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...
Date First Received: November 2, 1999
Last Updated: July 29, 2008
Verified by: National Institute of Allergy and Infectious Diseases (NIAID), August 1996
Clinical Trial Phase: Phase 3 | Start Date:
Overall Status: Terminated
Estimated Enrollment: 400
Brief Summary
Official Title: “An Open-Label, Randomized Trial of Four Treatment Regimens for Patients With Disseminated Mycobacterium Avium Complex Disease and Acquired Immunodeficiency Syndrome (AIDS)”
Condition Keyword(s):
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.
Study Type: Interventional
Study Design: Treatment
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Ethambutol hydrochloride
- Drug: Clarithromycin
- Drug: Clofazimine
- Drug: Rifabutin
Criteria for Participation in this Clinical Trial
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).
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 13 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Overall Clinical Trial Officials and Contacts
Cohn D Study Chair
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on January 06, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00001047
Study ID Number: CPCRA 027
ClinicalTrials.gov Identifier: NCT00001047
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
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