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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001039 |
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.
Condition | Intervention | Phase |
Mycobacterium Avium-Intracellulare Infection HIV Infections |
Drug: Ethambutol hydrochloride Drug: Clarithromycin |
Phase II |
MedlinePlus related topics: | AIDS |
Drug Information available for: | Ethambutol hydrochloride Ethambutol Clarithromycin |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
Estimated Enrollment: | 24 |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
United States, Arizona | |||||
Univ of Arizona / Health Science Ctr | |||||
Tucson, Arizona, United States, 85724 | |||||
United States, Maryland | |||||
Univ of Maryland at Baltimore | |||||
Baltimore, Maryland, United States, 21201 | |||||
United States, New Jersey | |||||
UMDNJ - New Jersey Med School / Cooper Hosp | |||||
Camden, New Jersey, United States, 08103 | |||||
United States, New York | |||||
Albany Med College / Division of HIV Medicine A158 | |||||
Albany, New York, United States, 122083479 | |||||
SUNY / Health Sciences Ctr at Stony Brook | |||||
Stony Brook, New York, United States, 117948153 | |||||
United States, Oregon | |||||
Portland Veterans Adm Med Ctr / Rsch & Education Grp | |||||
Portland, Oregon, United States, 97210 | |||||
United States, Texas | |||||
Univ of Texas Southwestern Med Ctr of Dallas | |||||
Dallas, Texas, United States, 75235 | |||||
United States, Virginia | |||||
Richmond AIDS Consortium | |||||
Richmond, Virginia, United States, 23219 |
Study Chair: | Hafner R | |
Study Chair: | Drusano G |
Click here for more information about Clarithromycin 
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Study ID Numbers: | DATRI 007 |
First Received: | November 2, 1999 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00001039 |
Health Authority: | United States: Federal Government |
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