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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00002075

Collaborator

(none)

Location

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Meningitis, Cryptococcal HIV Infections	Drug: Flucytosine Drug: Fluconazole Drug: Amphotericin B	N/A

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

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.

Exclusion Criteria

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.
Moderate or severe liver disease.
Comatose.
Unlikely to survive more than 2 weeks.

Prior Medication:

Excluded:

Coumadin-type anticoagulants.
Oral hypoglycemics.
Barbiturates.
Phenytoin.
Immunostimulants.
Investigational drugs or approved (licensed) drugs for investigational indications.
Excluded within 4 weeks of study entry:
More than 1 mg/kg/wk amphotericin B.