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

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2016-09-30

Brief Summary

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

1. Oral treatment : high dose of fluconazole (1600mg/d) associated with flucytosine (100 mg/kg/j) as induction therapy
2. 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.

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Detailed Description

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Conditions

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Cryptococcal Meningitis HIV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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oral treatment

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)

Group Type OTHER

Fluconazole

Intervention Type DRUG

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

Flucytosine

Intervention Type DRUG

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

lumbar punctures

Intervention Type PROCEDURE

lumbar punctures to control intracranial pressure

Interventions

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Fluconazole

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

Intervention Type DRUG

Flucytosine

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

Intervention Type DRUG

lumbar punctures

lumbar punctures to control intracranial pressure

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No