Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-27 @ 3:25 AM
Study NCT ID:
NCT01535469
Status:
COMPLETED
Last Update Posted:
2020-06-04
First Post:
2012-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Operational Research for Cryptococcal Antigen Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016919', 'term': 'Meningitis, Cryptococcal'}, {'id': 'D003453', 'term': 'Cryptococcosis'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D016921', 'term': 'Meningitis, Fungal'}, {'id': 'D020314', 'term': 'Central Nervous System Fungal Infections'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015725', 'term': 'Fluconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3049}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-02', 'studyFirstSubmitDate': '2012-02-10', 'studyFirstSubmitQcDate': '2012-02-16', 'lastUpdatePostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention in care', 'timeFrame': '6-month', 'description': '1. before/after CRAG screening implementation (All persons)\n2. CRAG positive persons treated with high-dose fluconazole as compared to 6-month survival of CRAG negative persons who are eligible for antiretroviral therapy.'}], 'secondaryOutcomes': [{'measure': 'Cryptococcal meningitis-free survival time', 'timeFrame': '6-month', 'description': 'Cryptococcal meningitis-free survival time in those who are asymptomatic CRAG positive and treated with fluconazole compared to CRAG-negative persons with CD4\\<100 cells/mcL'}, {'measure': 'Survival Time', 'timeFrame': '6-month', 'description': 'Survival time among CRAG+ vs. CRAG negative persons with CD4\\<100 cells/mcL.'}, {'measure': 'Uptake of CRAG screening and preemptive treatment', 'timeFrame': 'baseline'}, {'measure': 'Time from CRAG+ test to receipt of fluconazole therapy', 'timeFrame': 'Days from CD4 testing'}, {'measure': 'All-cause discontinuation of fluconazole', 'timeFrame': '6-month', 'description': 'Number of participants with early discontinuation of fluconazole for any reason (e.g. non-compliance, adverse event)'}, {'measure': 'Percentage of participants with symptomatic cryptococcal meningitis', 'timeFrame': 'baseline'}, {'measure': 'Risk factors for symptomatic cryptococcal meningitis', 'timeFrame': 'baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cryptococcal meningitis', 'hiv', 'aids', 'implementation science', 'stepped wedge design', 'retention-in-care'], 'conditions': ['Cryptococcal Meningitis', 'Cryptococcus Neoformans', 'Cryptococcosis']}, 'referencesModule': {'references': [{'pmid': '22410867', 'type': 'BACKGROUND', 'citation': 'Rajasingham R, Meya DB, Boulware DR. Integrating cryptococcal antigen screening and pre-emptive treatment into routine HIV care. J Acquir Immune Defic Syndr. 2012 Apr 15;59(5):e85-91. doi: 10.1097/QAI.0b013e31824c837e.'}, {'pmid': '20597693', 'type': 'BACKGROUND', 'citation': 'Meya DB, Manabe YC, Castelnuovo B, Cook BA, Elbireer AM, Kambugu A, Kamya MR, Bohjanen PR, Boulware DR. Cost-effectiveness of serum cryptococcal antigen screening to prevent deaths among HIV-infected persons with a CD4+ cell count < or = 100 cells/microL who start HIV therapy in resource-limited settings. Clin Infect Dis. 2010 Aug 15;51(4):448-55. doi: 10.1086/655143.'}, {'pmid': '30399034', 'type': 'RESULT', 'citation': 'Meya DB, Kiragga AN, Nalintya E, Morawski BM, Rajasingham R, Park BJ, Mubiru A, Kaplan JE, Manabe YC, Boulware DR. Reflexive Laboratory-Based Cryptococcal Antigen Screening and Preemptive Fluconazole Therapy for Cryptococcal Antigenemia in HIV-Infected Individuals With CD4 <100 Cells/microL: A Stepped-Wedge, Cluster-Randomized Trial. J Acquir Immune Defic Syndr. 2019 Feb 1;80(2):182-189. doi: 10.1097/QAI.0000000000001894.'}], 'seeAlsoLinks': [{'url': 'http://www.idi-makerere.com', 'label': 'Infectious Disease Institute'}]}, 'descriptionModule': {'briefSummary': 'This will be a stepped wedge randomized trial design to evaluate the implementation of cryptococcal antigen (CRAG) screening and preemptive anti-fungal therapy of HIV-infected persons entering antiretroviral therapy (ART) outpatient treatment in Uganda. Those who are ART eligible with a CD4≤100 cells/mcL will have a serum/plasma CRAG performed by lateral flow assay. Those who are CRAG-positive and asymptomatic will be treated with high dose fluconazole. After 6 months survival with retention-in-care will be compared between those who are CRAG+ and CRAG negative'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 infection\n* CD4≤100 cells/mcL\n* Cryptococcal antigen (CRAG) positive\n* age \\>14 years\n\nExclusion Criteria:\n\n* Suspected Cryptococcal meningitis\n* Prior known history of cryptococcal meningitis\n* currently receiving HIV antiretroviral therapy\n* Allergy to any azole antifungal medication\n* Persons with known serious hepatic co-morbidities, transaminitis, or clinical jaundice who should not receive fluconazole in the opinion of the study investigator.\n* Current known pregnancy'}, 'identificationModule': {'nctId': 'NCT01535469', 'acronym': 'ORCAS', 'briefTitle': 'Operational Research for Cryptococcal Antigen Screening', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Operational Research for Cryptococcal Antigen Screening to Improve ART Survival', 'orgStudyIdInfo': {'id': 'HS1254'}, 'secondaryIdInfos': [{'id': 'U01GH000517', 'link': 'https://reporter.nih.gov/quickSearch/U01GH000517', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CrAg Screening and Fluconazole', 'description': 'Cryptococcal Antigen (CrAg) Screening with preemptive antifungal treatment per World Health Organization (WHO) guidelines. Randomized Stepped Wedge design of phased implementation.', 'interventionNames': ['Drug: Fluconazole']}], 'interventions': [{'name': 'Fluconazole', 'type': 'DRUG', 'otherNames': ['Diflucan'], 'description': 'Fluconazole 800mg orally daily for 2 weeks, then 400mg daily for 8 weeks', 'armGroupLabels': ['CrAg Screening and Fluconazole']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kampala', 'country': 'Uganda', 'facility': 'Infectious Disease Institute, Makerere University', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Kampala', 'country': 'Uganda', 'facility': 'Kampala Capital Council Authority Clinics', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}], 'overallOfficials': [{'name': 'David B Meya, MMed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Makerere University'}, {'name': 'Radha Rajasingham, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Infectious Disease Institute'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Upon request', 'ipdSharing': 'YES', 'description': 'After publication, data to be shared upon request to the Infectious Disease Institute Research Department as per the institutional data sharing policy.', 'accessCriteria': 'Upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'Infectious Diseases Institute, Uganda', 'class': 'OTHER'}, {'name': 'Makerere University', 'class': 'OTHER'}, {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}