Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012467
Status:
COMPLETED
Last Update Posted:
2009-06-03
First Post:
2001-03-09
Brief Title:
Safety and Antifungal Activity of Recombinant Interferon-Gamma 1b rIFN-Gamma 1b Given With Standard Therapy in Patients With Cryptococcal Meningitis
Sponsor:
InterMune
Organization:
InterMune
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Dose-Ranging Phase II Study of the Safety and Antifungal Activity of Subcutaneous Recombinant Interferon-Gamma 1b rIFN-Gamma 1b in Conjunction With Standard Therapy in Patients With Acute Cryptococcal Meningitis
Status:
COMPLETED
Status Verified Date:
2009-05
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:
The purpose of this study is to examine the antifungal activity of recombinant interferon-gamma 1b rIFN-gamma 1b given with standard antifungal therapy
Detailed Description:
Patients are randomized into 1 of 3 parallel groups for a 3-arm 2-stage double-blind and dose-ranging study for 14 weeks In Stage 1 patients are hospitalized for 14 days of acute therapy Patients receive rIFN-gamma 1b or placebo sc 3 times per week intravenous IV AMB daily and with or without oral 5-FC every 6 hours Patients who have the ability to take oral medications who do not have any significant clinical deterioration during the previous 14 days and who meet the eligibility criteria can progress to Stage 2 In Stage 2 patients receive 84 days of consolidation therapy 56 days with study drug and 28 days of follow-up On an outpatient basis patients receive either placebo or 1 of 2 doses of rIFN-gamma 1b sc 3 times per week and oral fluconazole daily or oral itraconazole 2 times a day
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GIMY-001 | None | None | None |