Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2026-01-21 @ 11:37 PM
Study NCT ID:
NCT03002012
Status:
TERMINATED
Last Update Posted:
2020-06-09
First Post:
2016-12-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cryptococcal Antigen Screening Plus Sertraline
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003453', 'term': 'Cryptococcosis'}, {'id': 'D017088', 'term': 'AIDS-Related Opportunistic Infections'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D009894', 'term': 'Opportunistic Infections'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020280', 'term': 'Sertraline'}, {'id': 'D015725', 'term': 'Fluconazole'}], 'ancestors': [{'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'boulw001@umn.edu', 'phone': '612-624-1966', 'title': 'David Boulware', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Trial was terminated early by the NIAID DSMB for excess harm.'}}, 'adverseEventsModule': {'timeFrame': 'Through week 24', 'eventGroups': [{'id': 'EG000', 'title': 'Sertraline', 'description': 'Fluconazole Standard of Care + Sertraline\n\nSertraline: sertraline 400mg/day\n\nFluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 4, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Control', 'description': 'Fluconazole Standard of Care + Placebo Oral Tablet\n\nPlacebo Oral Tablet: matched placebo tablet\n\nFluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Acute Gastrointestinal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mania with Psychotic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Meningitis', 'notes': 'Meningitis complicated by CSF leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychosis with Serotonin Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'notes': 'Death due to probable meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '6 Month Meningitis-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sertraline', 'description': 'Fluconazole Standard of Care + Sertraline\n\nSertraline: sertraline 400mg/day\n\nFluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).'}, {'id': 'OG001', 'title': 'Control', 'description': 'Fluconazole Standard of Care + Placebo Oral Tablet\n\nPlacebo Oral Tablet: matched placebo tablet\n\nFluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Cryptococcal meningitis free survival with retention-in-care through 6 months\n\n* Those who die of any cause are failures\n* Those developing symptomatic cryptococcal meningitis are failures\n* Those lost to follow up and unable to be tracked are considered failures', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '6-month Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sertraline', 'description': 'Fluconazole Standard of Care + Sertraline\n\nSertraline: sertraline 400mg/day\n\nFluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).'}, {'id': 'OG001', 'title': 'Control', 'description': 'Fluconazole Standard of Care + Placebo Oral Tablet\n\nPlacebo Oral Tablet: matched placebo tablet\n\nFluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Survival through 6 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Symptomatic Cryptococcal Meningoencephalitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sertraline', 'description': 'Fluconazole Standard of Care + Sertraline\n\nSertraline: sertraline 400mg/day\n\nFluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).'}, {'id': 'OG001', 'title': 'Control', 'description': 'Fluconazole Standard of Care + Placebo Oral Tablet\n\nPlacebo Oral Tablet: matched placebo tablet\n\nFluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Cumulative incidence of symptomatic cryptococcal meningoencephalitis through 6 months', 'unitOfMeasure': 'meningitis events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Clinical Adverse Events (Grade 3-5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sertraline', 'description': 'Fluconazole Standard of Care + Sertraline\n\nSertraline: sertraline 400mg/day\n\nFluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).'}, {'id': 'OG001', 'title': 'Control', 'description': 'Fluconazole Standard of Care + Placebo Oral Tablet\n\nPlacebo Oral Tablet: matched placebo tablet\n\nFluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Number of Clinical Adverse Events by Division of AIDS (DAIDS) Scale for Grade 3-5 events through 6 months', 'unitOfMeasure': 'number of grade 3-5 adverse events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Laboratory Grade 3-5 Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sertraline', 'description': 'Fluconazole Standard of Care + Sertraline\n\nSertraline: sertraline 400mg/day\n\nFluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).'}, {'id': 'OG001', 'title': 'Control', 'description': 'Fluconazole Standard of Care + Placebo Oral Tablet\n\nPlacebo Oral Tablet: matched placebo tablet\n\nFluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Number of Laboratory Grade 3-5 Adverse Events through 6 months as per the Division of AIDS (DAIDS) grading scale', 'unitOfMeasure': 'number of grade 3-5 adverse events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'All-Cause Premature Study Drug/Placebo Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sertraline', 'description': 'Fluconazole Standard of Care + Sertraline\n\nSertraline: sertraline 400mg/day\n\nFluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).'}, {'id': 'OG001', 'title': 'Control', 'description': 'Fluconazole Standard of Care + Placebo Oral Tablet\n\nPlacebo Oral Tablet: matched placebo tablet\n\nFluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Number of participants whose study drug/placebo use was halted prematurely due to any cause through 6 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Prevalence of Depression by Patient Health Questionnaire (PHQ-9) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sertraline', 'description': 'Fluconazole Standard of Care + Sertraline\n\nSertraline: sertraline 400mg/day\n\nFluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).'}, {'id': 'OG001', 'title': 'Control', 'description': 'Fluconazole Standard of Care + Placebo Oral Tablet\n\nPlacebo Oral Tablet: matched placebo tablet\n\nFluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '7'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '7'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '9'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '7'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'description': 'Prevalence of depression by Patient Health Questionnaire (PHQ-9) over 6 months as measured at baseline, 4 weeks, 8 weeks, and 12 weeks. The PHQ-9 is a 9-item instrument for screening, diagnosing, monitoring, and measuring the severity of depression. Items are rated on a scale from 0 (not at all) to 3 (nearly every day). Total score is a sum of 9 item scores (Range 0-27). Greater scores indicate greater depressive symptoms. PHQ-9 scores of: 0-4 Minimal/No depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderate severe depression; 20-27 Severe depression. This endpoint reports the median (interquartile range) of the PHQ-9 scores over time.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adherence to Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sertraline', 'description': 'Fluconazole Standard of Care + Sertraline\n\nSertraline: sertraline 400mg/day\n\nFluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).'}, {'id': 'OG001', 'title': 'Control', 'description': 'Fluconazole Standard of Care + Placebo Oral Tablet\n\nPlacebo Oral Tablet: matched placebo tablet\n\nFluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '96', 'upperLimit': '100'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97', 'upperLimit': '100'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '88', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '96', 'upperLimit': '100'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '63', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'description': "Participants' percent adherence to study drug regiment by pharmacy medication counts, representing the percent of the total prescribed medication taken by participants.", 'unitOfMeasure': 'Percent of total prescribed medication t', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sertraline', 'description': 'Fluconazole Standard of Care + Sertraline\n\nSertraline: sertraline 400mg/day\n\nFluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).'}, {'id': 'FG001', 'title': 'Control', 'description': 'Fluconazole Standard of Care + Placebo Oral Tablet\n\nPlacebo Oral Tablet: matched placebo tablet\n\nFluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sertraline', 'description': 'Fluconazole Standard of Care + Sertraline\n\nSertraline: sertraline 400mg/day\n\nFluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).'}, {'id': 'BG001', 'title': 'Control', 'description': 'Fluconazole Standard of Care + Placebo Oral Tablet\n\nPlacebo Oral Tablet: matched placebo tablet\n\nFluconazole: Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '32'}, {'value': '35', 'groupId': 'BG001', 'lowerLimit': '32', 'upperLimit': '38'}, {'value': '32', 'groupId': 'BG002', 'lowerLimit': '29', 'upperLimit': '35'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Uganda', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'On Antiretroviral Therapy (ART) at Radomization', 'classes': [{'categories': [{'title': 'On ART', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Not on ART', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CD4 Cell Count', 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000', 'lowerLimit': '12', 'upperLimit': '86'}, {'value': '50', 'groupId': 'BG001', 'lowerLimit': '7', 'upperLimit': '83'}, {'value': '42', 'groupId': 'BG002', 'lowerLimit': '7', 'upperLimit': '86'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells/mm3', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-10', 'size': 1504019, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-07-24T13:05', 'hasProtocol': True}, {'date': '2017-09-06', 'size': 292281, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-07-24T13:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'whyStopped': 'SAEs with n=1 serotonin syndrome, n=2 SAEs after sertraline interruption.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-02', 'studyFirstSubmitDate': '2016-12-14', 'resultsFirstSubmitDate': '2019-07-24', 'studyFirstSubmitQcDate': '2016-12-20', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-10', 'studyFirstPostDateStruct': {'date': '2016-12-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adherence to Study Drug', 'timeFrame': '12 weeks', 'description': "Participants' percent adherence to study drug regiment by pharmacy medication counts, representing the percent of the total prescribed medication taken by participants."}], 'primaryOutcomes': [{'measure': '6 Month Meningitis-free Survival', 'timeFrame': '6 months', 'description': 'Cryptococcal meningitis free survival with retention-in-care through 6 months\n\n* Those who die of any cause are failures\n* Those developing symptomatic cryptococcal meningitis are failures\n* Those lost to follow up and unable to be tracked are considered failures'}], 'secondaryOutcomes': [{'measure': '6-month Survival', 'timeFrame': '6 months', 'description': 'Survival through 6 months'}, {'measure': 'Cumulative Incidence of Symptomatic Cryptococcal Meningoencephalitis', 'timeFrame': '6 months', 'description': 'Cumulative incidence of symptomatic cryptococcal meningoencephalitis through 6 months'}, {'measure': 'Number of Clinical Adverse Events (Grade 3-5)', 'timeFrame': '6 months', 'description': 'Number of Clinical Adverse Events by Division of AIDS (DAIDS) Scale for Grade 3-5 events through 6 months'}, {'measure': 'Number of Laboratory Grade 3-5 Adverse Events', 'timeFrame': '6 months', 'description': 'Number of Laboratory Grade 3-5 Adverse Events through 6 months as per the Division of AIDS (DAIDS) grading scale'}, {'measure': 'All-Cause Premature Study Drug/Placebo Discontinuation', 'timeFrame': '6 months', 'description': 'Number of participants whose study drug/placebo use was halted prematurely due to any cause through 6 months'}, {'measure': 'Prevalence of Depression by Patient Health Questionnaire (PHQ-9) Over Time', 'timeFrame': '12 weeks', 'description': 'Prevalence of depression by Patient Health Questionnaire (PHQ-9) over 6 months as measured at baseline, 4 weeks, 8 weeks, and 12 weeks. The PHQ-9 is a 9-item instrument for screening, diagnosing, monitoring, and measuring the severity of depression. Items are rated on a scale from 0 (not at all) to 3 (nearly every day). Total score is a sum of 9 item scores (Range 0-27). Greater scores indicate greater depressive symptoms. PHQ-9 scores of: 0-4 Minimal/No depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderate severe depression; 20-27 Severe depression. This endpoint reports the median (interquartile range) of the PHQ-9 scores over time.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cryptococcal antigen', 'preemptive treatment', 'CRAG+', 'sertraline', 'fluconazole', 'randomized clinical trial', 'HIV'], 'conditions': ['Cryptococcosis', 'Cryptococcal Infections', 'AIDS-Related Opportunistic Infections']}, 'referencesModule': {'references': [{'pmid': '32415846', 'type': 'RESULT', 'citation': 'Boulware DR, Nalintya E, Rajasingham R, Kirumira P, Naluyima R, Turya F, Namanda S, Rutakingirwa MK, Skipper CP, Nikweri Y, Hullsiek KH, Bangdiwala AS, Meya DB. Adjunctive sertraline for asymptomatic cryptococcal antigenemia: A randomized clinical trial. Med Mycol. 2020 Nov 10;58(8):1037-1043. doi: 10.1093/mmy/myaa033.'}], 'seeAlsoLinks': [{'url': 'http://preventcrypto.org', 'label': 'PreventCrypto.org has information and training materials for cryptococcal antigen screening and treatment'}]}, 'descriptionModule': {'briefSummary': 'Cryptococcal meningitis or "Crypto" is a life threatening fungal infection around the brain that requires hospitalization for treatment for 14 days and then continued therapy. Crypto causes 15-20% of HIV/AIDS-related deaths worldwide. However, this infection can be detected before one develops symptoms and becomes ill. People can be screened for infection by a blood test to detect "cryptococcal antigen," (called CrAg), which is part of the fungus, in blood. The World Health Organization and over 22 countries worldwide recommend CrAg screening of all persons with advanced AIDS entering or re-entering into HIV care.\n\nHowever, it is not known how best to treat people with cryptococcal antigen in their blood, who don\'t otherwise yet have symptoms of infection around their brain. If no treatment is given, almost all people will develop infection of the brain and/or die. International guidelines suggest using both HIV medicines and an anti-fungal medicine, called fluconazole, to treat this early infection. However, despite this treatment approximately 1 in 4 people may get sick and/or die.\n\nResearchers have recently discovered another medicine that may work against the Cryptococcus fungus. This medicine is called Sertraline, and it is actually a medicine that has been used for more than 25 years to treat depression (sadness). Sertraline is one of the most commonly used medicines worldwide.\n\nThe purpose of this research clinical trial is to determine if standard fluconazole antifungal therapy plus a high dose of Sertraline, will be better than standard fluconazole therapy alone for treating early disseminated cryptococcal infection in persons who are asymptomatic and do not yet have infection of the brain (i.e. meningitis).\n\nThis study seeks to test if Sertraline will improve survival through 6-months. Prior studies have shown that \\>90% of those who survive 6-months will survive \\>5 years.', 'detailedDescription': 'This is a double-blind, randomized placebo-controlled clinical trial testing sertraline as an antifungal medicine in combination with fluconazole for treatment of HIV-infected persons with AIDS and asymptomatic cryptococcal antigenemia (CrAg+).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-infected\n* Cryptococcal antigen (CrAg) positive in blood\n* Age \\>=18 years\n* Written informed consent\n* Women of childbearing potential who are participating in sexual activity that could lead to pregnancy must agree to use one reliable method of contraception while receiving fluconazole \\>=400mg/day\n\nExclusion Criteria:\n\n* Prior history of cryptococcal meningitis\n* Suspected meningitis or mania\n* Suspected/known cirrhosis, jaundice, or alanine aminotransferase (ALT) \\>5x upper limit of normal\n* Receiving an antidepressant medicine\n* Receiving antifungal therapy, \\>1 week\n* Pregnant or Breastfeeding\n* Contraindication to sertraline or fluconazole\n* Current rifampin use or other prohibited medication\n* Electrocardiogram corrected QT interval (QTc) \\>450ms'}, 'identificationModule': {'nctId': 'NCT03002012', 'acronym': 'C-ASSERT', 'briefTitle': 'Cryptococcal Antigen Screening Plus Sertraline', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Cryptococcal Antigen Screening Plus Sertraline', 'orgStudyIdInfo': {'id': 'U01AI125003', 'link': 'https://reporter.nih.gov/quickSearch/U01AI125003', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'U01AI125003', 'link': 'https://reporter.nih.gov/quickSearch/U01AI125003', 'type': 'NIH'}, {'id': '33238', 'type': 'OTHER', 'domain': 'DAIDS-ES ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sertraline', 'description': 'Fluconazole Standard of Care + Sertraline', 'interventionNames': ['Drug: Sertraline', 'Drug: Fluconazole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Fluconazole Standard of Care + Placebo Oral Tablet', 'interventionNames': ['Drug: Placebo Oral Tablet', 'Drug: Fluconazole']}], 'interventions': [{'name': 'Sertraline', 'type': 'DRUG', 'otherNames': ['Zoloft', 'Lustral', 'Sertraline hydrochloride'], 'description': 'sertraline 400mg/day', 'armGroupLabels': ['Sertraline']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'matched placebo tablet', 'armGroupLabels': ['Control']}, {'name': 'Fluconazole', 'type': 'DRUG', 'otherNames': ['Fluconazole 200mg tab'], 'description': 'Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).', 'armGroupLabels': ['Control', 'Sertraline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22418', 'city': 'Kampala', 'country': 'Uganda', 'facility': 'Infectious Disease Institute, Makerere University', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}], 'overallOfficials': [{'name': 'Elizabeth K Nalintya, MBChB MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Infectious Disease Institute'}, {'name': 'Radha Rajasingham, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Available for at least 5 years', 'ipdSharing': 'YES', 'description': 'A formal written data sharing plan exists. Protocol and trial documents can be shared. De-identified data can be shared after trial completion.', 'accessCriteria': 'Upon request to the Principal Investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'Infectious Diseases Institute, Uganda', 'class': 'OTHER'}, {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'Mbarara University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}