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

Prospective Pilot Study to Evaluate a Standardized Management of Cryptococcal Meningitis in Patients Infected With HIV in Sub-Saharan Africa Involving an Initial Combination Therapy With Fluconazole and Flucytosine in High Doses, Complemented by Repeat Lumbar Punctures

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-09-01
• Completion: 2016-09-01
• First posted: 2012-10-29
• Last updated: 2016-07-12

Locations

7 sites across 2 countries: Burundi, Côte d’Ivoire