Clinical trial NCT00002101: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mycobacterium Avium-Intracellulare Infection
HIV Infections
Keywords: Rifabutin
Mycobacterium avium-intracellulare Infection
Drug Therapy, Combination
Ethambutol
Acquired Immunodeficiency Syndrome
Clarithromycin
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 450
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: McDowell Clinic
state: Arizona
city: Phoenix
country: United States
facility: Maricopa Med Research Foundation
state: Arizona
city: Harbor City
country: United States
facility: Bay Harbor Hosp
state: California
city: Irvine
country: United States
facility: Ctr for Special Immunology
state: California
city: Los Angeles
country: United States
facility: Combat Group
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Med Ctr
state: California
city: Oakland
country: United States
facility: Highland Gen Hosp / San Francisco Gen Hosp
state: California
city: San Diego
country: United States
facility: HIV Research Group
state: California
city: San Diego
country: United States
facility: UCSD / Ctr for Special Immunology
state: California
city: San Francisco
country: United States
facility: Saint Francis Mem Hosp
state: California
city: San Francisco
country: United States
facility: San Francisco Veterans Administration Med Ctr
state: California
city: Sunnyvale
country: United States
facility: Sunnyvale Med Clinic
state: California
city: Washington
country: United States
facility: George Washington Univ Med Ctr
state: District of Columbia
city: Washington
country: United States
facility: Veterans Administration Med Ctr
state: District of Columbia
city: Altamonte Springs
country: United States
facility: Infectious Disease Consultants
state: Florida
city: Fort Lauderdale
country: United States
facility: TheraFirst Med Ctrs Inc
state: Florida
city: Fort Lauderdale
country: United States
facility: Dr Frank Tornaka
state: Florida
city: Fort Lauderdale
country: United States
facility: Gary Richmond MD
state: Florida
city: Hollywood
country: United States
facility: Dr Nelson Zide
state: Florida
city: Miami Beach
country: United States
facility: Ctr for Special Immunology
state: Florida
city: Safety Harbor
country: United States
facility: Dr Barry Rodwick
state: Florida
city: Tampa
country: United States
facility: Bay Area AIDS Consortium
state: Florida
city: Atlanta
country: United States
facility: Infectious Disease Research Consortium of Georgia
state: Georgia
city: Chicago
country: United States
facility: Dr Daniel Berger
state: Illinois
city: Wichita
country: United States
facility: Univ of Kansas School of Medicine
state: Kansas
city: New Orleans
country: United States
facility: Tulane Univ Med School
state: Louisiana
city: Keego Harbor
country: United States
facility: Dr Arnold Markowitz
state: Michigan
city: Omaha
country: United States
facility: Univ of Nebraska Med Ctr / HIV Clinic
state: Nebraska
city: East Orange
country: United States
facility: East Orange Veterans Administration Med Ctr
state: New Jersey
city: Newark
country: United States
facility: North Jersey Community Research Initiative
state: New Jersey
city: New Hyde Park
country: United States
facility: Long Island Jewish Med Ctr
state: New York
city: New York
country: United States
facility: Chelsea Village Med Ctr / Saint Vincent's Hosp
state: New York
city: Rochester
country: United States
facility: Community Health Network
state: New York
city: Charlotte
country: United States
facility: Nalle Clinic
state: North Carolina
city: Harrisburg
country: United States
facility: Polyclinic Med Ctr
state: Pennsylvania
city: Philadelphia
country: United States
facility: Buckley Braffman Stern Med Associates
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Veterans Administration Med Ctr
state: South Carolina
city: Columbia
country: United States
facility: Dr Alfred F Burnside Jr
state: South Carolina
city: Austin
country: United States
facility: Central Texas Med Foundation
state: Texas
city: Houston
country: United States
facility: Houston Veterans Administration Med Ctr
state: Texas
city: San Antonio
country: United States
facility: Univ TX San Antonio Health Science Ctr
state: Texas
city: Annandale
country: United States
facility: Infectious Disease Physicians Inc
state: Virginia
city: Madison
country: United States
facility: Univ of Wisconsin School of Medicine
state: Wisconsin
city: Milwaukee
country: United States
facility: Milwaukee County Med Complex
state: Wisconsin
Study officials:
References: