A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis
Meningitis, Cryptococcal, HIV Infections
About this trial
This is an interventional treatment trial for Meningitis, Cryptococcal focused on measuring AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Drug Therapy, Combination, Fluconazole, Flucytosine, Acquired Immunodeficiency Syndrome, Amphotericin B
Eligibility Criteria
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.
Sites / Locations
- Univ of Alabama at Birmingham
- Tucson Veterans Administration Med Ctr
- UCLA CARE Ctr
- Dr Shelly Gordon
- Dr Martin Mass
- Dr Paul Rothman
- Christiana Hosp / Med Ctr of Delaware
- George Washington Univ Med Ctr
- Univ of Miami School of Medicine
- Univ of South Florida
- Emory Univ School of Medicine
- Med College of Georgia
- DeKalb Gen Hosp
- Northwestern Univ Med School
- Louisiana State Univ School of Medicine
- Tulane Univ School of Medicine
- Dr Michael Bach
- Univ of Maryland / Inst of Human Virology
- Loch Raven Veterans Hosp
- New England Med Ctr
- Univ Hosp
- Ann Arbor Veterans Administration Med Ctr
- Harper Hosp
- Henry Ford Hosp
- Washington Univ School of Medicine
- Albany Med College / AIDS Treatment Ctr
- Montefiore Med Ctr / Bronx Municipal Hosp
- Bronx Veterans Administration / Mount Sinai Hosp
- Jewish Hosp Ctr Affiliation
- Chelsea Village Med Ctr
- Mem Sloan - Kettering Cancer Ctr
- Saint Luke's - Roosevelt Hosp Ctr
- Columbia Univ
- Harlem AIDS Treatment Group / Harlem Hosp Ctr
- Univ of North Carolina School of Medicine
- Cincinnati Veterans Adm Med Ctr / Univ Hosp
- Ohio State Univ Hosp
- Univ of Tennessee
- Dr Daniel Barbaro
- Univ TX Galveston Med Branch
- United States Air Force Med Ctr
- Univ TX San Antonio Health Science Ctr
- Richmond AIDS Consortium
- CHG-118 Group Health / Cooperative of Puget Sound
- Saint Michael's Hosp