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Fluconazole vs Amphotericin B for Maintenance of Cryptococcal Meningitis in AIDS
NCT00001017Phase 3
Key facts
- Status
- Completed
- Primary completion
- Jul 1991
- Countries
- 1
- Sponsor
- Pfizer
- Modality
- Orthosteric Ligands
- Drugs
- fluconazole
- Conditions
- cryptococcal meningitis
01
Overview
Phase 3, randomised, open-label trial of fluconazole in cryptococcal meningitis (2 arms), sponsored by Pfizer. Primary endpoint: Rate of Relapse of Cryptococcal Meningitis at 12 months. Status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Fluconazole
Fluconazole oral daily
Amphotericin B
Amphotericin B IV weekly
03
Who it enrols
Patients with AIDS and documented HIV infection who have successfully completed primary therapy for acute cryptococcal meningitis (minimum 15 mg/kg Amphotericin B) within 6 weeks. Excludes patients with other forms of meningitis, allergy to azoles/amphotericin B, or recent use of systemic azoles.
04
Endpoints
Primary
Rate of Relapse of Cryptococcal Meningitis
Secondary
Safety and Side Effects
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