Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients With AIDS
Meningitis, Cryptococcal, HIV Infections
About this trial
This is an interventional treatment trial for Meningitis, Cryptococcal focused on measuring AIDS-Related Opportunistic Infections, Meningitis, Injections, Intravenous, Cryptococcosis, Fluconazole, Administration, Oral, Acquired Immunodeficiency Syndrome, Amphotericin B
Eligibility Criteria
Inclusion Criteria HIV infection documented by antibody (ELISA on two occasions or ELISA with Western blot confirmation), p24 antigen testing, or recovery of HIV in culture. Prior Medication: Required: Minimum total dose of 15 mg/kg of amphotericin B (either alone or in combination with flucytosine) during primary therapy. End of primary therapy within 6 weeks of start of maintenance therapy. Allowed: Past or present antiviral therapy and prophylaxis for Pneumocystis carinii pneumonia (PCP). Pfizer must be notified if the patient is receiving ganciclovir at entry. Allowed with amphotericin B to treat or prevent side effects. Antipyretics. Hydrocortisone. Meperidine. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Clinical evidence of acute or chronic meningitis other than cryptococcosis. Allergy or intolerance of imidazoles, azoles, or amphotericin B. Unable to take oral medications reliably. Patients with the following are excluded: Clinical evidence of acute or chronic meningitis other than cryptococcosis. Allergy or intolerance of imidazoles, azoles, or amphotericin B. Prior Medication: Excluded for more than 7 days after initiation of primary therapy for cryptococcosis: Ketoconazole. Fluconazole. Itraconazole. Miconazole. Any other systemic imidazole or azole. Excluded: Intrathecal amphotericin B. Coumadin-type anticoagulants. Oral hypoglycemics. Barbiturates. Phenytoin. Immunostimulants. Investigational drug or approved (licensed) drugs for investigational indications. Prior Treatment: Excluded: Lymphocyte replacement.
Sites / Locations
- UCLA CARE Ctr
- Univ of Miami School of Medicine
- Indiana Univ Hosp
- Louisiana State Univ School of Medicine
- Tulane Univ School of Medicine
- Johns Hopkins Hosp
- Harvard (Massachusetts Gen Hosp)
- Beth Israel Deaconess - West Campus
- Jack Weiler Hosp / Bronx Municipal Hosp
- Montefiore Med Ctr / Bronx Municipal Hosp
- North Central Bronx Hosp / Bronx Municipal Hosp
- Bronx Veterans Administration / Mount Sinai Hosp
- SUNY / Erie County Med Ctr at Buffalo
- City Hosp Ctr at Elmhurst / Mount Sinai Hosp
- Beth Israel Med Ctr / Peter Krueger Clinic
- Bellevue Hosp / New York Univ Med Ctr
- Cornell Univ Med Ctr
- Mem Sloan - Kettering Cancer Ctr
- Saint Luke's - Roosevelt Hosp Ctr
- Mount Sinai Med Ctr
- Univ of Rochester Medical Center
- SUNY - Stony Brook
- Univ of North Carolina
- Duke Univ Med Ctr
- Holmes Hosp / Univ of Cincinnati Med Ctr
- Univ Hosp of Cleveland / Case Western Reserve Univ
- Ohio State Univ Hosp Clinic
- Julio Arroyo