SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy
Meningitis, Cryptococcal, HIV Infections
About this trial
This is an interventional treatment trial for Meningitis, Cryptococcal focused on measuring Sch 39304, AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Drug Evaluation, Antifungal Agents, Acquired Immunodeficiency Syndrome
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Currently approved antiviral therapy. Maintenance therapy for cytomegalovirus retinitis or toxoplasmosis. Rifampin. Isoniazid. Dilantin or barbiturates if investigator agrees to rigorously monitor anticonvulsant drug levels. Coumarin-type anticoagulants if investigator agrees to rigorously monitor prothrombin time. Prophylactic treatment for Pneumocystis carinii pneumonia (PCP). Concurrent Treatment: Allowed: Local radiotherapy for mucocutaneous Kaposi's sarcoma. Prior Medication: Allowed: Amphotericin B, up to 1 mg/kg, during the previous 7 days. Patients must be HIV positive by 2 methodologies and have either primary cryptococcal meningitis with no prior anti-cryptococcal therapy or relapsed disease after prior therapy. Prior therapy for cryptococcal meningitis is limited to approved drugs. Written informed consent either from patient or patient's parent or legal guardian is required. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: History of hypersensitivity to imidazole or azole compounds. Central nervous system disease. Acute opportunistic infection. Underlying conditions that in the opinion of the investigator could preclude assessment of response. Concurrent Medication: Excluded: Systemic antifungal drugs other than study drug. Any investigational drug other than treatment IND drugs. Oral hypoglycemic agents. Oral contraceptives. Cytotoxic chemotherapy. Patients with the following are excluded: Unable to take oral medications. Concurrent central nervous system disease which in opinion of investigator would interfere with assessment of response. Concurrent acute opportunistic infection requiring therapy (patients who develop an acute opportunistic infection after initiation of study medication may remain on study medication). Prior Medication: Excluded within 7 days of study entry: Amphotericin B, > 1 mg/kg.
Sites / Locations
- Birmingham Veterans Administration Med Ctr
- Dr Robert Larsen
- Univ of California / San Diego Treatment Ctr
- San Francisco AIDS Clinic / San Francisco Gen Hosp
- George Washington Univ Med Ctr
- Emory Univ School of Medicine
- Med College of Georgia
- Rush Presbyterian - Saint Luke's Med Ctr
- Indiana Univ Hosp
- Tulane Univ School of Medicine
- Univ Hosp
- St Louis Regional Hosp / St Louis Regional Med Ctr
- Bronx Veterans Administration / Mount Sinai Hosp
- Erie County Med Ctr
- Beth Israel Med Ctr
- Mount Sinai Med Ctr
- Univ of Rochester Medical Center
- 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 Med Ctr
- Buckley Braffman Stern Med Associates
- Julio Arroyo
- Houston Veterans Administration Med Ctr
- Univ TX Health Science Ctr
- Audie L Murphy Veterans Administration Hosp
- Richmond AIDS Consortium