4900'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 weeks', 'unitOfMeasure': 'percent Cal-1 marking', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)'}, {'type': 'SECONDARY', 'title': 'Cal-1 Marking in Gut-associated Lymphoid Tissue (GALT) (10-15 cm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (CSL202 With No Busulfan)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning'}, {'id': 'OG001', 'title': 'Cohort 2 (CSL202 With 1 Busulfan Dose)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}, {'id': 'OG002', 'title': 'Cohort 3 (CSL202 With 2 Busulfan Doses)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC)administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}], 'classes': [{'title': 'Peak marking', 'categories': [{'measurements': [{'value': '0.8121', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.7054'}, {'value': '0.0007', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0019'}, {'value': '0.0022', 'groupId': 'OG002', 'lowerLimit': '0.0006', 'upperLimit': '0.0060'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '0.8121', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.7054'}, {'value': '0.0004', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0010'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.0004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 weeks', 'description': 'Samples were collected via endoscopic biopsy from the sigmoid colon: 10-15 cm from the anal margin', 'unitOfMeasure': 'copies/cell', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)'}, {'type': 'SECONDARY', 'title': 'Cal-1 Marking in GALT (25-35 cm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (CSL202 With No Busulfan)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning'}, {'id': 'OG001', 'title': 'Cohort 2 (CSL202 With 1 Busulfan Dose)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}, {'id': 'OG002', 'title': 'Cohort 3 (CSL202 With 2 Busulfan Doses)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC)administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}], 'classes': [{'title': 'Peak marking', 'categories': [{'measurements': [{'value': '0.0255', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0677'}, {'value': '0.0003', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0011'}, {'value': '0.0068', 'groupId': 'OG002', 'lowerLimit': '0.0020', 'upperLimit': '0.0186'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '0.0255', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0677'}, {'value': '0.0003', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0011'}, {'value': '0.0055', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.0186'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 weeks', 'description': 'Samples were collected via endoscopic biopsy from the sigmoid colon: 25-35 cm from the anal margin', 'unitOfMeasure': 'copies/cell', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)'}, {'type': 'SECONDARY', 'title': 'Cal-1 Marking in Bone Marrow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (CSL202 With No Busulfan)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning'}, {'id': 'OG001', 'title': 'Cohort 2 (CSL202 With 1 Busulfan Dose)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}, {'id': 'OG002', 'title': 'Cohort 3 (CSL202 With 2 Busulfan Doses)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC)administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}], 'classes': [{'title': 'Peak marking', 'categories': [{'measurements': [{'value': '0.0007', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0026'}, {'value': '0.0539', 'groupId': 'OG001', 'lowerLimit': '0.0005', 'upperLimit': '0.2027'}, {'value': '0.0021', 'groupId': 'OG002', 'lowerLimit': '0.0009', 'upperLimit': '0.0030'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '0.0007', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0026'}, {'value': '0.0015', 'groupId': 'OG001', 'lowerLimit': '0.0005', 'upperLimit': '0.0044'}, {'value': '0.0009', 'groupId': 'OG002', 'lowerLimit': '0.0003', 'upperLimit': '0.0025'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 weeks', 'unitOfMeasure': 'copies/cell', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)'}, {'type': 'SECONDARY', 'title': 'Cal-1 C46 Expression in Peripheral Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (CSL202 With No Busulfan)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning'}, {'id': 'OG001', 'title': 'Cohort 2 (CSL202 With 1 Busulfan Dose)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}, {'id': 'OG002', 'title': 'Cohort 3 (CSL202 With 2 Busulfan Doses)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC)administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}], 'classes': [{'title': 'Peak marking', 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.0000'}, {'value': '1.0496', 'groupId': 'OG001', 'lowerLimit': '0.0000', 'upperLimit': '2.9977'}, {'value': '2.1701', 'groupId': 'OG002', 'lowerLimit': '0.0000', 'upperLimit': '6.4800'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.0000'}, {'value': '0.0000', 'groupId': 'OG001', 'lowerLimit': '0.0000', 'upperLimit': '0.0000'}, {'value': '0.0000', 'groupId': 'OG002', 'lowerLimit': '0.0000', 'upperLimit': '0.0000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 weeks', 'description': 'C46 relative expression will be analyzed by reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) and normalized to the expression of β2-microglobulin (β2M) mRNA', 'unitOfMeasure': 'units of relative expression', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)'}, {'type': 'SECONDARY', 'title': 'Cal-1 sh5 Expression in Peripheral Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (CSL202 With No Busulfan)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning'}, {'id': 'OG001', 'title': 'Cohort 2 (CSL202 With 1 Busulfan Dose)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}, {'id': 'OG002', 'title': 'Cohort 3 (CSL202 With 2 Busulfan Doses)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC)administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}], 'classes': [{'title': 'Peak marking', 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.0000'}, {'value': '0.2027', 'groupId': 'OG001', 'lowerLimit': '0.0000', 'upperLimit': '0.6489'}, {'value': '1.6933', 'groupId': 'OG002', 'lowerLimit': '0.1930', 'upperLimit': '4.6736'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.0000'}, {'value': '0.0000', 'groupId': 'OG001', 'lowerLimit': '0.0000', 'upperLimit': '0.0000'}, {'value': '0.0000', 'groupId': 'OG002', 'lowerLimit': '0.0000', 'upperLimit': '0.0000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 weeks', 'description': 'sh5 relative expression will be analyzed by RT-qPCR and normalized to the expression of RNU38B microRNA', 'unitOfMeasure': 'units of relative expression', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)'}, {'type': 'SECONDARY', 'title': 'HIV Viral Load at Baseline Screening and Week 48 or at Anti-retroviral Therapy (ART) Re-commencement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (CSL202 With No Busulfan)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning'}, {'id': 'OG001', 'title': 'Cohort 2 (CSL202 With 1 Busulfan Dose)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}, {'id': 'OG002', 'title': 'Cohort 3 (CSL202 With 2 Busulfan Doses)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC)administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}], 'classes': [{'title': 'Baseline screening', 'categories': [{'measurements': [{'value': '4.59', 'groupId': 'OG000', 'lowerLimit': '4.06', 'upperLimit': '4.87'}, {'value': '4.51', 'groupId': 'OG001', 'lowerLimit': '3.98', 'upperLimit': '4.82'}, {'value': '4.28', 'groupId': 'OG002', 'lowerLimit': '3.45', 'upperLimit': '4.62'}]}]}, {'title': 'Week 48 or at ART re-commencement', 'categories': [{'measurements': [{'value': '4.56', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '4.93'}, {'value': '4.70', 'groupId': 'OG001', 'lowerLimit': '3.88', 'upperLimit': '4.96'}, {'value': '4.61', 'groupId': 'OG002', 'lowerLimit': '4.20', 'upperLimit': '4.95'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 weeks', 'unitOfMeasure': 'Log10 (copies/mL)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)'}, {'type': 'SECONDARY', 'title': 'CD4+ Count at Baseline Screening and Week 48 or at ART Re-commencement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (CSL202 With No Busulfan)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning'}, {'id': 'OG001', 'title': 'Cohort 2 (CSL202 With 1 Busulfan Dose)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}, {'id': 'OG002', 'title': 'Cohort 3 (CSL202 With 2 Busulfan Doses)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC)administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}], 'classes': [{'title': 'Baseline screening', 'categories': [{'measurements': [{'value': '680.75', 'groupId': 'OG000', 'lowerLimit': '522.5', 'upperLimit': '809.5'}, {'value': '575.13', 'groupId': 'OG001', 'lowerLimit': '537.0', 'upperLimit': '677.5'}, {'value': '668.63', 'groupId': 'OG002', 'lowerLimit': '529.0', 'upperLimit': '878.0'}]}]}, {'title': 'Week 48 or at ART re-commencement', 'categories': [{'measurements': [{'value': '553.3', 'groupId': 'OG000', 'lowerLimit': '450', 'upperLimit': '759'}, {'value': '383.5', 'groupId': 'OG001', 'lowerLimit': '274', 'upperLimit': '549'}, {'value': '245.5', 'groupId': 'OG002', 'lowerLimit': '152', 'upperLimit': '385'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 weeks', 'unitOfMeasure': 'CD4+ cells/cubic mm', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HIV-1 Tropism Shift', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (CSL202 With No Busulfan)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning'}, {'id': 'OG001', 'title': 'Cohort 2 (CSL202 With 1 Busulfan Dose)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}, {'id': 'OG002', 'title': 'Cohort 3 (CSL202 With 2 Busulfan Doses)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC)administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 48 weeks', 'description': 'Shift from R5 to X4 or dual/mixed tropism', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SP'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1 (CSL202 With No Busulfan)', 'description': 'Cal-1 modified Hematopoietic stem/progenitor cells (HSPC) and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning'}, {'id': 'FG001', 'title': 'Cohort 2 (CSL202 With 1 Busulfan Dose)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}, {'id': 'FG002', 'title': 'Cohort 3 (CSL202 With 2 Busulfan Doses)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Continued to Week 48 but recommenced ART', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Not infused due to manufacturing failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1 (CSL202 With No Busulfan)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning'}, {'id': 'BG001', 'title': 'Cohort 2 (CSL202 With 1 Busulfan Dose)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}, {'id': 'BG002', 'title': 'Cohort 3 (CSL202 With 2 Busulfan Doses)', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC)administered as pre-conditioning for transplant\n\nBusulfan: Intravenous busulfan'}, {'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': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', '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': '43.0', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '48.5', 'spread': '12.8', 'groupId': 'BG001'}, {'value': '46.8', 'spread': '3.1', 'groupId': 'BG002'}, {'value': '46.2', 'spread': '9.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-07-08', 'size': 1757320, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-06-24T15:39', 'hasProtocol': True}, {'date': '2017-12-15', 'size': 29666705, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-06-24T15:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'dispFirstSubmitDate': '2018-09-17', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-22', 'studyFirstSubmitDate': '2012-11-19', 'dispFirstSubmitQcDate': '2018-09-17', 'resultsFirstSubmitDate': '2020-06-25', 'studyFirstSubmitQcDate': '2012-11-22', 'dispFirstPostDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-22', 'studyFirstPostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Severe and Life-threatening Adverse Events (AEs)', 'timeFrame': 'Up to 48 weeks'}, {'measure': 'Number of Participants With Severe or Life-threatening AEs Related to CSL202', 'timeFrame': 'Up to 48 weeks'}, {'measure': 'Number of Participants With the Presence of Replication-competent Retrovirus', 'timeFrame': 'Up to 48 weeks'}, {'measure': 'Number of Participants With Predominant Integration Site Analysis', 'timeFrame': 'Up to 48 weeks', 'description': 'Vector Integration Site Analysis performed only when Cal-1 Marking is \\>= 1%.'}, {'measure': 'Mean Cell Dose for CD4+ Cells (Ttn)', 'timeFrame': 'Up to 48 weeks'}, {'measure': 'Mean Cell Dose for CD34+ Cells (HSPCtn)', 'timeFrame': 'Up to 48 weeks'}, {'measure': 'Percent Transduction Efficiency of CD4+ Cells (Ttn) and CD34+ Cells (HSPCtn) of Final Cell Product', 'timeFrame': 'Up to 48 weeks'}, {'measure': 'Total Area Under the Curve (AUC) for Busulfan', 'timeFrame': 'Up to 48 weeks', 'description': 'Cohort 3: Total AUC = first dose AUC value + second dose AUC value'}], 'secondaryOutcomes': [{'measure': 'Percent Cal-1 Marking in Peripheral Blood', 'timeFrame': 'Up to 48 weeks'}, {'measure': 'Cal-1 Marking in Gut-associated Lymphoid Tissue (GALT) (10-15 cm)', 'timeFrame': 'Up to 48 weeks', 'description': 'Samples were collected via endoscopic biopsy from the sigmoid colon: 10-15 cm from the anal margin'}, {'measure': 'Cal-1 Marking in GALT (25-35 cm)', 'timeFrame': 'Up to 48 weeks', 'description': 'Samples were collected via endoscopic biopsy from the sigmoid colon: 25-35 cm from the anal margin'}, {'measure': 'Cal-1 Marking in Bone Marrow', 'timeFrame': 'Up to 48 weeks'}, {'measure': 'Cal-1 C46 Expression in Peripheral Blood', 'timeFrame': 'Up to 48 weeks', 'description': 'C46 relative expression will be analyzed by reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) and normalized to the expression of β2-microglobulin (β2M) mRNA'}, {'measure': 'Cal-1 sh5 Expression in Peripheral Blood', 'timeFrame': 'Up to 48 weeks', 'description': 'sh5 relative expression will be analyzed by RT-qPCR and normalized to the expression of RNU38B microRNA'}, {'measure': 'HIV Viral Load at Baseline Screening and Week 48 or at Anti-retroviral Therapy (ART) Re-commencement', 'timeFrame': 'Up to 48 weeks'}, {'measure': 'CD4+ Count at Baseline Screening and Week 48 or at ART Re-commencement', 'timeFrame': 'Up to 48 weeks'}, {'measure': 'Number of Participants With HIV-1 Tropism Shift', 'timeFrame': 'Up to 48 weeks', 'description': 'Shift from R5 to X4 or dual/mixed tropism'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV-1'], 'conditions': ['Human Immunodeficiency Virus']}, 'descriptionModule': {'briefSummary': 'This is an early phase research study looking at whether an experimental gene transfer, LVsh5/C46 (also known as Cal-1), is safe and if it can protect the immune system from the effects of HIV without the use of antiretroviral drugs.\n\nCal-1 is an experimental gene transfer agent designed to inhibit HIV infection through 2 active parts:\n\n1. Removing a protein named CCR5 from bone marrow and white blood cells\n2. Producing a protein named C46 on bone marrow and white blood cells', 'detailedDescription': 'It is estimated that 33 million individuals are currently infected with HIV. HIV/AIDS is a disease that impairs immune function, primarily by decreasing CD4+ T lymphocytes. The progression can be contained by daily dosing with antiretroviral therapy (ART) but there are side effects that can be treatment limiting, and the development of HIV drug resistance can force the physician to modify the ART regimen. There are no effective vaccines currently available for HIV.\n\nLVsh5/C46 (also known as Cal-1) is a dual therapeutic, self-inactivating lentiviral vector that encodes for both a short hairpin RNA against the HIV-1 co-receptor CCR5 (sh5) and a HIV-1 fusion inhibitor, C46 and inhibits two processes required for HIV-1 infection:\n\n1. Binding of the virus to the cellular CCR5 co-receptor and\n2. Fusion of the virus with the host cell\n\nThe rationale is that Cal-1 introduced into hematopoietic progenitor/stem cells (HSPC) and mature CD4+ T lymphocytes will protect these cells and their progeny cells from HIV-1 infection and its pathogenic sequelae. This may provide a continuous means of controlling HIV-1 after a single or infrequent dose(s), thereby decreasing or delaying (partially or completely) the need for antiretroviral drug therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Prior to any study-related procedures, signed informed consent indicating that they understand the purpose, risks and procedures required for the study and are willing to participate in the study\n* Individuals aged 18 to 65 years of age (inclusive) at time of consent\n* Documented HIV-1 infection ≥ 6 months prior to Screening 1\n* Previous treatment with antiretroviral agents that had a demonstrated suppressive effect (defined as plasma HIV RNA ≤ 50 copies/ml)\n* A documented viable ART regimen option, as determined by the Investigator, taking into account prior ART experience and HIV geno/phenotyping analyses\n* Not taking antiretroviral therapy for ≥ 6 weeks prior to Screening 1, for one or more of the following reasons:\n\n i) Concerns over short-term or long-term toxicities associated with antiretroviral agents, or ii) Treatment fatigue from the daily regimen of life-long therapy\n* Plasma HIV-1 viral RNA ≥ 5,000 copies/mL and ≤ 100,000 copies/ml at Screening 1 and Screening 2\n* CD4+ T lymphocyte count ≥ 500 cells/µl at Screening 1 and Screening 2\n\nExclusion Criteria:\n\n* Abnormal hematology at Screening 1: Absolute neutrophil count (ANC) \\< 1.5 x 109/L, Platelet count \\< 100 x 109/L, Hemoglobin \\< 10 g/dL\n* Abnormal biochemistry at Screening 1: Alanine aminotransferase (ALT) \\> 2.5 x Upper Limit of Normal (ULN), Total bilirubin \\> 1.5 x ULN, Serum creatinine \\> 1.5 x ULN\n* Detection of any CXCR4-tropic HIV-1 at Screening 1\n* Evidence of co-infection with hepatitis B virus, hepatitis C virus, West Nile Virus, or HTLV-1 as detected at Screening 2\n* Evidence of active TB infection determined by positive QuantiFERON®-TB Gold/IGRA test result and clinical confirmation at Screening 2\n* ART or other antiretroviral therapy within 6 weeks of Screening 1 or any time during the pre-infusion period\n* Documented history of CD4+ T lymphocyte count \\< 250 cells/µl\n* Any previous or current AIDS-defining illnesses (CDC Category C), including AIDS-related dementia, with the exception of Kaposi's sarcoma confined to the skin\n* History of malignancy or systemic chemotherapy within the last 5 years (i.e., subjects with prior malignancy must be disease-free for 5 years), except curatively-treated basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical or anal intra-epithelial neoplasia\n* History of steroid-dependent asthma in the past 5 years\n* History of seizure\n* Any clinical history of hematologic diseases including leukemia, myelodysplasia, myeloproliferative disease, thromboembolic disease, sickle cell disorder, thrombocytopenia or leukopenia\n* Class II-IV heart failure, according to the New York Heart Association classification\n* Inadequate venous access for apheresis, as assessed at Screening 1\n* Current or planned systemic immunosuppressive or immunomodulatory medication\n* Taking warfarin, aspirin or any medication that is likely to affect platelet function or other aspects of blood coagulation, and unable to safely cease this medication for a period of 1 week prior, during, and 1 week after administration of G-CSF (a total period of 19 days)\n* Participation in any study involving any investigational drug or medical device within 30 days prior to Screening 1\n* Receipt of a vaccine for HIV-1 or any gene transfer product at any time\n* Prior treatment with recombinant G-CSF or busulfan or other stem-cell mobilizing or modulating agent within the previous 12 months\n* Known hypersensitivity to busulfan, G-CSF (Neupogen™) or E. coli-derived proteins\n* Subjects who will not accept transfusions of blood products\n* Pregnant or breast-feeding at any time between Screening 1 and Baseline (infusion)\n* History of alcohol or drug abuse within the 12 months prior to Screening 1\n* Inability to understand and provide informed consent"}, 'identificationModule': {'nctId': 'NCT01734850', 'briefTitle': 'Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1 Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Calimmune, Inc.'}, 'officialTitle': 'An Adaptive Phase I/II Study of the Safety of CD4+ T Lymphocytes and CD34+ Hematopoietic Stem/Progenitor Cells Transduced With LVsh5/C46, a Dual Anti-HIV Gene Transfer Construct, With and Without Conditioning With Busulfan in HIV-1 Infected Adults Previously Exposed to ART', 'orgStudyIdInfo': {'id': 'CAL-USA-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'No busulfan pre-conditioning', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes without busulfan preconditioning', 'interventionNames': ['Biological: Cal-1 modified HSPC', 'Biological: Cal-1 modified CD4+ T lymphocytes']}, {'type': 'EXPERIMENTAL', 'label': '1 x 4mg/kg busulfan preconditioning', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes, with single 4mg/kg busulfan dose administered as pre-conditioning for transplant', 'interventionNames': ['Drug: Busulfan', 'Biological: Cal-1 modified HSPC', 'Biological: Cal-1 modified CD4+ T lymphocytes']}, {'type': 'EXPERIMENTAL', 'label': '2 x 4mg/kg busulfan pre-conditioning', 'description': 'Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes, with two 4mg/kg busulfan doses administered as pre-conditioning for transplant', 'interventionNames': ['Drug: Busulfan', 'Biological: Cal-1 modified HSPC', 'Biological: Cal-1 modified CD4+ T lymphocytes']}], 'interventions': [{'name': 'Busulfan', 'type': 'DRUG', 'otherNames': ['Busulfex'], 'description': 'Intravenous busulfan', 'armGroupLabels': ['1 x 4mg/kg busulfan preconditioning', '2 x 4mg/kg busulfan pre-conditioning']}, {'name': 'Cal-1 modified HSPC', 'type': 'BIOLOGICAL', 'otherNames': ['LVsh5/C46 modified HSPC'], 'description': 'Hematopoietic progenitor/stem cells (HSPC) modified with LVsh5/C46 (Cal-1)', 'armGroupLabels': ['1 x 4mg/kg busulfan preconditioning', '2 x 4mg/kg busulfan pre-conditioning', 'No busulfan pre-conditioning']}, {'name': 'Cal-1 modified CD4+ T lymphocytes', 'type': 'BIOLOGICAL', 'otherNames': ['LVsh5/C46 modified CD4+ T lymphocytes'], 'description': 'CD4+ T lymphocytes modified with LVsh5/C46 (Cal-1)', 'armGroupLabels': ['1 x 4mg/kg busulfan preconditioning', '2 x 4mg/kg busulfan pre-conditioning', 'No busulfan pre-conditioning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA CARE Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Quest Clinical Research', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Ronald Mitsuyasu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Calimmune, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}