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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.
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
History of Changes
  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:

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

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

  Show 33 Study Locations
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 May 23, 2013