HIV Infections Clinical Trial
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
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.
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.
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Masking: Open Label, Primary Purpose: Treatment
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