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| ID | Type | Description | Link |
|---|---|---|---|
| 11739 | Registry Identifier | DAIDS ES Registry ID |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethambutol hydrochloride | Drug | |||
| Clarithromycin | Drug |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
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| Name | Affiliation | Role |
|---|---|---|
| Hafner R | Study Chair | |
| Drusano G | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ of Arizona / Health Science Ctr | Tucson | Arizona | 85724 | United States | ||
| Univ of Maryland at Baltimore |
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| Baltimore |
| Maryland |
| 21201 |
| United States |
| UMDNJ - New Jersey Med School / Cooper Hosp | Camden | New Jersey | 08103 | United States |
| Albany Med College / Division of HIV Medicine A158 | Albany | New York | 122083479 | United States |
| SUNY / Health Sciences Ctr at Stony Brook | Stony Brook | New York | 117948153 | United States |
| Portland Veterans Adm Med Ctr / Rsch & Education Grp | Portland | Oregon | 97210 | United States |
| Univ of Texas Southwestern Med Ctr of Dallas | Dallas | Texas | 75235 | United States |
| Richmond AIDS Consortium | Richmond | Virginia | 23219 | United States |
| ID | Term |
|---|---|
| D015270 | Mycobacterium avium-intracellulare Infection |
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D009165 | Mycobacterium Infections, Nontuberculous |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| D004977 | Ethambutol |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
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