HIV Infections Clinical Trial
Official title:
SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy
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.
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.
HIV-infected patients with a diagnosis of acute cryptococcal meningitis, previously
untreated or relapsed following a successfully treated acute episode, are enrolled in the
study. SCH 39304 is administered orally once daily for 3 days followed by a lower dose once
daily for 12 weeks. Patients who respond to primary therapy are randomized to receive SCH
39304 maintenance therapy at a higher dose once weekly or at the lower dose once daily for
up to 12 months under this protocol.
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Masking: Open Label, Primary Purpose: Treatment
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