Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001047
First received: November 2, 1999
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

To compare the safety and efficacy of two doses of clarithromycin in combination with ethambutol and either rifabutin or clofazimine for the treatment of disseminated Mycobacterium avium Complex (MAC) disease in AIDS patients.

Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide (clarithromycin or azithromycin). However, the optimal treatment for disseminated MAC remains unknown.


Condition Intervention Phase
Mycobacterium Avium-intracellulare Infection
HIV Infections
Drug: Ethambutol hydrochloride
Drug: Clarithromycin
Drug: Clofazimine
Drug: Rifabutin
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: An Open-Label, Randomized Trial of Four Treatment Regimens for Patients With Disseminated Mycobacterium Avium Complex Disease and Acquired Immunodeficiency Syndrome (AIDS)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 400
Study Completion Date: August 1996
Detailed Description:

Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide (clarithromycin or azithromycin). However, the optimal treatment for disseminated MAC remains unknown.

Patients are randomized to receive clarithromycin at one of two doses plus ethambutol and either rifabutin or clofazimine. Patients are followed at 1, 2, and 4 months and every 4 months thereafter for a minimum of 1.5 years to a common closing date.

  Eligibility

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

Inclusion Criteria

Concurrent Medication:

Recommended in patients with CD4 count <= 200 cells/mm3:

  • Antiretroviral therapy.
  • PCP prophylaxis.

Allowed in all patients:

  • Isoniazid preventive therapy.

Patients must have:

  • HIV infection.
  • Evidence of disseminated MAC infection.

NOTE:

  • Pregnant women are permitted to enroll following counseling by their clinician regarding the potential negative side effects of the study medications. These drugs should be used in pregnancy only when the potential benefits outweigh the risks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Known hypersensitivity to the study drugs.
  • Other concurrent mycobacterial disease requiring therapy, i.e., disseminated nontuberculous mycobacterial infection or active tuberculosis.

Concurrent Medication:

Excluded:

  • Additional medications with antimycobacterial activity (unless patient is failing or intolerant of assigned study regimen).
  • Drugs with potential additive toxicity or with potential interaction with study drugs (e.g., fluconazole).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001047

Locations
United States, California
Community Consortium of San Francisco
San Francisco, California, United States, 94110
United States, Colorado
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States, 802044507
United States, District of Columbia
Veterans Administration Med Ctr / Regional AIDS Program
Washington, District of Columbia, United States, 20422
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Illinois
AIDS Research Alliance - Chicago
Chicago, Illinois, United States, 60657
United States, Louisiana
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States, 70112
United States, Maryland
Baltimore Trials
Baltimore, Maryland, United States, 21201
United States, Michigan
Henry Ford Hosp
Detroit, Michigan, United States, 48202
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, United States, 48201
United States, New Jersey
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, United States, 08103
North Jersey Community Research Initiative
Newark, New Jersey, United States, 071032842
United States, New Mexico
Partners Research
Albuquerque, New Mexico, United States, 871315271
United States, New York
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States, 10037
United States, Oregon
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States, 972109951
United States, Pennsylvania
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107
United States, Virginia
Richmond AIDS Consortium
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Investigators
Study Chair: Cohn D
Study Chair: Fisher E
Study Chair: Horsburgh CR
  More Information

Additional Information:
Publications:
Cohn D, Fisher E, Franchino B, Peng G, Hodges J, Chesnut J, Child C, Gibert C, El-Sadr W, Hafner R, Ropka M, Heifets L, Clotfelter J, Munroe D, Caldwell R, Horsburgh R. A prospective, randomized trial of four 3-drug regimens for treatment(Rx) of disseminated MAC disease in AIDS(DM): excess mortality associated with high-dose clarithromycin(C). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:186 (abstract no 659)

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001047     History of Changes
Other Study ID Numbers: CPCRA 027, 11577
Study First Received: November 2, 1999
Last Updated: March 30, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Rifabutin
Mycobacterium avium-intracellulare Infection
Drug Therapy, Combination
Ethambutol
Clofazimine
Acquired Immunodeficiency Syndrome
Clarithromycin

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Atypical
Clofazimine
Ethambutol
Clarithromycin
Rifabutin
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on April 14, 2014