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

NCT00001047 | Completed Phase 3

• 2 other identifiers: CPCRA 02711577
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 16

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.

Conditions

Mycobacterium Avium-intracellulare Infection; HIV Infections

Keywords

Rifabutin; Mycobacterium avium-intracellulare Infection; Drug Therapy, Combination; Ethambutol; Clofazimine; Acquired Immunodeficiency Syndrome; Clarithromycin

Interventions

Ethambutol hydrochloride DRUG

Clarithromycin DRUG

Clofazimine DRUG

Rifabutin DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (16)

Community Consortium of San Francisco

San Francisco, California, 94110, United States

Location

Denver CPCRA / Denver Public Hlth

Denver, Colorado, 802044507, United States

Location

Veterans Administration Med Ctr / Regional AIDS Program

Washington D.C., District of Columbia, 20422, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 30308, United States

Location

AIDS Research Alliance - Chicago

Chicago, Illinois, 60657, United States

Location

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med

New Orleans, Louisiana, 70112, United States

Location

Baltimore Trials

Baltimore, Maryland, 21201, United States

Location

Comprehensive AIDS Alliance of Detroit

Detroit, Michigan, 48201, United States

Location

Henry Ford Hosp

Detroit, Michigan, 48202, United States

Location

Southern New Jersey AIDS Cln Trials / Dept of Med

Camden, New Jersey, 08103, United States

Location

North Jersey Community Research Initiative

Newark, New Jersey, 071032842, United States

Location

Partners Research

Albuquerque, New Mexico, 871315271, United States

Location

Harlem AIDS Treatment Group / Harlem Hosp Ctr

New York, New York, 10037, United States

Location

Portland Veterans Adm Med Ctr / Rsch & Education Grp

Portland, Oregon, 972109951, United States

Location

Philadelphia FIGHT

Philadelphia, Pennsylvania, 19107, United States

Location

Richmond AIDS Consortium

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• 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. doi: 10.1086/520141.

  PMID: 10433575 BACKGROUND

MeSH Terms

Conditions

Mycobacterium avium-intracellulare Infection; HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Ethambutol; Clarithromycin; Clofazimine; Rifabutin

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Erythromycin; Macrolides; Polyketides; Lactones; Phenazines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Cohn D

  STUDY CHAIR

• Fisher E

  STUDY CHAIR

• Horsburgh CR

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: August 1, 1996
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (16)