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A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS

This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1992
To determine if a drug regimen containing rifabutin will eradicate or decrease the numbers of Mycobacterium avium complex (MAC) organisms in blood, improve the symptoms associated with MAC infection, and increase survival in patients with AIDS. To assess the safety of the drug regimen.

Condition Intervention
Mycobacterium Avium-Intracellulare Infection
HIV Infections
Drug: Rifabutin

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS

Resource links provided by NLM:

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 200

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Concurrent Medication:


  • Zidovudine (AZT).
  • Didanosine (ddI).

Patients must have the following:

  • Diagnosis of AIDS as defined by the CDC.
  • Blood cultures positive for Mycobacterium avium complex or for acid-fast bacilli (AFB).
  • Provide written informed consent.

Prior Medication:


  • If receiving zidovudine (AZT) or ddI must be taking the medication for at least 4 weeks prior to study entry.
  • Required:
  • Antipneumocystis prophylactic therapy for at least 4 weeks prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Known hypersensitivity to any of the study drugs.

Concurrent Medication:


  • Other therapy for mycobacterial disease.

Patients with the following are excluded:

  • Known hypersensitivity to any of the study drugs.

Prior Medication:

Excluded within 4 weeks:

  • Therapy for mycobacterial disease.
  • Antiretroviral drugs, other than zidovudine (AZT) or ddI.
  • Investigational drugs, other than ddI.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00001995

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Southwest Community Based AIDS Treatment Group - COMBAT
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AIDS Community Research Consortium
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HIV Research Group
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San Francisco Veterans Administration Med Ctr
San Francisco, California, United States, 94121
United States, District of Columbia
Veterans Administration Med Ctr
Washington, District of Columbia, United States, 20422
United States, Florida
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, United States, 33308
Ctr for Special Immunology
Fort Lauderdale, Florida, United States, 33316
Mem Hosp Hollywood
Hollywood, Florida, United States, 33021
Miami Veterans Administration Med Ctr
Miami, Florida, United States, 33125
United States, Georgia
Infectious Disease Research Consortium of Georgia
Atlanta, Georgia, United States, 30076
United States, Minnesota
Dr Frank Rhame
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Research Med Ctr
Kansas City, Missouri, United States, 64132
United States, New Jersey
North Jersey Community Research Initiative
Newark, New Jersey, United States, 071032842
United States, New York
Nassau County Med Ctr
East Meadow, New York, United States, 11554
Chelsea Village Med Ctr / Saint Vincent's Hosp
New York, New York, United States, 10014
United States, South Carolina
Dr Alfred F Burnside Jr
Columbia, South Carolina, United States, 29204
United States, Virginia
Infectious Disease Physicians Inc
Annandale, Virginia, United States, 22203
United States, Wisconsin
Milwaukee County Med Complex
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
  More Information

Dautzenberg B, Castellani P, Truffot-Pernot CH, Leng B, Sassella D. Bacteriological assessment of rifabutin versus placebo for M. avium bacteremia in AIDS patients. Int Conf AIDS. 1996 Jul 7-12;11(1):117 (abstract no MoB1359) Identifier: NCT00001995     History of Changes
Other Study ID Numbers: 048C
CS 087065
Study First Received: November 2, 1999
Last Updated: June 23, 2005

Keywords provided by NIH AIDS Clinical Trials Information Service:
Mycobacterium avium-intracellulare Infection
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Mycobacterium avium-intracellulare Infection
Mycobacterium Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Mycobacterium Infections, Nontuberculous
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antitubercular
Antitubercular Agents processed this record on May 24, 2017