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Pilot Study of Oral Fluconazole for Acute Cryptococcal Meningitis
NCT00002076Phase 2
Key facts
- Status
- Completed
- Countries
- 1
- Sponsor
- Pfizer
- Modality
- Orthosteric Ligands
- Drugs
- fluconazole
- Conditions
- cryptococcal meningitis
01
Overview
Phase 2, open-label, single-arm trial of fluconazole in cryptococcal meningitis, sponsored by Pfizer. Primary endpoints: Clinical Success Rate at 10 weeks and Safety and Adverse Events. Status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Fluconazole
Oral Fluconazole monotherapy
03
Who it enrols
AIDS patients with acute cryptococcal meningitis, either newly diagnosed or relapsed. Patients must be able to take oral medication and have a life expectancy of > 2 weeks.
04
Endpoints
Primary
Clinical Success Rate
Safety and Adverse Events
Secondary
Cerebrospinal Fluid Culture Negativity
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