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A Study of Rifabutin, Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in Patients With AIDS
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: Pharmacia
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002343
  Purpose

To optimize Mycobacterium avium Complex (MAC) prophylaxis in AIDS patients by measuring serum rifabutin levels and adjusting the dose accordingly. To combine rifabutin with ethambutol to examine the effect of combination therapy in preventing or delaying the incidence of MAC bacteremia in this patient population.


Condition Intervention Phase
Mycobacterium Avium-Intracellulare Infection
HIV Infections
Drug: Ethambutol hydrochloride
Drug: Rifabutin
Phase IV

MedlinePlus related topics: AIDS
Drug Information available for: Rifabutin Ethambutol Ethambutol hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Pharmacodynamics Study
Official Title: An Open-Label Randomized Pharmacokinetic/Pharmacodynamic Study of Mycobutin (Rifabutin) or Rifabutin in Combination With Myambutol (Ethambutol) for Prophylaxis of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts <= 100 Cells/mm3

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

Estimated Enrollment: 200
Detailed Description:

Patients are randomized to receive oral rifabutin alone or rifabutin/ethambutol daily for 12 months, with possible continuation of medicine lifelong.

Doses will be adjusted to maintain minimum blood levels of the drugs.

  Eligibility

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

Inclusion Criteria

Concurrent Medication:

Required:

  • AZT, d4T, ddI, or ddC.
  • Antipneumocystis prophylaxis.

Allowed:

  • Short course (< 14 days) of ciprofloxacin for acute infections.

Patients must have:

  • AIDS.
  • CD4 count <= 100 cells/mm3.
  • NO prior or current MAC infection.

Prior Medication:

Required:

  • Antipneumocystis prophylaxis for at least 4 weeks prior to study entry.

Allowed:

  • Prior rifabutin.
  • Prior ethambutol.
  • Prior clarithromycin.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Positive tuberculin skin test (PPD > 5 mm).
  • Active M. tuberculosis.
  • Perceived as unreliable or unavailable for frequent monitoring.

Concurrent Medication:

Excluded:

  • Other antiretrovirals not specifically allowed.
  • All investigational drugs.
  • Other antimycobacterial therapy, such as clarithromycin, azithromycin, rifampin, clofazimine, amikacin, streptomycin, isoniazid, cycloserine, ethionamide, and ciprofloxacin (>= 14 days).

Patients with the following prior conditions are excluded:

Known hypersensitivity to rifabutin, rifampin, or other rifamycins and/or ethambutol.

Prior Medication:

Excluded within 4 weeks prior to study entry:

  • Rifampin.
  • Isoniazid.
  • Clofazimine.
  • Cycloserine.
  • Ethionamide.
  • Amikacin.
  • Ciprofloxacin.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002343

Locations
United States, California
Univ of California - Davis Med Ctr / CARES
Sacramento, California, United States, 95817
Sponsors and Collaborators
Pharmacia
  More Information

No publications provided

Study ID Numbers: 048E, CS 087287-000
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002343     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Rifabutin
Mycobacterium avium-intracellulare Infection
Drug Therapy, Combination
Ethambutol
Acquired Immunodeficiency Syndrome

Study placed in the following topic categories:
Bacterial Infections
Systemic Inflammatory Response Syndrome
Sexually Transmitted Diseases, Viral
Rifabutin
Acquired Immunodeficiency Syndrome
Bacteremia
Mycobacterium Avium Complex Infection
Mycobacterium Infections, Atypical
Immunologic Deficiency Syndromes
Inflammation
Mycobacterium avium-intracellulare Infection
Virus Diseases
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Sepsis
HIV Infections
Sexually Transmitted Diseases
Mycobacterium Infections
Ethambutol
Antitubercular Agents
Retroviridae Infections

Additional relevant MeSH terms:
Bacterial Infections
Anti-Infective Agents
Communicable Diseases
Sexually Transmitted Diseases, Viral
Rifabutin
Slow Virus Diseases
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 May 07, 2009