Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000708
Status:
COMPLETED
Last Update Posted:
2011-03-14
First Post:
1999-11-02
Brief Title:
Multi-center Comparison of Fluconazole UK-49858 and Amphotericin B as Treatment for 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:
Multi-center Comparison of Fluconazole UK-49858 and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
Status:
COMPLETED
Status Verified Date:
1991-07
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 compare the safety and effectiveness of fluconazole FCZ and amphotericin B AMB alone or in combination with flucytosine FLC as treatment for acute cryptococcal meningitis in patients who have not been treated previously or who have relapsed after a previous successful treatment
Cryptococcal meningitis is an important cause of disease and death among patients with AIDS Usually AMB is given either alone or with FLC to patients with this infection but these treatments are not always effective and both have toxic effects Animal studies and preliminary studies in humans show that FCZ is active in cryptococcal meningitis and suggest that it may be less toxic than either AMB or FLC
Cryptococcal meningitis is an important cause of disease and death among patients with AIDS Usually AMB is given either alone or with FLC to patients with this infection but these treatments are not always effective and both have toxic effects Animal studies and preliminary studies in humans show that FCZ is active in cryptococcal meningitis and suggest that it may be less toxic than either AMB or FLC
Detailed Description:
Cryptococcal meningitis is an important cause of disease and death among patients with AIDS Usually AMB is given either alone or with FLC to patients with this infection but these treatments are not always effective and both have toxic effects Animal studies and preliminary studies in humans show that FCZ is active in cryptococcal meningitis and suggest that it may be less toxic than either AMB or FLC
Patients accepted into the study are randomly assigned to FCZ or AMB Patients assigned to FCZ take FCZ by mouth daily for 10 weeks Patients assigned to AMB are given intravenous injections of AMB daily for 6-10 weeks Non-AIDS patients assigned to AMB also take FLC by mouth daily The use of FLC in patients with AIDS is decided on an individual basis Patients with AIDS who respond satisfactorily to FCZ receive maintenance therapy to prevent relapse for an additional 12 months Patients with AIDS who respond to AMB may qualify for another Pfizer Central Research protocol Patients without AIDS who respond to therapy are observed for 6 months for relapse During therapy samples of blood and cerebrospinal fluid by lumbar puncture are taken periodically in order to evaluate the effectiveness of the drug treatments and to identify possible toxic effects
Patients accepted into the study are randomly assigned to FCZ or AMB Patients assigned to FCZ take FCZ by mouth daily for 10 weeks Patients assigned to AMB are given intravenous injections of AMB daily for 6-10 weeks Non-AIDS patients assigned to AMB also take FLC by mouth daily The use of FLC in patients with AIDS is decided on an individual basis Patients with AIDS who respond satisfactorily to FCZ receive maintenance therapy to prevent relapse for an additional 12 months Patients with AIDS who respond to AMB may qualify for another Pfizer Central Research protocol Patients without AIDS who respond to therapy are observed for 6 months for relapse During therapy samples of blood and cerebrospinal fluid by lumbar puncture are taken periodically in order to evaluate the effectiveness of the drug treatments and to identify possible toxic effects
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 |
|---|---|---|---|
| Investigator 556 | None | None | None |
| Protocol 159 | None | None | None |
| Project 056 | None | None | None |