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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.

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 hydrochloride    Ethambutol   

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


Study ID Numbers:   048E, CS 087287-000
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002343
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 Infections, Atypical
Immunologic Deficiency Syndromes
Inflammation
Mycobacterium avium-intracellulare Infection
Virus Diseases
Gram-Positive Bacterial Infections
Sepsis
HIV Infections
Sexually Transmitted Diseases
Mycobacterium Infections
Ethambutol
Mycobacterium avium complex infection
Retroviridae Infections

Additional relevant MeSH terms:
Communicable Diseases
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Infection
Actinomycetales Infections
Pharmacologic Actions
Antibiotics, Antitubercular
Anti-Bacterial Agents
Pathologic Processes
Therapeutic Uses
Lentivirus Infections
Antitubercular Agents

ClinicalTrials.gov processed this record on December 03, 2008




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