Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001039
Status:
COMPLETED
Last Update Posted:
2012-10-31
First Post:
1999-11-02
Brief Title:
Evaluation of Treatment for Mycobacterium Avium Complex MAC Infection in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
The Effect of Therapy on the Tissue Burden of Disseminated MAC Infection as Measured by Quantitative Bone Marrow Culture and Correlation With Quantitative Blood Culture in HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
2012-10
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 assess the feasibility of using culture and staining techniques to quantify tissue Mycobacterium avium Complex MAC burden in bone marrow To correlate and compare changes in MAC bone marrow burden with quantitative MAC blood culture results at baseline and after 4 and 8 weeks of treatment
MAC is easiest to detect in the blood although doctors generally believe that MAC in blood is just spill-over from infection of other parts of the body Traditionally studies of potential treatments for MAC focus only on MAC changes in the blood This study compares MAC changes in blood to those in bone marrow which is another tissue where MAC is often found
MAC is easiest to detect in the blood although doctors generally believe that MAC in blood is just spill-over from infection of other parts of the body Traditionally studies of potential treatments for MAC focus only on MAC changes in the blood This study compares MAC changes in blood to those in bone marrow which is another tissue where MAC is often found
Detailed Description:
MAC is easiest to detect in the blood although doctors generally believe that MAC in blood is just spill-over from infection of other parts of the body Traditionally studies of potential treatments for MAC focus only on MAC changes in the blood This study compares MAC changes in blood to those in bone marrow which is another tissue where MAC is often found
Patients receive both clarithromycin and ethambutol for 48 weeks those who become intolerant to the study drugs may receive suggested substitute drugs azithromycin and rifabutin Patients receive a bone marrow biopsy at baseline and at either 4 or 8 weeks Patients are evaluated at weeks 1 2 4 6 8 12 24 36 and 48
Patients receive both clarithromycin and ethambutol for 48 weeks those who become intolerant to the study drugs may receive suggested substitute drugs azithromycin and rifabutin Patients receive a bone marrow biopsy at baseline and at either 4 or 8 weeks Patients are evaluated at weeks 1 2 4 6 8 12 24 36 and 48
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 |
|---|---|---|---|
| 11739 | REGISTRY | DAIDS ES Registry ID | None |