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Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsor: Pharmacia
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002032
  Purpose

The primary objectives of this trial are: To compare the safety of oral rifabutin versus placebo in the treatment of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200 cells/mm3. To investigate the incidence of MAC in these patients. A secondary objective is to compare clinical response, quality of life (Karnofsky), and survival between these two groups.


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

Study Type: Interventional
Study Design: Treatment, Double-Blind
Official Title: Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial

Resource links provided by NLM:


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

Estimated Enrollment: 750
  Eligibility

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

Inclusion Criteria

Patients must have the following:

  • Diagnosis of AIDS with a case defining infection other than Mycobacterium avium complex (MAC).
  • Written informed consent.
  • Females of childbearing potential must also sign a special informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine or didanosine (ddI).
  • Previous or current infection due to Mycobacterium avium complex (MAC) disease as evaluated by two successive blood cultures and two successive stool cultures taken within 14 days prior to study initiation.

Concurrent Medication:

Excluded:

  • Antiretroviral agents other than zidovudine (AZT).
  • Didanosine (ddI).
  • Antimycobacterial therapy.
  • Rifampin.
  • Isoniazid.
  • Clofazimine.
  • Ethambutol.
  • Cycloserine.
  • Ethionamide.
  • Amikacin.
  • Ciprofloxacin.
  • Streptomycin.
  • Other investigational drugs.
  • If antimicrobial therapy is required to treat bacterial infections (= or < 14 days), Adria Laboratories must be contacted prior to initiation of therapy.

Patients with the following are excluded:

  • Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine (AZT), or didanosine (ddI).
  • Previous or current Mycobacterium avium complex (MAC) infection.
  • Perceived patient unreliability or unavailability for frequent monitoring.

Prior Medication:

Excluded within 4 weeks of study entry:

  • Antiretroviral agents other than zidovudine (AZT) or didanosine (ddI).
  • Antimycobacterial therapy.
  • Rifampin.
  • Isoniazid.
  • Clofazimine.
  • Ethambutol.
  • Cycloserine.
  • Ethionamide.
  • Amikacin.
  • Ciprofloxacin.

Required:

  • Zidovudine (AZT).
  • Antipneumocystis prophylactic therapy.

Required for at least 4 weeks prior to study entry:

  • Zidovudine (AZT) or didanosine (ddI).
  • Antipneumocystis prophylaxis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002032

  Hide Study Locations
Locations
United States, California
Olive View Med Ctr
Sylmar, California, United States, 91342
Ctr for Special Immunology
Irvine, California, United States, 92718
United States, Colorado
Denver Public Health Dept
Denver, Colorado, United States, 80204
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
Mem Hosp Hollywood
Hollywood, Florida, United States, 33021
VP Med Services / HHCS Research Institute Inc
Orlando, Florida, United States, 32806
Ctr for Special Immunology
Fort Lauderdale, Florida, United States, 33308
United States, Georgia
Grady Memorial Hosp / Hughs Spalding Med Ctr
Atlanta, Georgia, United States, 30335
Dr Winkler Weinberg
Roswell, Georgia, United States, 30076
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21205
United States, Massachusetts
CRI of New England
Brookline, Massachusetts, United States, 02445
United States, Missouri
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, United States, 64108
Research Med Ctr
Kansas City, Missouri, United States, 64132
United States, New York
Nassau County Med Ctr
East Meadow, New York, United States, 11554
Brooklyn Veterans Administration
Brooklyn, New York, United States, 11209
Chelsea Village Med Ctr
New York, New York, United States, 10014
Maimonides Med Ctr
Brooklyn, New York, United States, 11219
Community Research Initiative
New York, New York, United States, 10011
Long Island Jewish Med Ctr
New Hyde Park, New York, United States, 11042
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021
United States, Ohio
Ohio State Univ Med Ctr
Columbus, Ohio, United States, 43210
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
United States, Texas
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, United States, 78284
Central Texas Med Foundation
Austin, Texas, United States, 78751
Nelson Tebedo Community Clinic
Dallas, Texas, United States, 75219
Dr Scott Lea
Waco, Texas, United States, 76708
Scott and White Hosp
Temple, Texas, United States, 76508
Texas Tech Health Sciences Ctr
El Paso, Texas, United States, 79905
Baylor College of Medicine
Houston, Texas, United States, 77005
Houston Clinical Research Network
Houston, Texas, United States, 77266
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States, 75235
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)
Moore RD, Chaisson RE. Survival analysis of two controlled trials of rifabutin prophylaxis against Mycobacterium avium complex in AIDS. AIDS. 1995 Dec;9(12):1337-42.

Study ID Numbers: 048A, 087023-999
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002032     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Rifabutin
AIDS-Related Opportunistic Infections
Mycobacterium avium-intracellulare Infection
Acquired Immunodeficiency Syndrome
Antitubercular Agents

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

ClinicalTrials.gov processed this record on November 22, 2009