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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002331
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : January 16, 2015
Information provided by:

Brief Summary:

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 or disease Intervention/treatment Phase
Mycobacterium Avium-intracellular Infection HIV Infections Drug: Ethambutol hydrochloride Drug: Clarithromycin Drug: Clofazimine Not Applicable

Study Type : Interventional  (Clinical Trial)
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
Study Start Date : January 1994
Actual Primary Completion Date : March 1995
Actual Study Completion Date : March 1995

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


  • 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:


  • 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:


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002331

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

Publications: Identifier: NCT00002331     History of Changes
Other Study ID Numbers: 214A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: January 16, 2015
Last Verified: February 2009

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

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
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
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Nontuberculous
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antitubercular Agents
Anti-Inflammatory Agents
Leprostatic Agents