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

Condition(s) targeted: Mycobacterium Avium-Intracellulare Infection; HIV Infections

Intervention: Ethambutol hydrochloride (Drug); Clarithromycin (Drug); Rifabutin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pharmacia

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.

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

Study design: Treatment, Double-Blind, Efficacy Study

Detailed description: 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.

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria

Concurrent Medication:

Allowed:

- Isoniazid for TB prophylaxis ONLY.

Patients must have:

- HIV infection.

- MAC infection.

- Life expectancy of at least 16 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Perceived unreliability or unavailability for frequent monitoring.

Concurrent Medication:

Excluded:

- Antimycobacterial drugs other than the study drugs.

- Carbamazepine.

- Terfenadine.

- Theophylline.

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:

- Rifabutin.

- Rifampin.

- Ethionamide.

- Cycloserine.

- Clofazimine.

- Ethambutol.

- Amikacin.

- Ciprofloxacin.

- Ofloxacin.

- Sparfloxacin.

- Azithromycin.

- Clarithromycin.

- Pyrazinamide.

Excluded within 14 days prior to study entry:

- Carbamazepine.

- Terfenadine.

- Theophylline.

McDowell Clinic, Phoenix, Arizona 85006, United States

Maricopa Med Research Foundation, Phoenix, Arizona 85008, United States

San Francisco Veterans Administration Med Ctr, San Francisco, California 94121, United States

Ctr for Special Immunology, Irvine, California 92718, United States

HIV Research Group, San Diego, California 92102, United States

Highland Gen Hosp / San Francisco Gen Hosp, Oakland, California 946021018, United States

Combat Group, Los Angeles, California 90028, United States

Bay Harbor Hosp, Harbor City, California 90710, United States

Saint Francis Mem Hosp, San Francisco, California 94109, United States

Sunnyvale Med Clinic, Sunnyvale, California 94086, United States

UCSD / Ctr for Special Immunology, San Diego, California 92103, United States

Cedars Sinai Med Ctr, Los Angeles, California 90048, United States

Veterans Administration Med Ctr, Washington, District of Columbia 20422, United States

George Washington Univ Med Ctr, Washington, District of Columbia 20037, United States

TheraFirst Med Ctrs Inc, Fort Lauderdale, Florida 33308, United States

Dr Nelson Zide, Hollywood, Florida 33021, United States

Bay Area AIDS Consortium, Tampa, Florida 33609, United States

Infectious Disease Consultants, Altamonte Springs, Florida 32701, United States

Ctr for Special Immunology, Miami Beach, Florida 33140, United States

Gary Richmond MD, Fort Lauderdale, Florida 33316, United States

Dr Barry Rodwick, Safety Harbor, Florida 34695, United States

Dr Frank Tornaka, Fort Lauderdale, Florida 33316, 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

Buckley Braffman Stern Med Associates, Philadelphia, Pennsylvania 19107, United States

Polyclinic Med Ctr, Harrisburg, Pennsylvania 17110, United States

Dr Alfred F Burnside Jr, Columbia, South Carolina 29204, United States

Charleston Veterans Administration Med Ctr, Charleston, South Carolina 294015799, United States

Univ TX San Antonio Health Science Ctr, San Antonio, Texas 78284, United States

Houston Veterans Administration Med Ctr, Houston, Texas 77030, United States

Central Texas Med Foundation, Austin, Texas 78751, 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

Last updated: June 23, 2005