Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis

Completed · Not applicable

Conditions studied: Meningitis, Cryptococcal, HIV Infections

In brief

To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.

Key facts

Study ID

NCT00002075

Run by

Pfizer

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• Immunosuppressant therapy.
• Antiviral such as zidovudine.
• Radiation therapy for mucocutaneous Kaposi's sarcoma.
• Prophylaxis for Pneumocystis carinii pneumonia (PCP) including aerosol pentamidine.
• Concurrent Treatment:
• Allowed:
• Radiation therapy for mucocutaneous Kaposi's sarcoma.
• Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.
• No prior systemic antifungal therapy for cryptococcosis.
• Relapse after prior therapy.
• Success of prior therapy must have been documented by negative cerebrospinal fluid (CSF) culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into study.
• Prior Medication:
• Allowed:
• Immunosuppressant therapy.
• Antivirals such as zidovudine (AZT).
• Prophylaxis for Pneumocystis carinii pneumonia (PCP) including aerosol pentamidine.

You may not qualify if…

• Co-existing Condition:
• Patients with the following are excluded:
• Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
• History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.
• Moderate or severe liver disease.
• Comatose.
• Unlikely to survive more than 2 weeks.
• Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.
• Concurrent Medication:
• Excluded:
• Coumadin-type anticoagulants.
• Oral hypoglycemics.
• Barbiturates.
• Phenytoin.
• Immunostimulants.
• Investigational drugs or approved (licensed) drugs for investigational indications.
• Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.
• Excluded within 4 weeks of study entry:
• Received more than 1 mg/kg/wk amphotericin B.
• Concurrent Treatment:
• Excluded:
• Lymphocyte replacement.
• Patients with the following are excluded:
• Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
• History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.

Where it is running

• Dr Robert Larsen — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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