Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001058
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex MAC Disease in Patients With AIDS
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase IIIII Prospective Multicenter Randomized Controlled Trial Comparing the Safety and Efficacy of Three Clarithromycin-Containing Combination Drug Regimens for the Treatment of Disseminated Mycobacterium Avium Complex MAC Disease in Persons With AIDS
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 compare the efficacy and safety of clarithromycin combined with rifabutin ethambutol or both in the treatment of disseminated Mycobacterium avium Complex MAC disease in persons with AIDS including individuals who have or have not received prior MAC prophylaxis
It is believed that effective therapy for MAC disease in patients with AIDS requires combinations of two or more antimycobacterial agents in order to overcome drug resistance and the unfavorable influence of the profound immunosuppression associated with AIDS Data suggest that clarithromycin may have substantial activity in two- or three-drug combination regimens with clofazimine rifamycin derivatives ethambutol or the 4-quinolones
It is believed that effective therapy for MAC disease in patients with AIDS requires combinations of two or more antimycobacterial agents in order to overcome drug resistance and the unfavorable influence of the profound immunosuppression associated with AIDS Data suggest that clarithromycin may have substantial activity in two- or three-drug combination regimens with clofazimine rifamycin derivatives ethambutol or the 4-quinolones
Detailed Description:
It is believed that effective therapy for MAC disease in patients with AIDS requires combinations of two or more antimycobacterial agents in order to overcome drug resistance and the unfavorable influence of the profound immunosuppression associated with AIDS Data suggest that clarithromycin may have substantial activity in two- or three-drug combination regimens with clofazimine rifamycin derivatives ethambutol or the 4-quinolones
Patients are randomized to one of three treatment arms containing clarithromycin in combination with ethambutol rifabutin or both Clarithromycin alone is taken on days 1 through 3 to determine tolerance and rifabutin andor ethambutol is added on day 3 AS PER AMENDMENT 7297 Patients may elect to add ritonavir or indinavir to their treatment regimen Treatment continues daily for 48 weeks In the absence of a dose-limiting toxicity those patients who are determined to be complete or partial responders continue on the regimen to which they were originally assigned Patients who have failed or relapsed on originally assigned MAC therapy must have their therapy amended to receive clarithromycin and at least two other drugs not included in their originally assigned regimen Patients are followed twice in the first week then every 2 weeks for the first 2 months then monthly for the next 4 months and then every 2 months thereafter until the end of 12 months PER AMENDMENT 101096 NOTE Any patient who develops a toxicity to rifabutin or ethambutol after week 12 or thereafter will be offered the option of being registered to a salvage regimen of 2 new drugs not previously received plus clarithromycin to continue for the study duration
Patients are randomized to one of three treatment arms containing clarithromycin in combination with ethambutol rifabutin or both Clarithromycin alone is taken on days 1 through 3 to determine tolerance and rifabutin andor ethambutol is added on day 3 AS PER AMENDMENT 7297 Patients may elect to add ritonavir or indinavir to their treatment regimen Treatment continues daily for 48 weeks In the absence of a dose-limiting toxicity those patients who are determined to be complete or partial responders continue on the regimen to which they were originally assigned Patients who have failed or relapsed on originally assigned MAC therapy must have their therapy amended to receive clarithromycin and at least two other drugs not included in their originally assigned regimen Patients are followed twice in the first week then every 2 weeks for the first 2 months then monthly for the next 4 months and then every 2 months thereafter until the end of 12 months PER AMENDMENT 101096 NOTE Any patient who develops a toxicity to rifabutin or ethambutol after week 12 or thereafter will be offered the option of being registered to a salvage regimen of 2 new drugs not previously received plus clarithromycin to continue for the study duration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11200 | REGISTRY | DAIDS-ES | None |