Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001017
Status:
COMPLETED
Last Update Posted:
2011-03-14
First Post:
1999-11-02
Brief Title:
Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients With AIDS
Sponsor:
Pfizer
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Comparison of Fluconazole UK-49858 and Amphotericin B for Maintenance Treatment of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome
Status:
COMPLETED
Status Verified Date:
2002-09
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 a new drug fluconazole with that of the usual therapy amphotericin B in the prevention of a relapse of cryptococcal meningitis CM in patients with AIDS who have been successfully treated for acute CM in the last 6 months
Cryptococcal meningitis is a life-threatening infectious complication of AIDS Because relapse after treatment occurs in over 50 percent of cases chronic maintenance therapy with intravenous IV amphotericin B is usually given However amphotericin B is not always effective has toxic effects and must be given by the intravenous route Fluconazole is an antifungal agent that can be given orally and has been shown to be effective against cryptococcal infections in animals and against acute CM in a few AIDS patients Also the side effects experienced by over 2000 patients or volunteers given fluconazole have seldom been severe enough to require withdrawal of the drug
Cryptococcal meningitis is a life-threatening infectious complication of AIDS Because relapse after treatment occurs in over 50 percent of cases chronic maintenance therapy with intravenous IV amphotericin B is usually given However amphotericin B is not always effective has toxic effects and must be given by the intravenous route Fluconazole is an antifungal agent that can be given orally and has been shown to be effective against cryptococcal infections in animals and against acute CM in a few AIDS patients Also the side effects experienced by over 2000 patients or volunteers given fluconazole have seldom been severe enough to require withdrawal of the drug
Detailed Description:
Cryptococcal meningitis is a life-threatening infectious complication of AIDS Because relapse after treatment occurs in over 50 percent of cases chronic maintenance therapy with intravenous IV amphotericin B is usually given However amphotericin B is not always effective has toxic effects and must be given by the intravenous route Fluconazole is an antifungal agent that can be given orally and has been shown to be effective against cryptococcal infections in animals and against acute CM in a few AIDS patients Also the side effects experienced by over 2000 patients or volunteers given fluconazole have seldom been severe enough to require withdrawal of the drug
Patients accepted in the trial are randomly assigned to fluconazole or amphotericin B Fluconazole is given orally once a day and amphotericin B is given intravenously once a week Dosages depend on body weight Medications may be given with amphotericin B to prevent or reduce discomfort from associated side effects Patients are treated for 12 months and may continue to receive antiviral therapy radiation therapy for mucocutaneous Kaposis sarcoma or preventive therapy for Pneumocystis carinii pneumonia PCP during the study
Patients accepted in the trial are randomly assigned to fluconazole or amphotericin B Fluconazole is given orally once a day and amphotericin B is given intravenously once a week Dosages depend on body weight Medications may be given with amphotericin B to prevent or reduce discomfort from associated side effects Patients are treated for 12 months and may continue to receive antiviral therapy radiation therapy for mucocutaneous Kaposis sarcoma or preventive therapy for Pneumocystis carinii pneumonia PCP during the study
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 |
|---|---|---|---|
| FDA 12E | None | None | None |
| 056-158 | None | None | None |