SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
To assess the safety and effectiveness of SCH 39304 as primary treatment of acute
cryptococcal meningitis in HIV-infected patients. Safety and effectiveness of maintenance
therapy following successful treatment of acute disease are also evaluated.
Cryptococcal meningitis is a significant cause of illness and death in HIV-infected patients.
Intravenous amphotericin B is effective for acute disease but relapse occurs in the majority
of patients. Maintenance therapy is recommended but must be balanced against the multiple
toxicities of the drugs used and the problems associated with the weekly administration of
intravenous therapy. Treatments that are equally or more effective and less toxic than
traditional methods are needed, especially oral therapy. SCH 39304 is an orally active
antifungal drug that in animal studies is active against a wide range of systemic fungal
infections including infections due to Cryptococcus. Features of SCH 39304 suggest that it
might be of value in the treatment of cryptococcal meningitis.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)