Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002101
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS A ClarithromycinEthambutol Regimen Containing Rifabutin 450 Mg or Rifabutin 300 Mg or Placebo
Sponsor:
Pharmacia
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS A ClarithromycinEthambutol Regimen Containing Rifabutin 450 Mg or Rifabutin 300 Mg or Placebo
Status:
COMPLETED
Status Verified Date:
1999-06
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 efficacy of clarithromycinethambutol with placebo or with rifabutin at two different doses in reducing colony-forming units CFUs by 2 or more logarithms in patients with Mycobacterium avium Complex bacteremia and maintaining this response until 16 weeks post-randomization To assess survival and comparative tolerability among the three treatment regimens
Detailed Description:
Patients are randomized to receive clarithromycin and ethambutol plus either placebo or rifabutin at one of two doses Treatment continues indefinitely AS PER AMENDMENT 041994 Doses of rifabutin have been lowered
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 |
|---|---|---|---|
| CS 087250-999 | None | None | None |