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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002032
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 1992
  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: Masking: Double-Blind
Primary Purpose: Treatment
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002032

  Hide Study Locations
Locations
United States, California
Ctr for Special Immunology
Irvine, California, United States, 92718
Olive View Med Ctr
Sylmar, California, United States, 91342
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
Ctr for Special Immunology
Fort Lauderdale, Florida, United States, 33308
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
United States, Georgia
Grady Memorial Hosp / Hughs Spalding Med Ctr
Atlanta, Georgia, United States, 30335
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
Dr Winkler Weinberg
Roswell, Georgia, United States, 30076
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
Research Med Ctr
Kansas City, Missouri, United States, 64132
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, United States, 64108
United States, New York
Brooklyn Veterans Administration
Brooklyn, New York, United States, 11209
Maimonides Med Ctr
Brooklyn, New York, United States, 11219
Nassau County Med Ctr
East Meadow, New York, United States, 11554
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
Chelsea Village Med Ctr
New York, New York, United States, 10014
Community Research Initiative
New York, New York, United States, 10011
United States, Ohio
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
Ohio State Univ Med Ctr
Columbus, Ohio, United States, 43210
United States, Texas
Central Texas Med Foundation
Austin, Texas, United States, 78751
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States, 75235
Nelson Tebedo Community Clinic
Dallas, Texas, United States, 75219
Texas Tech Health Sciences Ctr
El Paso, Texas, United States, 79905
Houston Clinical Research Network
Houston, Texas, United States, 77266
Baylor College of Medicine
Houston, Texas, United States, 77005
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, United States, 78284
Scott and White Hosp
Temple, Texas, United States, 76508
Dr Scott Lea
Waco, Texas, United States, 76708
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: NCT00002032     History of Changes
Other Study ID Numbers: 048A, 087023-999
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
AIDS-Related Opportunistic Infections
Mycobacterium avium-intracellulare Infection
Acquired Immunodeficiency Syndrome
Antitubercular Agents

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
Antitubercular Agents
Rifabutin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antitubercular

ClinicalTrials.gov processed this record on July 24, 2014