Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001047
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease MAC Plus AIDS
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
An Open-Label Randomized Trial of Four Treatment Regimens for Patients With Disseminated Mycobacterium Avium Complex Disease and Acquired Immunodeficiency Syndrome 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 safety and efficacy of two doses of clarithromycin in combination with ethambutol and either rifabutin or clofazimine for the treatment of disseminated Mycobacterium avium Complex MAC disease in AIDS patients
Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide clarithromycin or azithromycin However the optimal treatment for disseminated MAC remains unknown
Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide clarithromycin or azithromycin However the optimal treatment for disseminated MAC remains unknown
Detailed Description:
Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide clarithromycin or azithromycin However the optimal treatment for disseminated MAC remains unknown
Patients are randomized to receive clarithromycin at one of two doses plus ethambutol and either rifabutin or clofazimine Patients are followed at 1 2 and 4 months and every 4 months thereafter for a minimum of 15 years to a common closing date
Patients are randomized to receive clarithromycin at one of two doses plus ethambutol and either rifabutin or clofazimine Patients are followed at 1 2 and 4 months and every 4 months thereafter for a minimum of 15 years to a common closing date
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 |
|---|---|---|---|
| 11577 | REGISTRY | DAIDS ES Registry Number | None |