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:
NCT00002267
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1992
  Purpose

The primary objective of this trial is to assess the safety and the relative benefit of rifabutin monotherapy in preventing or delaying the incidence of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200, as compared to placebo, and to assess if survival is prolonged in patients who receive rifabutin prophylaxis.


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 obtained, which must include a statement that treatment may involve risks to the embryo or fetus, which are currently unforeseeable, if the subject becomes pregnant.

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: NCT00002267

  Hide Study Locations
Locations
United States, Arizona
Maricopa County Med Ctr
Phoenix, Arizona, United States, 85010
United States, California
East Bay AIDS Ctr
Berkeley, California, United States, 94704
Pacific Oaks Med Group
Beverly Hills, California, United States, 90211
AIDS Community Research Consortium
Redwood City, California, United States, 94063
HIV Research Group
San Diego, California, United States, 92102
Dr Marcus Conant
San Francisco, California, United States, 94115
San Francisco Veterans Administration Med Ctr
San Francisco, California, United States, 94121
Dr Larry A Waites
San Francisco, California, United States, 94108
Saint Francis Mem Hosp / HIV Care
San Francisco, California, United States, 94109
Dr Marshall Kubota
Santa Rosa, California, United States, 95404
Dr Jeffrey Galpin
Tarzana, California, United States, 91356
United States, Florida
Community Research Initiative of South Florida
Miami, Florida, United States, 33137
Miami Veterans Administration Med Ctr
Miami, Florida, United States, 33125
United States, Illinois
AIDS Research Alliance - Chicago
Chicago, Illinois, United States, 60657
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
United States, Louisiana
Tulane Univ School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Michigan
Comprehensive AIDS Alliance of Detroit / Harper Hosp
Detroit, Michigan, United States, 48201
United States, Minnesota
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
St Paul Ramsey Med Ctr
St Paul, Minnesota, United States, 55101
United States, Nevada
Univ of Nevada / Veterans Administration Med Ctr
Reno, Nevada, United States, 89520
United States, New Jersey
North Jersey Community Research Initiative
Newark, New Jersey, United States, 071032842
United States, New Mexico
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
Albuquerque, New Mexico, United States, 87131
Dr Donald Romig
Sante Fe, New Mexico, United States, 87501
United States, New York
Albany Veterans Administration
Albany, New York, United States, 12208
AIDS Services Erie County Med Ctr
Buffalo, New York, United States, 14215
Community Health Network
Rochester, New York, United States, 14620
United States, Pennsylvania
Thomas Jefferson Med College
Philadelphia, Pennsylvania, United States, 19107
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States, 19107
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
Canada, Alberta
Univ of Calgary Health Science Ctr
Calgary, Alberta, Canada
Univ of Alberta/Division of Inf Dis/Dept of Med
Edmonton, Alberta, Canada
Canada, British Columbia
Saint Paul's Hosp
Vancouver, British Columbia, Canada
Canada, Nova Scotia
Victoria Gen Hosp
Halifax, Nova Scotia, Canada
Canada, Ontario
McMaster Univ Med Ctr
Hamilton, Ontario, Canada
Ottawa Gen Hosp
Ottawa, Ontario, Canada
Mount Sinai Hosp
Toronto, Ontario, Canada
Sunnybrook Health Science Ctr
Toronto, Ontario, Canada
Saint Michael's Hosp
Toronto, Ontario, Canada
Canada, Quebec
Montreal Chest Institute
Montreal, Quebec, Canada
Dr Emil Toma / Hotel Dieu de Montreal
Montreal, Quebec, Canada
Montreal Gen Hosp
Montreal, Quebec, Canada
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: NCT00002267     History of Changes
Other Study ID Numbers: 048B, 087027-999
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:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Mycobacterium Infections
Bacteremia
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
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Mycobacterium Infections, Nontuberculous
Rifabutin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antitubercular

ClinicalTrials.gov processed this record on October 19, 2014