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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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00001995
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1992
History of Changes
  Purpose

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: Endpoint Classification: Safety Study
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:

Drug Information available for: Rifabutin
U.S. FDA Resources

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

Estimated Enrollment: 200
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • 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:

Allowed:

  • 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:

Excluded:

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001995

Locations
United States, Arizona
Maricopa County Med Ctr
Phoenix, Arizona, United States, 85010
United States, California
Bay Harbor Hosp
Harbor City, California, United States, 90710
Ctr for Special Immunology
Irvine, California, United States, 92718
Southwest Community Based AIDS Treatment Group - COMBAT
Los Angeles, California, United States, 90028
AIDS Community Research Consortium
Redwood City, California, United States, 94063
HIV Research Group
San Diego, California, United States, 92102
San Francisco Veterans Administration Med Ctr
San Francisco, California, United States, 94121
Davies Med Ctr
San Francisco, California, United States, 94114
United States, District of Columbia
Veterans Administration Med Ctr
Washington, District of Columbia, United States, 20422
United States, Florida
Ctr for Special Immunology
Fort Lauderdale, Florida, United States, 33316
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, United States, 33308
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
Pharmacia
  More Information

Publications:
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)

ClinicalTrials.gov Identifier: NCT00001995     History of Changes
Other Study ID Numbers: 048C, CS 087065
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Bacteremia
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Bacterial Infections
 Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Actinomycetales Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections, Atypical
Rifabutin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antitubercular
Antitubercular Agents

ClinicalTrials.gov processed this record on May 22, 2013