Overview

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:

Participant gender:

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

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