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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002343
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1997
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
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: 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

ClinicalTrials.gov Identifier: NCT00002343     History of Changes
Other Study ID Numbers: 048E, CS 087287-000
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
Mycobacterium avium-intracellulare Infection
Drug Therapy, Combination
Ethambutol
Acquired Immunodeficiency Syndrome

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

ClinicalTrials.gov processed this record on August 21, 2014