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

• Status: Unknown status
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Collaborators: CHU Kamenge, BURUNDI; Hôpital Cocody; Hôpital de Treichville; Hôpital Necker-Enfants Malades; Hospital Avicenne; Institut de Médecine et Epidémiologie Appliquée (IMEA); Institut Pasteur
• Treatments: Fluconazole; Flucytosine

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.