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

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00001047
• Collaborator: (none)
• Enrollment: 400
• Locations: 16
• Patients Per Site: 25

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Mycobacterium Avium-intracellulare Infection; HIV Infections	Drug: Ethambutol hydrochloride; Drug: Clarithromycin; Drug: Clofazimine; Drug: Rifabutin	Phase 3

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.

Study Design

• Study Type: Interventional
• 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)
• Actual Study Completion Date: Aug 1, 1996

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Community Consortium of San Francisco	San Francisco	California	United States	94110
2	Denver CPCRA / Denver Public Hlth	Denver	Colorado	United States	802044507
3	Veterans Administration Med Ctr / Regional AIDS Program	Washington	District of Columbia	United States	20422
4	AIDS Research Consortium of Atlanta	Atlanta	Georgia	United States	30308
5	AIDS Research Alliance - Chicago	Chicago	Illinois	United States	60657
6	Louisiana Comm AIDS Rsch Prog / Tulane Univ Med	New Orleans	Louisiana	United States	70112
7	Baltimore Trials	Baltimore	Maryland	United States	21201
8	Comprehensive AIDS Alliance of Detroit	Detroit	Michigan	United States	48201
9	Henry Ford Hosp	Detroit	Michigan	United States	48202
10	Southern New Jersey AIDS Cln Trials / Dept of Med	Camden	New Jersey	United States	08103
11	North Jersey Community Research Initiative	Newark	New Jersey	United States	071032842
12	Partners Research	Albuquerque	New Mexico	United States	871315271
13	Harlem AIDS Treatment Group / Harlem Hosp Ctr	New York	New York	United States	10037
14	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon	United States	972109951
15	Philadelphia FIGHT	Philadelphia	Pennsylvania	United States	19107
16	Richmond AIDS Consortium	Richmond	Virginia	United States	23298

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Study Chair: Cohn D,
• Study Chair: Fisher E,
• Study Chair: Horsburgh CR,

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT00001047
• Other Study ID Numbers: CPCRA 027; 11577
• First Posted: Aug 31, 2001
• Last Update Posted: Nov 4, 2021
• Last Verified: Oct 1, 2021

• 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: Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome; Mycobacterium Infections; Mycobacterium avium-intracellulare Infection; Clarithromycin; Ethambutol; Rifabutin; Clofazimine

Study Results

No Results Posted as of Nov 4, 2021