Operational Research for Cryptococcal Antigen Screening
NCT ID: NCT01535469
Last Updated: 2020-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
3049 participants
INTERVENTIONAL
2012-07-01
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
SINGLE
Study Groups
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CrAg Screening and Fluconazole
Cryptococcal Antigen (CrAg) Screening with preemptive antifungal treatment per World Health Organization (WHO) guidelines. Randomized Stepped Wedge design of phased implementation.
Fluconazole
Fluconazole 800mg orally daily for 2 weeks, then 400mg daily for 8 weeks
Interventions
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Fluconazole
Fluconazole 800mg orally daily for 2 weeks, then 400mg daily for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* CD4≤100 cells/mcL
* Cryptococcal antigen (CRAG) positive
* age \>14 years
Exclusion Criteria
* Prior known history of cryptococcal meningitis
* currently receiving HIV antiretroviral therapy
* Allergy to any azole antifungal medication
* Persons with known serious hepatic co-morbidities, transaminitis, or clinical jaundice who should not receive fluconazole in the opinion of the study investigator.
* Current known pregnancy
14 Years
ALL
No
Sponsors
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Infectious Diseases Institute, Uganda
OTHER
Makerere University
OTHER
Centers for Disease Control and Prevention
FED
University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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David B Meya, MMed
Role: PRINCIPAL_INVESTIGATOR
Makerere University
Radha Rajasingham, MD
Role: STUDY_DIRECTOR
Infectious Disease Institute
Locations
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Infectious Disease Institute, Makerere University
Kampala, , Uganda
Kampala Capital Council Authority Clinics
Kampala, , Uganda
Countries
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References
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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.
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.
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.
Related Links
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Infectious Disease Institute
Other Identifiers
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HS1254
Identifier Type: -
Identifier Source: org_study_id
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