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| ID | Type | Description | Link |
|---|---|---|---|
| CS 087250-999 |
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To compare the efficacy of clarithromycin/ethambutol with placebo or with rifabutin at two different doses in reducing colony-forming units (CFUs) by 2 or more logarithms in patients with Mycobacterium avium Complex bacteremia and maintaining this response until 16 weeks post-randomization. To assess survival and comparative tolerability among the three treatment regimens.
Patients are randomized to receive clarithromycin and ethambutol plus either placebo or rifabutin at one of two doses. Treatment continues indefinitely. AS PER AMENDMENT 04/19/94: Doses of rifabutin have been lowered.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethambutol hydrochloride | Drug | |||
| Clarithromycin | Drug | |||
| Rifabutin | Drug |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior condition are excluded:
History of hypersensitivity to rifabutin, rifampin, erythromycin, clarithromycin, azithromycin, or ethambutol.
Prior Medication:
Excluded within 7 days prior to study entry:
Excluded within 14 days prior to study entry:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McDowell Clinic | Phoenix | Arizona | 85006 | United States | ||
| Maricopa Med Research Foundation |
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| Phoenix |
| Arizona |
| 85008 |
| United States |
| Bay Harbor Hosp | Harbor City | California | 90710 | United States |
| Ctr for Special Immunology | Irvine | California | 92718 | United States |
| Combat Group | Los Angeles | California | 90028 | United States |
| Cedars Sinai Med Ctr | Los Angeles | California | 90048 | United States |
| Highland Gen Hosp / San Francisco Gen Hosp | Oakland | California | 946021018 | United States |
| HIV Research Group | San Diego | California | 92102 | United States |
| UCSD / Ctr for Special Immunology | San Diego | California | 92103 | United States |
| Saint Francis Mem Hosp | San Francisco | California | 94109 | United States |
| San Francisco Veterans Administration Med Ctr | San Francisco | California | 94121 | United States |
| Sunnyvale Med Clinic | Sunnyvale | California | 94086 | United States |
| George Washington Univ Med Ctr | Washington D.C. | District of Columbia | 20037 | United States |
| Veterans Administration Med Ctr | Washington D.C. | District of Columbia | 20422 | United States |
| Infectious Disease Consultants | Altamonte Springs | Florida | 32701 | United States |
| TheraFirst Med Ctrs Inc | Fort Lauderdale | Florida | 33308 | United States |
| Dr Frank Tornaka | Fort Lauderdale | Florida | 33316 | United States |
| Gary Richmond MD | Fort Lauderdale | Florida | 33316 | United States |
| Dr Nelson Zide | Hollywood | Florida | 33021 | United States |
| Ctr for Special Immunology | Miami Beach | Florida | 33140 | United States |
| Dr Barry Rodwick | Safety Harbor | Florida | 34695 | United States |
| Bay Area AIDS Consortium | Tampa | Florida | 33609 | United States |
| Infectious Disease Research Consortium of Georgia | Atlanta | Georgia | 30345 | United States |
| Dr Daniel Berger | Chicago | Illinois | 60657 | United States |
| Univ of Kansas School of Medicine | Wichita | Kansas | 67214 | United States |
| Tulane Univ Med School | New Orleans | Louisiana | 701122699 | United States |
| Dr Arnold Markowitz | Keego Harbor | Michigan | 48320 | United States |
| Univ of Nebraska Med Ctr / HIV Clinic | Omaha | Nebraska | 681985130 | United States |
| East Orange Veterans Administration Med Ctr | East Orange | New Jersey | 07018 | United States |
| North Jersey Community Research Initiative | Newark | New Jersey | 071032842 | United States |
| Long Island Jewish Med Ctr | New Hyde Park | New York | 11042 | United States |
| Chelsea Village Med Ctr / Saint Vincent's Hosp | New York | New York | 10014 | United States |
| Community Health Network | Rochester | New York | 14620 | United States |
| Nalle Clinic | Charlotte | North Carolina | 28207 | United States |
| Polyclinic Med Ctr | Harrisburg | Pennsylvania | 17110 | United States |
| Buckley Braffman Stern Med Associates | Philadelphia | Pennsylvania | 19107 | United States |
| Charleston Veterans Administration Med Ctr | Charleston | South Carolina | 294015799 | United States |
| Dr Alfred F Burnside Jr | Columbia | South Carolina | 29204 | United States |
| Central Texas Med Foundation | Austin | Texas | 78751 | United States |
| Houston Veterans Administration Med Ctr | Houston | Texas | 77030 | United States |
| Univ TX San Antonio Health Science Ctr | San Antonio | Texas | 78284 | United States |
| Infectious Disease Physicians Inc | Annandale | Virginia | 22203 | United States |
| Univ of Wisconsin School of Medicine | Madison | Wisconsin | 53792 | United States |
| Milwaukee County Med Complex | Milwaukee | Wisconsin | 53226 | 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 |
| D017828 | Rifabutin |
| ID | Term |
|---|---|
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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