Not Signed In -
Mycobacterium Avium Complex/mac |
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Clinical Trial: Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium avium Complex Disease (MAC) Plus AIDS
This study has been terminated.
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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 | Treatment or Intervention | Phase |
|---|---|---|
| Mycobacterium avium-intracellulare Infection HIV Infections | Drug: Ethambutol hydrochloride Drug: Clarithromycin Drug: Clofazimine Drug: Rifabutin | Phase III |
MedlinePlus related topics: AIDS; Bacterial Infections
Study Type: Interventional
Study Design: 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)
Expected Total Enrollment: 400
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 above, Genders Eligible for Study: Both
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).
Location Information
California
Community Consortium of San Francisco, San Francisco, California, 94110, United States
Colorado
Denver CPCRA / Denver Public Hlth, Denver, Colorado, 802044507, United States
District of Columbia
Veterans Administration Med Ctr / Regional AIDS Program, Washington, District of Columbia, 20422, United States
Georgia
AIDS Research Consortium of Atlanta, Atlanta, Georgia, 30308, United States
Illinois
AIDS Research Alliance - Chicago, Chicago, Illinois, 60657, United States
Louisiana
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med, New Orleans, Louisiana, 70112, United States
Maryland
Baltimore Trials, Baltimore, Maryland, 21201, United States
Michigan
Henry Ford Hosp, Detroit, Michigan, 48202, United States
Comprehensive AIDS Alliance of Detroit, Detroit, Michigan, 48201, United States
New Jersey
North Jersey Community Research Initiative, Newark, New Jersey, 071032842, United States
Southern New Jersey AIDS Cln Trials / Dept of Med, Camden, New Jersey, 08103, United States
New Mexico
Partners Research, Albuquerque, New Mexico, 871315271, United States
New York
Harlem AIDS Treatment Group / Harlem Hosp Ctr, New York, New York, 10037, United States
Oregon
Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland, Oregon, 972109951, United States
Pennsylvania
Philadelphia FIGHT, Philadelphia, Pennsylvania, 19107, United States
Virginia
Richmond AIDS Consortium, Richmond, Virginia, 23298, United States
Cohn D, Study Chair
Fisher E, Study Chair
Horsburgh CR, Study Chair
More Information
Click here for more information about Rifabutin
Click here for more information about Clarithromycin
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)
Cohn DL, Fisher EJ, Peng GT, Hodges JS, Chesnut J, Child CC, Franchino B, Gibert CL, El-Sadr W, Hafner R, Korvick J, Ropka M, Heifets L, Clotfelter J, Munroe D, Horsburgh CR Jr. A prospective randomized trial of four three-drug regimens in the treatment of disseminated Mycobacterium avium complex disease in AIDS patients: excess mortality associated with high-dose clarithromycin. Terry Beirn Community Programs for Clinical Research on AIDS. Clin Infect Dis. 1999 Jul;29(1):125-33.
Record last reviewed: August 1996
Last Updated: April 7, 2005
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00001047
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Simple Facts Sheets: MAC (AIDS Treatment Data Network)
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