Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000639
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
1999-11-02
Brief Title:
A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis
Status:
COMPLETED
Status Verified Date:
2021-10
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 evaluate the effectiveness and safety of amphotericin B plus flucytosine 5-fluorocytosine compared to amphotericin B alone for a first episode of acute cryptococcal meningitis in AIDS patients and to compare the effectiveness and safety of fluconazole versus itraconazole
At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans More effective treatments than the standard therapy need to be explored
At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans More effective treatments than the standard therapy need to be explored
Detailed Description:
At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans More effective treatments than the standard therapy need to be explored
Patients are selected by a randomization process to take amphotericin B intravenously in the vein for 14 days and either placebo ineffective substance or flucytosine for 14 days Then patients are again selected by a randomization process to take either 1 fluconazole for a total of 8 weeks plus itraconazole placebo or 2 itraconazole for a total of 8 weeks plus fluconazole placebo
Patients are selected by a randomization process to take amphotericin B intravenously in the vein for 14 days and either placebo ineffective substance or flucytosine for 14 days Then patients are again selected by a randomization process to take either 1 fluconazole for a total of 8 weeks plus itraconazole placebo or 2 itraconazole for a total of 8 weeks plus fluconazole placebo
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 |
|---|---|---|---|
| 11134 | REGISTRY | DAIDS ES Registry Number | None |
| FDA 235A | None | None | None |
| MSG Study 17 | None | None | None |