A Phase 4 interventional study of Fluconazole in Cryptococcal Meningitis, Cryptococcus Neoformans and Cryptococcosis, sponsored by University of Minnesota. Completed at 2 sites in Uganda. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2020-06-04.
Sponsored by University of Minnesota · Phase 4, Interventional, and Prevention
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
54 studies on the registry are indexed under Meningitis, Cryptococcal; 6 are open to participants now.
This study's enrollment of 3,049 is above the median of 143 across 35 interventional studies indexed under Meningitis, Cryptococcal.
Browse Meningitis, Cryptococcal studies →University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cryptococcal Antigen (CrAg) Screening with preemptive antifungal treatment per World Health Organization (WHO) guidelines. Randomized Stepped Wedge design of phased implementation.
Drug: Fluconazole
Fluconazole 800mg orally daily for 2 weeks, then 400mg daily for 8 weeks
Also known as: Diflucan
Retention in care
1. before/after CRAG screening implementation (All persons) 2. CRAG positive persons treated with high-dose fluconazole as compared to 6-month survival of CRAG negative persons who are eligible for antiretroviral therapy.
Time frame: 6-month
Cryptococcal meningitis-free survival time
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
Time frame: 6-month
Survival Time
Survival time among CRAG+ vs. CRAG negative persons with CD4\<100 cells/mcL.
Time frame: 6-month
Uptake of CRAG screening and preemptive treatment
Time frame: baseline
Time from CRAG+ test to receipt of fluconazole therapy
Time frame: Days from CD4 testing
All-cause discontinuation of fluconazole
Number of participants with early discontinuation of fluconazole for any reason (e.g. non-compliance, adverse event)
Time frame: 6-month
Percentage of participants with symptomatic cryptococcal meningitis
Time frame: baseline
Risk factors for symptomatic cryptococcal meningitis
Time frame: baseline
Plan to share: Yes — After publication, data to be shared upon request to the Infectious Disease Institute Research Department as per the institutional data sharing policy.
Supporting information: Study protocol
Time frame: Upon request
Access criteria: Upon request
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fluconazole