To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in
combination with flucytosine, as treatment for acute cryptococcal meningitis.
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.
- 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:
- Greater 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:
- Greater than 1 mg/kg/wk amphotericin B.
Prior Treatment:
Excluded:
- Lymphocyte replacement.
Univ of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Tucson Veterans Administration Med Ctr, Tucson, Arizona 85724, United States
UCLA CARE Ctr, Los Angeles, California 90095, United States
Dr Paul Rothman, Sherman Oaks, California 91403, United States
Dr Martin Mass, San Francisco, California 94120, United States
Dr Shelly Gordon, San Francisco, California 94115, United States
Christiana Hosp / Med Ctr of Delaware, Wilmington, Delaware 19899, United States
George Washington Univ Med Ctr, Washington, District of Columbia 20037, United States
Univ of Miami School of Medicine, Miami, Florida 331361013, United States
Univ of South Florida, Tampa, Florida 33612, United States
DeKalb Gen Hosp, Decatur, Georgia 30033, United States
Med College of Georgia, Augusta, Georgia 30912, United States
Emory Univ School of Medicine, Atlanta, Georgia 30303, United States
Northwestern Univ Med School, Chicago, Illinois 60611, United States
Tulane Univ School of Medicine, New Orleans, Louisiana 70112, United States
Louisiana State Univ School of Medicine, New Orleans, Louisiana 70112, United States
Dr Michael Bach, Portland, Maine 04102, United States
Loch Raven Veterans Hosp, Baltimore, Maryland 21218, United States
Univ of Maryland / Inst of Human Virology, Baltimore, Maryland 212011192, United States
New England Med Ctr, Boston, Massachusetts 02111, United States
Univ Hosp, Boston, Massachusetts 02118, United States
Henry Ford Hosp, Detroit, Michigan 48202, United States
Harper Hosp, Detroit, Michigan 48201, United States
Ann Arbor Veterans Administration Med Ctr, Ann Arbor, Michigan 48105, United States
Washington Univ School of Medicine, St. Louis, Missouri 63108, United States
Saint Luke's - Roosevelt Hosp Ctr, New York, New York 10025, United States
Montefiore Med Ctr / Bronx Municipal Hosp, Bronx, New York 10467, United States
Bronx Veterans Administration / Mount Sinai Hosp, Bronx, New York 10468, United States
Columbia Univ, New York, New York 10032, United States
Jewish Hosp Ctr Affiliation, Jamaica, New York 11432, United States
Chelsea Village Med Ctr, New York, New York 10014, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr, New York, New York 10037, United States
Albany Med College / AIDS Treatment Ctr, Albany, New York 12203, United States
Mem Sloan - Kettering Cancer Ctr, New York, New York 10021, United States
Univ of North Carolina School of Medicine, Chapel Hill, North Carolina 275997215, United States
Cincinnati Veterans Adm Med Ctr / Univ Hosp, Cincinnati, Ohio 452670405, United States
Ohio State Univ Hosp, Columbus, Ohio 43210, United States
Saint Michael's Hosp, Toronto, Ontario, Canada
Univ of Tennessee, Memphis, Tennessee 38163, United States
United States Air Force Med Ctr, Lackland Air Force Base, Texas 782365300, United States
Dr Daniel Barbaro, Dallas, Texas 75235, United States
Univ TX San Antonio Health Science Ctr, San Antonio, Texas 78284, United States
Univ TX Galveston Med Branch, Galveston, Texas 77550, United States
Richmond AIDS Consortium, Richmond, Virginia 23219, United States
CHG-118 Group Health / Cooperative of Puget Sound, Seattle, Washington 98112, United States
