Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000677
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy
Status:
COMPLETED
Status Verified Date:
1994-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C89-258 | None | None | None |