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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

March 30, 2012

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00001047 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open-Label, Randomized Trial of Four Treatment Regimens for Patients With Disseminated Mycobacterium Avium Complex Disease and Acquired Immunodeficiency Syndrome (AIDS)

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.

Detailed Description

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Mycobacterium Avium-intracellulare Infection
HIV Infections

Intervention ^ICMJE

Drug: Ethambutol hydrochloride
Drug: Clarithromycin
Drug: Clofazimine
Drug: Rifabutin

Study Arm (s)

Not Provided

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

400

Completion Date

August 1996

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Both

Ages

13 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00001047

Other Study ID Numbers ^ICMJE

CPCRA 027, 11577

Has Data Monitoring Committee

Not Provided

Responsible Party

National Institute of Allergy and Infectious Diseases (NIAID)

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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