A Phase 2/3 interventional study of Fluconazole and Flucytosine in Cryptococcal Meningitis and HIV, sponsored by ANRS, Emerging Infectious Diseases. Status unknown at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-12.
Sponsored by ANRS, Emerging Infectious Diseases · Phase 2/3, Interventional, and Treatment
The aim of the trial is to demonstrate that in a sub-Saharan African setting, the association of:
can decrease mortality rate below 35% at 10 weeks.
This is a non-randomized open label pilot study, with standardized management of cryptococcoses meningitis and follow-up in Burundi and Ivory Coast. A total of 41 patients will be enrolled.
54 studies on the registry are indexed under Meningitis, Cryptococcal; 6 are open to participants now.
This study's enrollment of 41 is below the median of 143 across 35 interventional studies indexed under Meningitis, Cryptococcal.
Browse Meningitis, Cryptococcal studies →ANRS, Emerging Infectious Diseases is the lead sponsor of 215 studies on the registry; 38 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Fluconazole and flucytosine Induction treatment for 2 weeks: Fluconazole (1600mg/j) + flucytosine (100 mg/kg/j) lumbar punctures to control intracranial pressure Consolidation treatment for 8 weeks: fluconazole (800 mg/j)
Drug: Fluconazole · Drug: Flucytosine · Procedure: lumbar punctures
Induction treatment for 2 weeks: Fluconazole (1600mg/j) Consolidation treatment for 8 weeks: fluconazole (800 mg/j)
Flucytosine (100 mg/kg/j) for 2 weeks
lumbar punctures to control intracranial pressure
Mortality rate
Time frame: 10 weeks
Mortality rate
Time frame: 14 days and 24 weeks
Percentage of patients with negative cerebrospinal fluid (CSF) cultures
Time frame: 14 days and 10 weeks
Number of relapses of cryptococcal throughout the monitoring period
Time frame: up to 24 weeks
Number of "Immune Reconstitution Inflammatory Syndrome" (IRIS) throughout the monitoring period
The IRIS diagnosis criteria will be those given in: Bicanic T, et al. Immune Reconstitution Inflammatory Syndrome in HIV-associated cryptococcal meningitis: a prospective study, J Acquir Immune Defic Syndr 2009; 51:130-134.
Time frame: up to 24 weeks
Number and severity of adverse events
Time frame: up to 24 weeks
Cerebrospinal fluid pressure evolution
Time frame: up to 24 weeks
Percentage of patients with undetectable viral load
Time frame: 24 weeks
CD4 count
Time frame: 24 weeks
Concentration of flucytosine in cerebrospinal fluid
Time frame: 28 days or 10 weeks
Sensitivity of cryptococcal antigen by strip method LFA (lateral-flow immunoassay)
on urines, plasma, CSF and whole blood fingerstick
Time frame: at study entry
CSF total volume discharged
Time frame: up to 24 weeks
Number of lumbar punctures performed
Time frame: up to 24 weeks
Concentration of fluconazole in plasma
Time frame: 28 days or 10 weeks
Concentration of fluconazole in cerebrospinal fluid
Time frame: 28 days or 10 weeks
Concentration of flucytosine in plasma
Time frame: 28 days or 10 weeks
MICs of fluconazole
MICs of fluconazole for cryptococcus strains, if CSF cultures ar positive at 28 days or 10 weeks or in case of relapse
Time frame: 28 days
This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Fluconazole · Flucytosine
ANRS, Emerging Infectious Diseases →