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

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.

Conditions

• Cryptococcal Meningitis
• HIV

Interventions

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

Sponsors & Collaborators

• CHU Kamenge, BURUNDI

  collaborator UNKNOWN

• Hospital Avicenne

  collaborator OTHER

• Institut Pasteur

  collaborator INDUSTRY

• Hôpital Necker-Enfants Malades

  collaborator OTHER

• Institut de Médecine et Epidémiologie Appliquée (IMEA)

  collaborator UNKNOWN

• Hôpital de Treichville

  collaborator UNKNOWN

• Hôpital Cocody

  collaborator UNKNOWN

• ANRS, Emerging Infectious Diseases

  lead OTHER_GOV

Principal Investigators

• Olivier Bouchaud, PhD · Hopital Avicenne, Service des maladies infectieuses, Paris, france

• Théodore Niyangobo, PhD · CHU Kamenge, Bujumbura, Burundi

• Amélie Chabrol, MD · Hopital Avicenne, Service des maladies infectieuses, Paris, france

• Kakou AKA, Professor · CHU Triechville

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-05-31

Primary Completion

2015-09-30

Completion

2016-09-30

Countries

• Burundi
• Côte d’Ivoire

Study Locations