Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-01 @ 4:57 PM
Study NCT ID:
NCT01969058
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2013-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Isotretinoin on Immune Activation Among HIV-1 Infected Subjects With Incomplete CD4+ T Cell Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015474', 'term': 'Isotretinoin'}], 'ancestors': [{'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ACTGCT.Gov@s-3.com', 'phone': '(301) 628-3313', 'title': 'ACTG Clinicaltrials.gov Coordinator', 'organization': 'ACTG Network Coordinating Center, Social and Scientific Systems, Inc.'}, 'certainAgreement': {'otherDetails': 'In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) reported from study enrollment until study completion at 28 weeks', 'description': 'Expedited adverse event (EAE) reporting followed the Division of AIDS (DAIDS) EAE Manual under the SAE Reporting Category and including fetal losses. Events were graded (1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death) according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, Clarification Aug 2009.', 'eventGroups': [{'id': 'EG000', 'title': 'Isotretinoin', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 41, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'No Study Treatment', 'description': 'No Isotretinoin treatment', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 18, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood bicarbonate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lipase abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Low density lipoprotein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Meningitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in CD8+ T-cell Activation From Baseline to Week 14/16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'No Study Treatment Arm', 'description': 'No Isotretinoin treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '3.24', 'groupId': 'OG000', 'lowerLimit': '0.77', 'upperLimit': '7.75'}, {'value': '0.52', 'groupId': 'OG001', 'lowerLimit': '-0.41', 'upperLimit': '2.86'}]}]}], 'analyses': [{'pValue': '0.030', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Not adjusted for multiple comparisons.', 'groupDescription': 'Null hypothesis: There is no difference between the two arms in the change in T-cell activation from baseline to week 14/16.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, week 14/16', 'description': 'Level of CD8+ T-cell activation was determined by measuring the percentage of CD8+ T-cells that expressed both the activation marker CD38+ and Human leukocyte antigen (HLA)-DR+. The endpoint is measuring the change from baseline to week 14/16, where baseline is defined as the average of pre-entry and entry, and week 14/16 is defined as the average of week 14 and week 16.\n\nChange = (week 14/16 - baseline).', 'unitOfMeasure': 'percentage of cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis is complete case as-treated, and is limited to participants who:\n\n* have data for both baseline and week 14/16\n* (for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)\n* did not use prohibited medications\n* did not experience virologic failure from baseline to week 16'}, {'type': 'SECONDARY', 'title': 'Change in CD8+ T-cell Activation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'No Study Treatment Arm', 'description': 'No Isotretinoin treatment'}], 'classes': [{'title': 'Change from week 14/16 to week 28', 'categories': [{'measurements': [{'value': '-3.58', 'groupId': 'OG000', 'lowerLimit': '-8.45', 'upperLimit': '0.35'}, {'value': '-0.91', 'groupId': 'OG001', 'lowerLimit': '-3.40', 'upperLimit': '1.49'}]}]}, {'title': 'Change from baseline to week 28', 'categories': [{'measurements': [{'value': '-0.69', 'groupId': 'OG000', 'lowerLimit': '-2.61', 'upperLimit': '4.00'}, {'value': '0.03', 'groupId': 'OG001', 'lowerLimit': '-2.34', 'upperLimit': '3.32'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'Level of CD8+ T-cell activation was determined by measuring the percentage of CD8+ T-cells that expressed both the activation marker CD38+ and Human leukocyte antigen (HLA)-DR+.\n\nThe endpoint is measuring the change from week 14/16 to week 28 (week 28 - week 14/16) and from baseline to week 28 (week 28 - baseline).\n\nBaseline is defined as the average of pre-entry and entry, and week 14/16 is defined as the average of week 14 and week 16.', 'unitOfMeasure': 'percentage of cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is complete case as-treated, and is limited to participants who:\n\n* have data for both baseline and week 14/16\n* (for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)\n* did not use prohibited medications\n* did not experience virologic failure from baseline to week 16'}, {'type': 'SECONDARY', 'title': 'Change in sCD14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'No Study Treatment Arm', 'description': 'No Isotretinoin treatment'}], 'classes': [{'title': 'Change from baseline to week 14/16', 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '-0.03', 'upperLimit': '0.10'}, {'value': '-0.02', 'groupId': 'OG001', 'lowerLimit': '-0.06', 'upperLimit': '0.05'}]}]}, {'title': 'Change from week 14/16 to week 28', 'categories': [{'measurements': [{'value': '-0.06', 'groupId': 'OG000', 'lowerLimit': '-0.13', 'upperLimit': '0.02'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '-0.04', 'upperLimit': '0.06'}]}]}, {'title': 'Change from baseline to week 28', 'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000', 'lowerLimit': '-0.07', 'upperLimit': '0.05'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.06', 'upperLimit': '0.05'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'sCD14 (soluble cluster of differentiation 14) is a marker of gut microbial translocation and monocyte activation.\n\nThe outcome measures are changes in log10 transformed sCD14 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.', 'unitOfMeasure': 'log10 pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is complete case as-treated, and is limited to participants who:\n\n* have data for both baseline and week 14/16\n* (for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)\n* did not use prohibited medications\n* did not experience virologic failure from baseline to week 16'}, {'type': 'SECONDARY', 'title': 'Change in I-FABP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'No Study Treatment Arm', 'description': 'No Isotretinoin treatment'}], 'classes': [{'title': 'Change from baseline to week 14/16', 'categories': [{'measurements': [{'value': '-0.03', 'groupId': 'OG000', 'lowerLimit': '-0.14', 'upperLimit': '0.10'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '-0.05', 'upperLimit': '0.17'}]}]}, {'title': 'Change from week 14/16 to week 28', 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000', 'lowerLimit': '-0.01', 'upperLimit': '0.16'}, {'value': '-0.05', 'groupId': 'OG001', 'lowerLimit': '-0.15', 'upperLimit': '0.05'}]}]}, {'title': 'Change from baseline to week 28', 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '-0.05', 'upperLimit': '0.20'}, {'value': '-0.07', 'groupId': 'OG001', 'lowerLimit': '-0.19', 'upperLimit': '0.11'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'I-FABP (intestinal-fatty acid binding protein) is a marker of intestinal cell damage and turnover.\n\nThe outcome measures are changes in log10 transformed I-FABP from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.', 'unitOfMeasure': 'log10 pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is complete case as-treated, and is limited to participants who:\n\n* have data for both baseline and week 14/16\n* (for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)\n* did not use prohibited medications\n* did not experience virologic failure from baseline to week 16'}, {'type': 'SECONDARY', 'title': 'Change in IL-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'No Study Treatment Arm', 'description': 'No Isotretinoin treatment'}], 'classes': [{'title': 'Change from baseline to week 14/16', 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '-0.02', 'upperLimit': '0.19'}, {'value': '-0.04', 'groupId': 'OG001', 'lowerLimit': '-0.11', 'upperLimit': '0.05'}]}]}, {'title': 'Change from week 14/16 to week 28', 'categories': [{'measurements': [{'value': '-0.08', 'groupId': 'OG000', 'lowerLimit': '-0.27', 'upperLimit': '0.03'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '-0.07', 'upperLimit': '0.13'}]}]}, {'title': 'Change from baseline to week 28', 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '-0.14', 'upperLimit': '0.17'}, {'value': '-0.01', 'groupId': 'OG001', 'lowerLimit': '-0.14', 'upperLimit': '0.16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'IL-6 (Interleukin-6) is a marker of systemic inflammation. The outcome measures are changes in log10 transformed IL-6 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.', 'unitOfMeasure': 'log10 pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is complete case as-treated, and is limited to participants who:\n\n* have data for both baseline and week 14/16\n* (for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)\n* did not use prohibited medications\n* did not experience virologic failure from baseline to week 16'}, {'type': 'SECONDARY', 'title': 'Change in hsCRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'No Study Treatment Arm', 'description': 'No Isotretinoin treatment'}], 'classes': [{'title': 'Change from baseline to week 14/16', 'categories': [{'measurements': [{'value': '0.20', 'groupId': 'OG000', 'lowerLimit': '-0.07', 'upperLimit': '0.32'}, {'value': '-0.08', 'groupId': 'OG001', 'lowerLimit': '-0.21', 'upperLimit': '0.19'}]}]}, {'title': 'Change from week 14/16 to week 28', 'categories': [{'measurements': [{'value': '-0.24', 'groupId': 'OG000', 'lowerLimit': '-0.52', 'upperLimit': '-0.06'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '-0.06', 'upperLimit': '0.31'}]}]}, {'title': 'Change from baseline to week 28', 'categories': [{'measurements': [{'value': '-0.09', 'groupId': 'OG000', 'lowerLimit': '-0.39', 'upperLimit': '0.18'}, {'value': '-0.05', 'groupId': 'OG001', 'lowerLimit': '-0.15', 'upperLimit': '0.29'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'hsCRP (high-sensitivity C-reactive protein) is a marker of inflammation. Change in log10 transformed hsCRP from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.', 'unitOfMeasure': 'log10 ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is complete case as-treated, and is limited to participants who:\n\n* have data for both baseline and week 14/16\n* (for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)\n* did not use prohibited medications\n* did not experience virologic failure from baseline to week 16'}, {'type': 'SECONDARY', 'title': 'Change in sTNF-r1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'No Study Treatment Arm', 'description': 'No Isotretinoin treatment'}], 'classes': [{'title': 'Change from baseline to week 14/16', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.02', 'upperLimit': '0.03'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '-0.03', 'upperLimit': '0.05'}]}]}, {'title': 'Change from week 14/16 to week 28', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.04', 'upperLimit': '0.02'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.03', 'upperLimit': '0.04'}]}]}, {'title': 'Change from baseline to week 28', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.04', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '-0.03', 'upperLimit': '0.04'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'sTNF-r1 (soluble tumour necrosis alpha receptor 1) is a marker of inflammation. Change in log10 transformed sTNF-r1 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.', 'unitOfMeasure': 'log10 pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is complete case as-treated, and is limited to participants who:\n\n* have data for both baseline and week 14/16\n* (for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)\n* did not use prohibited medications\n* did not experience virologic failure from baseline to week 16'}, {'type': 'SECONDARY', 'title': 'Change in sTNF-r2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'No Study Treatment Arm', 'description': 'No Isotretinoin treatment'}], 'classes': [{'title': 'Change from baseline to week 14/16', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '-0.02', 'upperLimit': '0.07'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '-0.02', 'upperLimit': '0.05'}]}]}, {'title': 'Change from week 14/16 to week 28', 'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000', 'lowerLimit': '-0.08', 'upperLimit': '0.03'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.04', 'upperLimit': '0.04'}]}]}, {'title': 'Change from baseline to week 28', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.03', 'upperLimit': '0.04'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '-0.02', 'upperLimit': '0.06'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'sTNF-r2 (soluble tumour necrosis alpha receptor 2) is a marker of inflammation. Change in log10 transformed sTNF-r2 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.', 'unitOfMeasure': 'log10 pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is complete case as-treated, and is limited to participants who:\n\n* have data for both baseline and week 14/16\n* (for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)\n* did not use prohibited medications\n* did not experience virologic failure from baseline to week 16'}, {'type': 'SECONDARY', 'title': 'Change in D-dimer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'No Study Treatment Arm', 'description': 'No Isotretinoin treatment'}], 'classes': [{'title': 'Change from baseline to week 14/16', 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.20'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '-0.05', 'upperLimit': '0.15'}]}]}, {'title': 'Change from week 14/16 to week 28', 'categories': [{'measurements': [{'value': '-0.04', 'groupId': 'OG000', 'lowerLimit': '-0.22', 'upperLimit': '0.03'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.04', 'upperLimit': '0.07'}]}]}, {'title': 'Change from baseline to week 28', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000', 'lowerLimit': '-0.07', 'upperLimit': '0.14'}, {'value': '0.09', 'groupId': 'OG001', 'lowerLimit': '-0.05', 'upperLimit': '0.14'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'D-dimer (or D dimer) is a marker of coagulation activation. Change in log10 transformed D-dimer from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.', 'unitOfMeasure': 'log10 ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is complete case as-treated, and is limited to participants who:\n\n* have data for both baseline and week 14/16\n* (for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)\n* did not use prohibited medications\n* did not experience virologic failure from baseline to week 16'}, {'type': 'SECONDARY', 'title': 'Change in TF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'No Study Treatment Arm', 'description': 'No Isotretinoin treatment'}], 'classes': [{'title': 'Change from baseline to week 14/16', 'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000', 'lowerLimit': '-0.02', 'upperLimit': '0.03'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '-0.02', 'upperLimit': '0.05'}]}]}, {'title': 'Change from week 14/16 to week 28', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.07', 'upperLimit': '0.03'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.04'}]}]}, {'title': 'Change from baseline to week 28', 'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000', 'lowerLimit': '-0.06', 'upperLimit': '0.03'}, {'value': '0.03', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.07'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'TF (Tissue Factor) is a marker of Coagulation. Change in log10 transformed TF from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.', 'unitOfMeasure': 'log10 pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is complete case as-treated, and is limited to participants who:\n\n* have data for both baseline and week 14/16\n* (for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)\n* did not use prohibited medications\n* did not experience virologic failure from baseline to week 16'}, {'type': 'SECONDARY', 'title': 'Change in sCD163', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'No Study Treatment Arm', 'description': 'No Isotretinoin treatment'}], 'classes': [{'title': 'Change from baseline to week 14/16', 'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.22'}, {'value': '-0.01', 'groupId': 'OG001', 'lowerLimit': '-0.04', 'upperLimit': '0.12'}]}]}, {'title': 'Change from week 14/16 to week 28', 'categories': [{'measurements': [{'value': '-0.14', 'groupId': 'OG000', 'lowerLimit': '-0.19', 'upperLimit': '-0.05'}, {'value': '-0.01', 'groupId': 'OG001', 'lowerLimit': '-0.08', 'upperLimit': '0.05'}]}]}, {'title': 'Change from baseline to week 28', 'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000', 'lowerLimit': '-0.10', 'upperLimit': '0.15'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '-0.08', 'upperLimit': '0.21'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'sCD163 (soluble CD 163) is a marker of macrophage activation Change in log10 transformed sCD163 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.', 'unitOfMeasure': 'log10 ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is complete case as-treated, and is limited to participants who:\n\n* have data for both baseline and week 14/16\n* (for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)\n* did not use prohibited medications\n* did not experience virologic failure from baseline to week 16'}, {'type': 'SECONDARY', 'title': 'Change in CD4+ T-cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'No Study Treatment Arm', 'description': 'No Isotretinoin treatment'}], 'classes': [{'title': 'Change from baseline to week 14/16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '-35', 'upperLimit': '43'}, {'value': '-39', 'groupId': 'OG001', 'lowerLimit': '-124', 'upperLimit': '19'}]}]}, {'title': 'Change from week 14/16 to week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000', 'lowerLimit': '-10', 'upperLimit': '75'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '-31', 'upperLimit': '81'}]}]}, {'title': 'Change from baseline to week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '-18', 'upperLimit': '89'}, {'value': '-14', 'groupId': 'OG001', 'lowerLimit': '-76', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'Change in peripheral total CD4 cell count from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is complete case as-treated, and is limited to participants who:\n\n* have data for both baseline and week 14/16\n* (for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)\n* did not use prohibited medications\n* did not experience virologic failure from baseline to week 16'}, {'type': 'SECONDARY', 'title': 'Change in Cell-associated HIV-1 RNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'No Study Treatment Arm', 'description': 'No Isotretinoin treatment'}], 'classes': [{'title': 'Change from baseline to week 14/16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.09', 'groupId': 'OG000', 'lowerLimit': '-0.32', 'upperLimit': '0.24'}, {'value': '-0.02', 'groupId': 'OG001', 'lowerLimit': '-0.22', 'upperLimit': '0.25'}]}]}, {'title': 'Change from week 14/16 to week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'groupId': 'OG000', 'lowerLimit': '-0.28', 'upperLimit': '0.22'}, {'value': '-0.20', 'groupId': 'OG001', 'lowerLimit': '-0.51', 'upperLimit': '0.04'}]}]}, {'title': 'Change from baseline to week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.08', 'groupId': 'OG000', 'lowerLimit': '-0.28', 'upperLimit': '0.13'}, {'value': '-0.18', 'groupId': 'OG001', 'lowerLimit': '-0.46', 'upperLimit': '0.12'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'Cell-associated HIV-1 RNA in blood from baseline to week 14/16(week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.\n\nFor cell-associated HIV-1 RNA results below the assay limit, the lowest value of the sample was imputed to these results (1.32 log10 copies/10\\^6 CD4 cells).\n\nSince there are only a few results below the assay limit, it is still reasonable to summarize the absolute changes for cell-associated HIV-1 RNA, where changes were calculated based on the imputed values (described above) for below assay limit results.', 'unitOfMeasure': 'log10 copies/million CD4 cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is complete case as-treated, and is limited to participants who:\n\n* have data for both baseline and week 14/16\n* (for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)\n* did not use prohibited medications\n* did not experience virologic failure from baseline to week 16\n* have cell-associated HIV-1 RNA data'}, {'type': 'SECONDARY', 'title': 'Cell-associated HIV-1 DNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'No Study Treatment Arm', 'description': 'No Isotretinoin treatment'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.55', 'groupId': 'OG000', 'lowerLimit': '2.03', 'upperLimit': '2.99'}, {'value': '2.72', 'groupId': 'OG001', 'lowerLimit': '2.39', 'upperLimit': '2.94'}]}]}, {'title': 'week 14/16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.52', 'groupId': 'OG000', 'lowerLimit': '2.25', 'upperLimit': '2.79'}, {'value': '2.66', 'groupId': 'OG001', 'lowerLimit': '2.23', 'upperLimit': '2.88'}]}]}, {'title': 'week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.64', 'groupId': 'OG000', 'lowerLimit': '1.78', 'upperLimit': '2.95'}, {'value': '2.55', 'groupId': 'OG001', 'lowerLimit': '2.21', 'upperLimit': '2.82'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'Cell-associated HIV-1 DNA in blood at baseline, week 14/16, and week 28. Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.\n\nFor cell-associated HIV-1 DNA results below the assay limit, the lowest value of the sample was imputed to these results and considered lowest ranks (1.62 log10 copies/10\\^6 CD4 cells).\n\nIt was originally planned to summarize the absolute changes for cell-associated HIV-1 DNA. However, since there are many results below limit of detection, analyzing the absolute changes would be inappropriate in this case.\n\nInstead, the baseline, week 14/16, and week 28 levels were summarized.', 'unitOfMeasure': 'log10 copies/million CD4 cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is complete case as-treated, and is limited to participants who:\n\n* have data for both baseline and week 14/16\n* (for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)\n* did not use prohibited medications\n* did not experience virologic failure from baseline to week 16\n* have cell-associated HIV-1 DNA data'}, {'type': 'SECONDARY', 'title': 'Change in Treg Frequency (%FoxP3+/CD25hi+/CD39+/CD127-(CD4+))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'No Study Treatment Arm', 'description': 'No Isotretinoin treatment'}], 'classes': [{'title': 'Change from baseline to week 14/16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.46', 'upperLimit': '0.20'}, {'value': '-0.03', 'groupId': 'OG001', 'lowerLimit': '-0.29', 'upperLimit': '0.25'}]}]}, {'title': 'Change from week 14/16 to week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.28', 'upperLimit': '0.26'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '-0.11', 'upperLimit': '0.21'}]}]}, {'title': 'Change from baseline to week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'groupId': 'OG000', 'lowerLimit': '-0.36', 'upperLimit': '0.09'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '-0.26', 'upperLimit': '0.26'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'Treg (T Regulatory) Cells are a subpopulation of T cells which modulate the immune system.\n\nThe outcome measure is the change in percent FoxP3+/CD25hi+/CD39+/CD127-(CD4+) from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.', 'unitOfMeasure': 'percentage of CD4 cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is complete case as-treated, and is limited to participants who:\n\n* have data for both baseline and week 14/16\n* (for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)\n* did not use prohibited medications\n* did not experience virologic failure from baseline to week 16'}, {'type': 'SECONDARY', 'title': 'Change in Th17 Frequency (%IFNg-/IL17+(CD161+/CCR6+))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'No Study Treatment Arm', 'description': 'No Isotretinoin treatment'}], 'classes': [{'title': 'Change from baseline to week 14/16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'groupId': 'OG000', 'lowerLimit': '-0.42', 'upperLimit': '0.14'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '-0.31', 'upperLimit': '0.54'}]}]}, {'title': 'Change from week 14/16 to week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '-0.33', 'upperLimit': '0.28'}, {'value': '-0.07', 'groupId': 'OG001', 'lowerLimit': '-0.41', 'upperLimit': '0.18'}]}]}, {'title': 'Change from baseline to week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'groupId': 'OG000', 'lowerLimit': '-0.50', 'upperLimit': '0.14'}, {'value': '-0.01', 'groupId': 'OG001', 'lowerLimit': '-0.85', 'upperLimit': '0.52'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'Th17 (T-helper 17) cells are a subset of pro-inflammatory T helper cells defined by their production of interleukin 17 (IL-17).\n\nThe outcome is the change in percent IFNg-/IL17+(CD161+/CCR6+) from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.', 'unitOfMeasure': 'percentage of CD161+/CCR6+ cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is complete case as-treated, and is limited to participants who:\n\n* have data for both baseline and week 14/16\n* (for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)\n* did not use prohibited medications\n* did not experience virologic failure from baseline to week 16'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics - Endogenous Levels of Retinoid Metabolites for Isotretinoin Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}], 'classes': [{'title': 'Retinol', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '2.7'}]}]}, {'title': 'Total Retinyl Ester', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '0.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'weeks 0, 20, 28', 'description': 'Isotretinoin Arm (Arm A) only. Endogenous retinoid metabolites are defined as the average concentrations of Retinol, and Total Retinyl Ester from weeks 0, 20, and 28.', 'unitOfMeasure': 'nmol/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Included only Isotretinoin arm participants who were on Isotretinoin for 8 weeks of more.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics - Steady-state Trough Concentrations of Isotretinoin for Isotretinoin Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}], 'classes': [{'title': 'All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000', 'lowerLimit': '152', 'upperLimit': '263'}]}]}, {'title': 'With EFV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '228', 'groupId': 'OG000', 'lowerLimit': '120', 'upperLimit': '265'}]}]}, {'title': 'No EFV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '202', 'groupId': 'OG000', 'lowerLimit': '152', 'upperLimit': '241'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'weeks 8, 12, 16', 'description': "Isotretinoin arm (Arm A) only, steady-state trough concentrations of Isotretinoin is defined as the average of 'eligible' concentrations at weeks 8, 12, and 16, where 'eligible' means the time from the previous dose to the blood draw of the sample must have been in the 14-to-30 hour range, and the participant must have taken at least 3 doses in the prior 4 days.", 'unitOfMeasure': 'pmol/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Included only Isotretinoin arm participants who were on Isotretinoin for 8 weeks of more and have steady state troughs available.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics - Trough Concentrations of TDF for Isotretinoin Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}], 'classes': [{'title': 'With Isotretinoin', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000', 'lowerLimit': '52', 'upperLimit': '107'}]}]}, {'title': 'Without Isotretinoin', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '87'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'weeks 0, 8, 12, 16, 20', 'description': "Isotretinoin arm (Arm A) only, trough concentrations of TDF (Tenofovir) is defined as the average of 'eligible' concentrations, where 'eligible' means the time from the previous dose to the blood draw of the sample must have been in the 20-to-28 hour range, and the participant must have taken at least 3 doses in the prior 4 days.\n\nTDF trough during Isotretinoin administration is the average of 'eligible' concentrations from weeks 8, 12, and 16; TDF trough without Isotretinoin administration is the average of 'eligible' concentrations from weeks 0 and 20.\n\n(Week 28 data is not available.)", 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Included only Isotretinoin arm participants who were on TDF and on Isotretinoin for 8 weeks of more, and with available TDF trough.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics - 12-hour Levels of EFV for Isotretinoin Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}], 'classes': [{'title': 'With Isotretinoin', 'categories': [{'measurements': [{'value': '2607', 'groupId': 'OG000', 'lowerLimit': '1648', 'upperLimit': '4343'}]}]}, {'title': 'Without Isotretinoin', 'categories': [{'measurements': [{'value': '2665', 'groupId': 'OG000', 'lowerLimit': '1849', 'upperLimit': '3421'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'weeks 0, 8, 12, 16, 20', 'description': "Isotretinoin arm (Arm A) only, 12-hour levels of EFV (Efavirenz) is defined as the average of 'eligible' concentrations, where 'eligible' means the time from the previous dose to the blood draw of the sample must have been in the 9-to-15 hour range, and the participant must have taken at least 3 doses in the prior 4 days.\n\nEFV trough during Isotretinoin administration is the average of 'eligible' concentrations from weeks 8, 12, and 16; EFV trough without Isotretinoin administration is the average of 'eligible' concentrations from weeks 0 and 20.\n\n(Week 28 data is not available.)", 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Included only Isotretinoin arm participants who were on EFV and on Isotretinoin for 8 weeks of more, and with available EFV 12-hour levels.'}, {'type': 'SECONDARY', 'title': 'Primary Targeted Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'No Study Treatment Arm', 'description': 'No Isotretinoin treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from study entry to end of study (week 28)', 'description': 'Targeted events for A5325 include: events that meet the International Conference on Harmonization (ICH) definitions for a serious adverse event, post-entry signs/symptoms and laboratory abnormalities of Grade ≥3 or that lead to a change in treatment regardless of grade, and any diagnoses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all enrolled participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}, {'id': 'FG001', 'title': 'No Study Treatment Arm', 'description': 'No Isotretinoin treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First participant was enrolled on July 2, 2014. Accrual to the study closed on May 5, 2016, with 15 U.S and Puerto Rico sites registered and enrolled participants', 'preAssignmentDetails': 'Participants were randomized 2:1 to Isotretinoin and no study treatment arms. Randomization was stratified by willingness to participate in the gut biopsy substudy, A5330s.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.'}, {'id': 'BG001', 'title': 'No Study Treatment Arm', 'description': 'No Isotretinoin treatment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000', 'lowerLimit': '38', 'upperLimit': '55'}, {'value': '51', 'groupId': 'BG001', 'lowerLimit': '38', 'upperLimit': '53'}, {'value': '49', 'groupId': 'BG002', 'lowerLimit': '38', 'upperLimit': '55'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '18-39 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': '40-59 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': '>=60 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Non-Hispanic White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic (Regardless of Race)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Puerto Rico', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HIV-1 RNA', 'classes': [{'title': '>= Assay lower limit (40 copies/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': '< Assay lower limit (40 copies/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CD4+ Cell Count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '549', 'groupId': 'BG000', 'lowerLimit': '299', 'upperLimit': '754'}, {'value': '556', 'groupId': 'BG001', 'lowerLimit': '342', 'upperLimit': '781'}, {'value': '552', 'groupId': 'BG002', 'lowerLimit': '310', 'upperLimit': '768'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27.1', 'groupId': 'BG000', 'lowerLimit': '23.1', 'upperLimit': '29.3'}, {'value': '26.9', 'groupId': 'BG001', 'lowerLimit': '22.6', 'upperLimit': '27.9'}, {'value': '27.1', 'groupId': 'BG002', 'lowerLimit': '22.9', 'upperLimit': '29.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'CD8+ T-cell Activation Percent', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13.67', 'groupId': 'BG000', 'lowerLimit': '10.35', 'upperLimit': '19.49'}, {'value': '13.40', 'groupId': 'BG001', 'lowerLimit': '8.43', 'upperLimit': '18.56'}, {'value': '13.66', 'groupId': 'BG002', 'lowerLimit': '9.83', 'upperLimit': '19.29'}]}]}], 'paramType': 'MEDIAN', 'description': 'CD8+ T-cell activation percent is the primary endpoint. Level of CD8+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38+ and Human leukocyte antigen (HLA)-DR+.\n\nBaseline is defined as the average of pre-entry and entry values', 'unitOfMeasure': 'percentage of cells', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The primary endpoint is limited to participants who have data for both baseline and week 14/16, (for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses), did not use prohibited medications, and did not experience virologic failure from baseline to week 16.'}], 'populationDescription': 'All enrolled participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'open label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomized 2:1 to Isotretinoin arm and no study treatment arm. The primary endpoints were compared between the 2 study arms.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-01', 'studyFirstSubmitDate': '2013-08-21', 'resultsFirstSubmitDate': '2017-08-04', 'studyFirstSubmitQcDate': '2013-10-21', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-04', 'studyFirstPostDateStruct': {'date': '2013-10-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in CD8+ T-cell Activation From Baseline to Week 14/16', 'timeFrame': 'baseline, week 14/16', 'description': 'Level of CD8+ T-cell activation was determined by measuring the percentage of CD8+ T-cells that expressed both the activation marker CD38+ and Human leukocyte antigen (HLA)-DR+. The endpoint is measuring the change from baseline to week 14/16, where baseline is defined as the average of pre-entry and entry, and week 14/16 is defined as the average of week 14 and week 16.\n\nChange = (week 14/16 - baseline).'}], 'secondaryOutcomes': [{'measure': 'Change in CD8+ T-cell Activation', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'Level of CD8+ T-cell activation was determined by measuring the percentage of CD8+ T-cells that expressed both the activation marker CD38+ and Human leukocyte antigen (HLA)-DR+.\n\nThe endpoint is measuring the change from week 14/16 to week 28 (week 28 - week 14/16) and from baseline to week 28 (week 28 - baseline).\n\nBaseline is defined as the average of pre-entry and entry, and week 14/16 is defined as the average of week 14 and week 16.'}, {'measure': 'Change in sCD14', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'sCD14 (soluble cluster of differentiation 14) is a marker of gut microbial translocation and monocyte activation.\n\nThe outcome measures are changes in log10 transformed sCD14 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.'}, {'measure': 'Change in I-FABP', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'I-FABP (intestinal-fatty acid binding protein) is a marker of intestinal cell damage and turnover.\n\nThe outcome measures are changes in log10 transformed I-FABP from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.'}, {'measure': 'Change in IL-6', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'IL-6 (Interleukin-6) is a marker of systemic inflammation. The outcome measures are changes in log10 transformed IL-6 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.'}, {'measure': 'Change in hsCRP', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'hsCRP (high-sensitivity C-reactive protein) is a marker of inflammation. Change in log10 transformed hsCRP from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.'}, {'measure': 'Change in sTNF-r1', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'sTNF-r1 (soluble tumour necrosis alpha receptor 1) is a marker of inflammation. Change in log10 transformed sTNF-r1 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.'}, {'measure': 'Change in sTNF-r2', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'sTNF-r2 (soluble tumour necrosis alpha receptor 2) is a marker of inflammation. Change in log10 transformed sTNF-r2 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.'}, {'measure': 'Change in D-dimer', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'D-dimer (or D dimer) is a marker of coagulation activation. Change in log10 transformed D-dimer from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.'}, {'measure': 'Change in TF', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'TF (Tissue Factor) is a marker of Coagulation. Change in log10 transformed TF from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.'}, {'measure': 'Change in sCD163', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'sCD163 (soluble CD 163) is a marker of macrophage activation Change in log10 transformed sCD163 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.'}, {'measure': 'Change in CD4+ T-cell Count', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'Change in peripheral total CD4 cell count from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.'}, {'measure': 'Change in Cell-associated HIV-1 RNA', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'Cell-associated HIV-1 RNA in blood from baseline to week 14/16(week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.\n\nFor cell-associated HIV-1 RNA results below the assay limit, the lowest value of the sample was imputed to these results (1.32 log10 copies/10\\^6 CD4 cells).\n\nSince there are only a few results below the assay limit, it is still reasonable to summarize the absolute changes for cell-associated HIV-1 RNA, where changes were calculated based on the imputed values (described above) for below assay limit results.'}, {'measure': 'Cell-associated HIV-1 DNA', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'Cell-associated HIV-1 DNA in blood at baseline, week 14/16, and week 28. Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.\n\nFor cell-associated HIV-1 DNA results below the assay limit, the lowest value of the sample was imputed to these results and considered lowest ranks (1.62 log10 copies/10\\^6 CD4 cells).\n\nIt was originally planned to summarize the absolute changes for cell-associated HIV-1 DNA. However, since there are many results below limit of detection, analyzing the absolute changes would be inappropriate in this case.\n\nInstead, the baseline, week 14/16, and week 28 levels were summarized.'}, {'measure': 'Change in Treg Frequency (%FoxP3+/CD25hi+/CD39+/CD127-(CD4+))', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'Treg (T Regulatory) Cells are a subpopulation of T cells which modulate the immune system.\n\nThe outcome measure is the change in percent FoxP3+/CD25hi+/CD39+/CD127-(CD4+) from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.'}, {'measure': 'Change in Th17 Frequency (%IFNg-/IL17+(CD161+/CCR6+))', 'timeFrame': 'baseline, week 14/16, week 28', 'description': 'Th17 (T-helper 17) cells are a subset of pro-inflammatory T helper cells defined by their production of interleukin 17 (IL-17).\n\nThe outcome is the change in percent IFNg-/IL17+(CD161+/CCR6+) from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).\n\nLevels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.'}, {'measure': 'Pharmacokinetics - Endogenous Levels of Retinoid Metabolites for Isotretinoin Arm', 'timeFrame': 'weeks 0, 20, 28', 'description': 'Isotretinoin Arm (Arm A) only. Endogenous retinoid metabolites are defined as the average concentrations of Retinol, and Total Retinyl Ester from weeks 0, 20, and 28.'}, {'measure': 'Pharmacokinetics - Steady-state Trough Concentrations of Isotretinoin for Isotretinoin Arm', 'timeFrame': 'weeks 8, 12, 16', 'description': "Isotretinoin arm (Arm A) only, steady-state trough concentrations of Isotretinoin is defined as the average of 'eligible' concentrations at weeks 8, 12, and 16, where 'eligible' means the time from the previous dose to the blood draw of the sample must have been in the 14-to-30 hour range, and the participant must have taken at least 3 doses in the prior 4 days."}, {'measure': 'Pharmacokinetics - Trough Concentrations of TDF for Isotretinoin Arm', 'timeFrame': 'weeks 0, 8, 12, 16, 20', 'description': "Isotretinoin arm (Arm A) only, trough concentrations of TDF (Tenofovir) is defined as the average of 'eligible' concentrations, where 'eligible' means the time from the previous dose to the blood draw of the sample must have been in the 20-to-28 hour range, and the participant must have taken at least 3 doses in the prior 4 days.\n\nTDF trough during Isotretinoin administration is the average of 'eligible' concentrations from weeks 8, 12, and 16; TDF trough without Isotretinoin administration is the average of 'eligible' concentrations from weeks 0 and 20.\n\n(Week 28 data is not available.)"}, {'measure': 'Pharmacokinetics - 12-hour Levels of EFV for Isotretinoin Arm', 'timeFrame': 'weeks 0, 8, 12, 16, 20', 'description': "Isotretinoin arm (Arm A) only, 12-hour levels of EFV (Efavirenz) is defined as the average of 'eligible' concentrations, where 'eligible' means the time from the previous dose to the blood draw of the sample must have been in the 9-to-15 hour range, and the participant must have taken at least 3 doses in the prior 4 days.\n\nEFV trough during Isotretinoin administration is the average of 'eligible' concentrations from weeks 8, 12, and 16; EFV trough without Isotretinoin administration is the average of 'eligible' concentrations from weeks 0 and 20.\n\n(Week 28 data is not available.)"}, {'measure': 'Primary Targeted Adverse Events', 'timeFrame': 'from study entry to end of study (week 28)', 'description': 'Targeted events for A5325 include: events that meet the International Conference on Harmonization (ICH) definitions for a serious adverse event, post-entry signs/symptoms and laboratory abnormalities of Grade ≥3 or that lead to a change in treatment regardless of grade, and any diagnoses.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Isotretinoin', 'HIV-1', 'immunology markers', 'immune activation', 'viral suppression'], 'conditions': ['HIV-1 Infection']}, 'descriptionModule': {'briefSummary': 'This phase II study was done in HIV-infected participants on antiretroviral therapy to evaluate the effects of isotretinoin (a drug that is approved for use in the treatment of severe acne) on the immune system. The immune system helps the body fight infections. When the immune system is not working well, one may be at greater risk for diseases that are common in aging, like heart disease, weaker bones, and kidney disease.', 'detailedDescription': 'Isotretinoin was administered to participants in the Isotretinoin arm at approximately 0.5 mg/kg PO once daily for 4 weeks, then increased to approximately 1.0 mg/kg PO once daily for 12 weeks. Follow-up continues to week 28 to evaluate the duration of effect. Randomization was stratified by willingness to participate in the gut biopsy substudy, A5330s. The study population included HIV-1 infected adults whose virus was suppressed on ART, excluding women of child bearing potential.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.\n\nNOTE: The term "licensed" refers to a US FDA-approved kit, which is required for all IND studies.\n\nCDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (eg, indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.\n\n* Receiving ART therapy for at least 12 months prior to study entry.\n* No plans to change the ART regimen in the 6 months after study entry.\n* HIV-1 RNA below the lower limit of detection using an FDA-approved assay obtained within 30 days prior to study entry by any laboratory that has a CLIA certification or its equivalent (eg, \\<50 copies/mL on Roche Amplicor HIV-1 Monitor assay, \\<75 copies/mL on the Versant HIV-1 RNA assay by branched DNA, \\<40 copies/mL on the Abbott m2000sp/m2000rt real-time PCR test, \\< 20 copies/mL on the COBAS AmpliPrep/TAQMAN HIV-1 assay).\n* All measurements of HIV-1 RNA within the 12 months prior to study entry must be below the limit of detection with the following exception:\n\nNOTE A: 1 viral blip (\\<200 copies/mL) is permitted if it is preceded and followed by viral loads below the limits of detection.\n\nNOTE B: The virologic assay must have a lower limit of detection of ≤ 75 copies/mL.\n\n* CD4+ cell count \\<350 cells/mm3 obtained at screening within 30 days prior to entry at any laboratory that has a CLIA (Clinical Laboratory Improvement Amendments) certification or its equivalent.\n* The following laboratory values obtained within 30 days prior to entry by any laboratory that has a CLIA certification or its equivalent:\n\n 1. Hemoglobin A1c (HgbA1c) levels ≤ 6.5%\n 2. Hemoglobin ≥ 9.0 g/dL\n 3. Platelet count ≥ 50,000/mm3\n 4. Creatinine ≤1.5 mg/dl\n 5. CrCl ≥ 60 mL/min, calculated by the Cockcroft-Gault method\n 6. Aspartate aminotransferase (AST) (SGOT) ≤1.5x upper limit of normal (ULN)\n 7. Alanine aminotransferase (ALT) (SGPT) ≤1.5x ULN\n 8. Serum lipase ≤1.5x ULN\n 9. Fasting triglyceride level ≤200 mg/dL\n 10. Fasting glucose \\<126mg/dL\n* Karnofsky performance score \\>/=70 within 30 days prior to entry.\n* Men and post-menopausal females aged ≥ 18 years and ≤ 80 years at entry.\n\nNote: Post-menopausal is defined as having either:\n\n1. Appropriate medical documentation (see note) of prior complete bilateral oophorectomy (i.e., surgical removal of the ovaries, resulting in "surgical menopause" and occurring at the age at which the procedure was performed), OR\n2. Permanent cessation (12 consecutive months or more of amenorrhea) of previously occurring menses as a result of ovarian failure with documentation of hormonal deficiency by a certified healthcare provider (i.e., "spontaneous menopause").\n\nHormonal deficiency should be properly documented (see note) in the case of suspected spontaneous menopause as follows:\n\n1. If age \\>54 years and with the absence of normal menses: Serum FSH (Follicle Stimulating Hormone) level elevated to within the post-menopausal range based on the laboratory reference range where the hormonal assay is performed.\n2. If age ≤ 54 years and with the absence of normal menses: Negative serum or urine HCG with concurrently elevated serum FSH (follicle stimulating hormone) level in the post-menopausal range, depressed estradiol (E2) level in the post-menopausal range, and absent serum progesterone level, based on the laboratory reference ranges where the hormonal assays are performed.\n\nNOTE: "Appropriate documentation", and "properly documented" means written documentation or oral communication from a clinician or clinician\'s staff documented in source documents of an operative report, discharge summary, or\n\n* No active hepatitis B or C infection. NOTE: For subjects who have documentation of prior infection, but no active hepatitis infection, evidence of clearance must be greater than 1 year.\n* Ability and willingness of subject to provide informed consent.\n* Willingness to adhere to the iPLEDGE program requirements.\n* Indication of willingness to participate in the substudy A5330s. NOTE: In the event that 12 or fewer subjects have enrolled into A5330s by the time enrollment in the main study has reached 50% of the accrual target, A5330s enrollment will be required.\n\nExclusion Criteria:\n\n* Pre-existing diagnosis of diabetes.\n* Currently receiving treatment with fibrate, nicotinic acid, tetracycline, fish oil \\>1g/d, or methotrexate.\n* Known active healing fracture or any severe bone disorders. NOTE: does not include healed fractures or history of old fractures.\n* Receipt of any of the following medications within 30 days prior to entry: systemic steroids (including intra-articular steroids; inhaled or nasal steroid therapy is permitted), interleukins, systemic interferons (including intra-articular steroid injection; local injection of interferon alpha for treatment of human papilloma virus is permitted), or systemic chemotherapy.\n* Known allergy/sensitivity or any hypersensitivity to vitamin A, retinoids, or any of their derivatives.\n* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n* Acute or serious illness requiring systemic treatment and/or hospitalization within 60 days prior to entry.\n* Weight \\< 40 kg or \\> 150 kg.\n* History of major depression or suicide attempt requiring hospitalization, or psychotic episode requiring medication or hospitalization.\n* History of inflammatory bowel disease such as Crohn\'s disease, or Ulcerative colitis.'}, 'identificationModule': {'nctId': 'NCT01969058', 'briefTitle': 'Effect of Isotretinoin on Immune Activation Among HIV-1 Infected Subjects With Incomplete CD4+ T Cell Recovery', 'organization': {'class': 'NETWORK', 'fullName': 'Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections'}, 'officialTitle': 'A Prospective Randomized Controlled Study to Evaluate the Effect of Isotretinoin on Immune Activation Among HIV-1 Infected Subjects With Incomplete CD4+ T Cell Recovery on Suppressive Antiretroviral Therapy (ART)', 'orgStudyIdInfo': {'id': 'ACTG A5325'}, 'secondaryIdInfos': [{'id': 'UM1AI068636', 'link': 'https://reporter.nih.gov/quickSearch/UM1AI068636', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Isotretinoin Arm', 'description': 'Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.', 'interventionNames': ['Drug: Isotretinoin']}, {'type': 'NO_INTERVENTION', 'label': 'No study treatment Arm', 'description': 'No Isotretinoin treatment'}], 'interventions': [{'name': 'Isotretinoin', 'type': 'DRUG', 'otherNames': ['13-cis-retinoic acid'], 'description': 'Isotretinoin is a drug that is approved for use in the treatment of severe acne. The aim of this study is to evaluate the role of Isotretinoin on immune activation and inflammation.', 'armGroupLabels': ['Isotretinoin Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': '31788 Alabama CRS', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90035', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': '601 University of California, Los Angeles CARE Center CRS', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': '801 University of California, San Francisco HIV/AIDS CRS', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': '101 Massachusetts General Hospital (MGH) CRS', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "107 Brigham and Women's Hosp. ACTG CRS", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': '2101 Washington University Therapeutics (WT) CRS', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': '31786 New Jersey Medical School Clinical Research Center CRS', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': '31787 University of Rochester Adult HIV Therapeutic Strategies Network CRS', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27516', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': '3201 Chapel Hill CRS', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': '3203 Greensboro CRS', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '45267-0405', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': '2401 Cincinnati CRS', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': '2951 The Miriam Hospital (TMH) ACTG CRS', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '37204', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': '3652 Vanderbilt Therapeutics (VT) CRS', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': '31473 Houston AIDS Research Team (HART) CRS', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '00931', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': '5401 Puerto Rico AIDS Clinical Trials Unit CRS', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Douglas Kwon, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Massachusetts General Hospital'}, {'name': 'Nina Lin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Harvard Medical School (HMS and HSDM)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}