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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.
Age
13 - No limit years
Sex
ALL
Healthy Volunteers
No
Univ of Arizona / Health Science Ctr
Tucson, Arizona, United States
Univ of Maryland at Baltimore
Baltimore, Maryland, United States
UMDNJ - New Jersey Med School / Cooper Hosp
Camden, New Jersey, United States
Albany Med College / Division of HIV Medicine A158
Albany, New York, United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States
Richmond AIDS Consortium
Richmond, Virginia, United States
Completion Date
June 1, 2002
Last Updated
October 31, 2012
24
Estimated participants
Ethambutol hydrochloride
DRUG
Clarithromycin
DRUG
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NCT06694805
NCT04142047
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07428330