Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002113
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis
Sponsor:
Pfizer
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis
Status:
COMPLETED
Status Verified Date:
1996-04
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 and estimate the safety and efficacy of the combination of fluconazole and flucytosine as treatment for acute cryptococcal meningitis in patients with AIDS
Fluconazole and flucytosine have different mechanisms of action Since fluconazole has not been associated with hematologic suppression and does not produce renal impairment that can result in higher serum flucytosine levels this combination may be better tolerated than is amphotericin B plus flucytosine
Fluconazole and flucytosine have different mechanisms of action Since fluconazole has not been associated with hematologic suppression and does not produce renal impairment that can result in higher serum flucytosine levels this combination may be better tolerated than is amphotericin B plus flucytosine
Detailed Description:
Fluconazole and flucytosine have different mechanisms of action Since fluconazole has not been associated with hematologic suppression and does not produce renal impairment that can result in higher serum flucytosine levels this combination may be better tolerated than is amphotericin B plus flucytosine
Patients in each cohort receive a lower dose of fluconazole alone or in combination with flucytosine or a higher dose of fluconazole alone Doses in subsequent cohorts are escalated if safety data in the previous cohort is satisfactory Patients are evaluated weekly for the first 4 weeks and every 2 weeks thereafter Therapy continues until 8 weeks after the CSF becomes culture negative up to a maximum of 26 weeks
Patients in each cohort receive a lower dose of fluconazole alone or in combination with flucytosine or a higher dose of fluconazole alone Doses in subsequent cohorts are escalated if safety data in the previous cohort is satisfactory Patients are evaluated weekly for the first 4 weeks and every 2 weeks thereafter Therapy continues until 8 weeks after the CSF becomes culture negative up to a maximum of 26 weeks
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 |
|---|---|---|---|
| R-0202 | None | None | None |