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| Sponsor: | Pharmacia |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002101 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Mycobacterium Avium-Intracellulare Infection HIV Infections |
Drug: Ethambutol hydrochloride Drug: Clarithromycin Drug: Rifabutin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Efficacy Study |
| Official Title: | A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 Mg) or Rifabutin (300 Mg) or Placebo |
Eligibility| 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
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:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| McDowell Clinic | |
| Phoenix, Arizona, United States, 85006 | |
| Maricopa Med Research Foundation | |
| Phoenix, Arizona, United States, 85008 | |
| United States, California | |
| San Francisco Veterans Administration Med Ctr | |
| San Francisco, California, United States, 94121 | |
| Ctr for Special Immunology | |
| Irvine, California, United States, 92718 | |
| HIV Research Group | |
| San Diego, California, United States, 92102 | |
| UCSD / Ctr for Special Immunology | |
| San Diego, California, United States, 92103 | |
| Combat Group | |
| Los Angeles, California, United States, 90028 | |
| Bay Harbor Hosp | |
| Harbor City, California, United States, 90710 | |
| Saint Francis Mem Hosp | |
| San Francisco, California, United States, 94109 | |
| Sunnyvale Med Clinic | |
| Sunnyvale, California, United States, 94086 | |
| Highland Gen Hosp / San Francisco Gen Hosp | |
| Oakland, California, United States, 946021018 | |
| Cedars Sinai Med Ctr | |
| Los Angeles, California, United States, 90048 | |
| United States, District of Columbia | |
| Veterans Administration Med Ctr | |
| Washington, District of Columbia, United States, 20422 | |
| George Washington Univ Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| TheraFirst Med Ctrs Inc | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Dr Nelson Zide | |
| Hollywood, Florida, United States, 33021 | |
| Bay Area AIDS Consortium | |
| Tampa, Florida, United States, 33609 | |
| Dr Frank Tornaka | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Ctr for Special Immunology | |
| Miami Beach, Florida, United States, 33140 | |
| Gary Richmond MD | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Dr Barry Rodwick | |
| Safety Harbor, Florida, United States, 34695 | |
| Infectious Disease Consultants | |
| Altamonte Springs, Florida, United States, 32701 | |
| United States, Georgia | |
| Infectious Disease Research Consortium of Georgia | |
| Atlanta, Georgia, United States, 30345 | |
| United States, Illinois | |
| Dr Daniel Berger | |
| Chicago, Illinois, United States, 60657 | |
| United States, Kansas | |
| Univ of Kansas School of Medicine | |
| Wichita, Kansas, United States, 67214 | |
| United States, Louisiana | |
| Tulane Univ Med School | |
| New Orleans, Louisiana, United States, 701122699 | |
| United States, Michigan | |
| Dr Arnold Markowitz | |
| Keego Harbor, Michigan, United States, 48320 | |
| United States, Nebraska | |
| Univ of Nebraska Med Ctr / HIV Clinic | |
| Omaha, Nebraska, United States, 681985130 | |
| United States, New Jersey | |
| East Orange Veterans Administration Med Ctr | |
| East Orange, New Jersey, United States, 07018 | |
| North Jersey Community Research Initiative | |
| Newark, New Jersey, United States, 071032842 | |
| United States, New York | |
| Long Island Jewish Med Ctr | |
| New Hyde Park, New York, United States, 11042 | |
| Chelsea Village Med Ctr / Saint Vincent's Hosp | |
| New York, New York, United States, 10014 | |
| Community Health Network | |
| Rochester, New York, United States, 14620 | |
| United States, North Carolina | |
| Nalle Clinic | |
| Charlotte, North Carolina, United States, 28207 | |
| United States, Pennsylvania | |
| Buckley Braffman Stern Med Associates | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Polyclinic Med Ctr | |
| Harrisburg, Pennsylvania, United States, 17110 | |
| United States, South Carolina | |
| Dr Alfred F Burnside Jr | |
| Columbia, South Carolina, United States, 29204 | |
| Charleston Veterans Administration Med Ctr | |
| Charleston, South Carolina, United States, 294015799 | |
| United States, Texas | |
| Univ TX San Antonio Health Science Ctr | |
| San Antonio, Texas, United States, 78284 | |
| Houston Veterans Administration Med Ctr | |
| Houston, Texas, United States, 77030 | |
| Central Texas Med Foundation | |
| Austin, Texas, United States, 78751 | |
| United States, Virginia | |
| Infectious Disease Physicians Inc | |
| Annandale, Virginia, United States, 22203 | |
| United States, Wisconsin | |
| Univ of Wisconsin School of Medicine | |
| Madison, Wisconsin, United States, 53792 | |
| Milwaukee County Med Complex | |
| Milwaukee, Wisconsin, United States, 53226 | |
More Information
| Study ID Numbers: | 048D, CS 087250-999 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002101 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Rifabutin Mycobacterium avium-intracellulare Infection Drug Therapy, Combination |
Ethambutol Acquired Immunodeficiency Syndrome Clarithromycin |
|
Bacterial Infections Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Rifabutin Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Anti-Bacterial Agents Clarithromycin Gram-Positive Bacterial Infections Pathologic Processes Therapeutic Uses Retroviridae Infections Systemic Inflammatory Response Syndrome |
RNA Virus Infections Immune System Diseases Acquired Immunodeficiency Syndrome Bacteremia Enzyme Inhibitors Pharmacologic Actions Immunologic Deficiency Syndromes Actinomycetales Infections Mycobacterium Infections, Atypical Antibiotics, Antitubercular Mycobacterium avium-intracellulare Infection Inflammation Virus Diseases Protein Synthesis Inhibitors Sepsis |
