Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mycobacterium Avium-Intracellulare Infection; HIV Infections
Intervention: Ethambutol hydrochloride (Drug); Clarithromycin (Drug); Clofazimine (Drug); Rifabutin (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Cohn D, Study Chair
Fisher E, Study Chair
Horsburgh CR, Study Chair
Summary
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.
Clinical Details
Official title: An Open-Label, Randomized Trial of Four Treatment Regimens for Patients With Disseminated Mycobacterium Avium Complex Disease and Acquired Immunodeficiency Syndrome (AIDS)
Study design: Treatment
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
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): 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).
Locations and Contacts
Community Consortium of San Francisco, San Francisco, California 94110, United States
Denver CPCRA / Denver Public Hlth, Denver, Colorado 802044507, United States
Veterans Administration Med Ctr / Regional AIDS Program, Washington, District of Columbia 20422, United States
AIDS Research Consortium of Atlanta, Atlanta, Georgia 30308, United States
AIDS Research Alliance - Chicago, Chicago, Illinois 60657, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med, New Orleans, Louisiana 70112, United States
Baltimore Trials, Baltimore, Maryland 21201, United States
Henry Ford Hosp, Detroit, Michigan 48202, United States
Comprehensive AIDS Alliance of Detroit, Detroit, Michigan 48201, United States
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
Partners Research, Albuquerque, New Mexico 871315271, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr, New York, New York 10037, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland, Oregon 972109951, United States
Philadelphia FIGHT, Philadelphia, Pennsylvania 19107, United States
Richmond AIDS Consortium, Richmond, Virginia 23298, United States
Additional Information
Click here for more information about Rifabutin Click here for more information about Clarithromycin
Related 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.
Last updated: June 23, 2005
|
