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 (Flucocrypto)

ANRS, Emerging Infectious Diseases

Status and phase: Unknown; Phase 3; Phase 2

Conditions: HIV; Cryptococcal Meningitis

Treatments: Procedure: lumbar punctures; Drug: Flucytosine; Drug: Fluconazole

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01715922

ANRS 12257 Flucocrypto

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

oral treatment

Other group

Description:

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)

Treatment:

Procedure: lumbar punctures

Drug: Flucytosine

Drug: Fluconazole