Trial | NCT01715922  Report issue

Title

Study Evaluating Efficiency and Tolerance of High-dose Fluconazole Associated With Flucytosine as Induction Therapy for Cryptococcal Meningitis Associated With HIV in Sub-saharan Africa
Prospective Pilot Study to Evaluate a Standardized Management of Cryptococcal Meningitis in Patients Infected With HIV in Sub-Saharan Africa Involving an Initial Combination Therapy With Fluconazole and Flucytosine in High Doses, Complemented by Repeat Lumbar Punctures

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    41
The aim of the trial is to demonstrate that in a sub-Saharan African setting, the association of:

Oral treatment : high dose of fluconazole (1600mg/d) associated with flucytosine (100 mg/kg/j) as induction therapy
lumbar punctures to control intracranial pressure

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.
Study Started
May 31
2012
Primary Completion
Sep 30
2015
Study Completion
Sep 30
2016
Anticipated
Last Update
Jul 12
2016
Estimate

Drug Fluconazole

Induction treatment for 2 weeks: Fluconazole (1600mg/j) Consolidation treatment for 8 weeks: fluconazole (800 mg/j)

Drug Flucytosine

Flucytosine (100 mg/kg/j) for 2 weeks

Procedure lumbar punctures

lumbar punctures to control intracranial pressure

oral treatment Other

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)

Criteria 

Inclusion Criteria:

> 18 years
HIV Infection
First episode of cryptococcal meningitis on basis CSF India ink and/or CSF cryptococcal antigen.
Glasgow > 9 after lumbar punctures
Absence of peripheral focal deficit in the limbs
informed consent signed

Exclusion Criteria:

Hemoglobin <7.5 g / dl;
neutrophils count <500/mm3;
Platelets count <50 000/mm3;
transaminases > 5 times upper limit of normal;
Troubles with severe mental alertness Glasgow <9 after the initial lumbar puncture;
focal neurological deficit in the limbs;
Pregnancy or lactation on going;
Ongoing systemic antifungal treatment;
History of cryptococcal meningitis;
Ongoing rifampicin and ritonavir treatment;
Subject participating in another study with a risk of mutual interference on the interpretation of results.
No Results Posted