The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00002331
First received: November 2, 1999
Last updated: February 19, 2009
Last verified: February 2009
  Purpose

PRIMARY: To assess the tolerability of the combination regimen of clarithromycin plus ethambutol with or without clofazimine in patients with disseminated Mycobacterium avium Complex (dMAC).

SECONDARY: To determine the proportion of patients achieving a sterile blood culture along with the time required to achieve it. To determine the duration of bacteriological response, defined as length of time that blood cultures remain sterile.


Condition Intervention
Mycobacterium Avium-intracellular Infection
HIV Infections
Drug: Ethambutol hydrochloride
Drug: Clarithromycin
Drug: Clofazimine

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
Official Title: A Randomized Open-Label Study of the Tolerability and Efficacy of Clarithromycin and Ethambutol in Combination With or Without Clofazimine for the Treatment of Disseminated MAC (dMAC) in Patients With AIDS

Resource links provided by NLM:


Further study details as provided by Abbott:

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients must have:

  • History of HIV seropositivity.
  • Disseminated MAC.
  • Positive blood culture for MAC within 4 weeks prior to study entry.
  • Consent of parent or guardian if less than 18 years of age.
  • Ability to complete the study.

NOTE:

  • Patients with active opportunistic infections other than dMAC are permitted if dosage and clinical parameters have been stable for 4 weeks prior to enrollment.

Exclusion Criteria

Concurrent Medication:

Excluded:

  • Active therapy with carbamazepine or theophylline, unless investigator agrees to carefully monitor blood levels.
  • Active therapy with investigational drugs other than treatment for HIV disease, except with approval of the sponsor.
  • Concomitant terfenadine (Seldane or Seldane-D) or astemizole (Hismanal).
  • Amikacin.
  • Azithromycin.
  • Capreomycin.
  • Ciprofloxacin.
  • Cycloserine.
  • Ethionamide.
  • Gentamicin.
  • Kanamycin.
  • Levofloxacin.
  • Lomefloxacin.
  • Ofloxacin.
  • Rifampin.
  • Rifabutin.
  • Sparfloxacin.
  • Streptomycin.
  • Any other aminoglycosides, quinolones, and macrolides.

Patients with the following prior conditions are excluded:

History of allergy or hypersensitivity to macrolides, ethambutol, or clofazimine.

Prior Medication:

Excluded:

  • Other antimycobacterials, including aminoglycosides, ansamycin (rifabutin), other macrolides (such as clindamycin), quinolones, and rifampin, between screening and study entry.
  • Clarithromycin or azithromycin as prophylaxis or treatment (for any cause) for more than 14 days cumulative within the past 2 months.
  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: NCT00002331

Locations
United States, California
Kaiser Permanente Med Ctr
Los Angeles, California, United States, 90027
UCD Med Ctr
Sacramento, California, United States, 95817
Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
Santa Clara Valley Med Ctr
San Jose, California, United States, 951282699
United States, District of Columbia
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
United States, Florida
Dr Margaret Fischel
Miami, Florida, United States, 33136
Saint Joseph's Hosp / Infectious Disease Rsch Institute
Tampa, Florida, United States, 33614
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
United States, Louisiana
Tulane Univ Med School
New Orleans, Louisiana, United States, 701122699
United States, Maryland
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, United States, 21205
United States, New York
Beth Israel Med Ctr
New York, New York, United States, 10003
Mount Sinai Med Ctr
New York, New York, United States, 10029
United States, North Carolina
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, United States, 275997215
United States, Pennsylvania
Dr Stephen Hauptman
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Vanderbilt Univ School of Medicine
Nashville, Tennessee, United States, 37212
United States, Texas
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States, 75235
Houston Veterans Administration Med Ctr
Houston, Texas, United States, 77030
Puerto Rico
Dr Javier Morales
Condado San Juan, Puerto Rico, 00907
Sponsors and Collaborators
Abbott
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002331     History of Changes
Other Study ID Numbers: 214A, M93-069
Study First Received: November 2, 1999
Last Updated: February 19, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Mycobacterium avium-intracellular Infection
Drug Therapy, Combination
Ethambutol
Clofazimine
Acquired Immunodeficiency Syndrome
Clarithromycin

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
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
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Nontuberculous
Clofazimine
Ethambutol
Clarithromycin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 11, 2014