A 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

NCT00002068

Collaborator

(none)

Locations

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: Fluconazole Drug: Amphotericin B	N/A

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A 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:

13 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Concurrent Medication:

Allowed:

Immunosuppressant therapy.
Antiviral therapy such as zidovudine.
Prophylaxis for Pneumocystis carinii pneumonia.

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.
Antiviral therapy such as zidovudine.
Prophylaxis for Pneumocystis carinii pneumonia.

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.

Concurrent Medication:

Excluded within 4 weeks of study entry:

Greater than 1 mg/kg/wk amphotericin B.
Coumadin-type anticoagulants.
Oral hypoglycemics.
Barbiturates.
Phenytoin.
Immunostimulants.
Investigational drugs or approved (licensed) drugs for investigational indications.

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 within 4 weeks of study entry:

Greater than 1 mg/kg/wk amphotericin B.
Coumadin-type anticoagulants.
Oral hypoglycemics.
Barbiturates.
Phenytoin.
Immunostimulants.
Investigational drugs or approved (licensed) drugs for investigational indications.

Prior Treatment:

Excluded:

Lymphocyte replacement.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Davies Med Ctr	San Francisco	California	United States	94114
2	Christiana Hosp / Med Ctr of Delaware	Wilmington	Delaware	United States	19899
3	Univ of South Florida	Tampa	Florida	United States	33612
4	Univ of Maryland / Inst of Human Virology	Baltimore	Maryland	United States	212011192
5	Henry Ford Hosp	Detroit	Michigan	United States	48202
6	Harlem AIDS Treatment Group / Harlem Hosp Ctr	New York	New York	United States	10037
7	Univ of Tennessee	Memphis	Tennessee	United States	38163
8	Saint Michael's Hosp	Toronto	Ontario	Canada