drugset / Trial / NCT01715922
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
Phase 2/3
Unknown
41 enrolled
ANRS, Emerging Infectious Diseases
CHU Kamenge, BURUNDI · collabHospital Avicenne · collabHôpital Cocody · collabHôpital Necker-Enfants Malades · collabHôpital de Treichville · collabInstitut Pasteur · collabInstitut de Médecine et Epidémiologie Appliquée (IMEA) · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2012-05
- Primary completion
- 2015-09
- Completion
- 2016-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluconazole | Small molecule | 800 mg | Oral |
| Subject | Flucytosine | Small molecule | 100 mg/kg | Oral |