Evaluation of Treatment for Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients

NCT00001039 | Completed Phase 2

• 2 other identifiers: DATRI 00711739
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 8

Brief Summary

To assess the feasibility of using culture and staining techniques to quantify tissue Mycobacterium avium Complex (MAC) burden in bone marrow. To correlate and compare changes in MAC bone marrow burden with quantitative MAC blood culture results at baseline and after 4 and 8 weeks of treatment. MAC is easiest to detect in the blood, although doctors generally believe that MAC in blood is just "spill-over" from infection of other parts of the body. Traditionally, studies of potential treatments for MAC focus only on MAC changes in the blood. This study compares MAC changes in blood to those in bone marrow, which is another tissue where MAC is often found.

Conditions

Mycobacterium Avium-intracellulare Infection; HIV Infections

Keywords

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

Interventions

Ethambutol hydrochloride DRUG

Clarithromycin 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:
• Allowed:
• Any antiretroviral therapy that is approved or is available through an FDA-sanctioned treatment IND or treatment protocol.
• Primary or secondary PCP prophylaxis with TMP/SMX, dapsone, or aerosolized pentamidine, as well as approved therapies for other AIDS-related opportunistic infections not otherwise excluded.
• Erythromycin, interferon-alpha, and supportive care for any therapy-related toxicities as necessary.
• Patients must have:
• HIV infection.
• Confirmed MAC bacteremia.
• Consent of parent or guardian if less than 18 years of age.

You may not qualify if:

• Concurrent Medication:
• Excluded:
• MAC inhibitors, including aminoglycosides, quinolones, clofazimine, azithromycin (except when administered as a substitute drug), and rifamycins, during the first 24 weeks of the study.
• Immunomodulators (including colony-stimulating cytokines such as GM-CSF and G-CSF) other than those that are specifically allowed.
• Steroids in excess of physiologic replacement doses.
• Cytotoxic chemotherapy.
• Patients with the following prior conditions are excluded:
• History of treatment-limiting intolerance or hypersensitivity to the study drugs or other macrolides.
• Changes on chest radiograph within 7 days prior to study entry, that are consistent with acute Pneumocystis carinii pneumonia, pulmonary tuberculosis, or other acute respiratory infection.
• Prior Medication:
• Excluded:
• Clarithromycin, azithromycin, or ethambutol for more than 10 consecutive days within the 8 weeks prior to study entry OR between the time an initial AFB positive blood sample was collected and study entry.
• Cytokines (other than erythropoietin and interferon-alpha) within 8 weeks prior to study entry.
• Steroids within 8 weeks prior to study entry.
• Cytotoxic chemotherapy within 8 weeks prior to study entry.

Sponsors & Collaborators

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

Study Sites (8)

Univ of Arizona / Health Science Ctr

Tucson, Arizona, 85724, United States

Location

Univ of Maryland at Baltimore

Baltimore, Maryland, 21201, United States

Location

UMDNJ - New Jersey Med School / Cooper Hosp

Camden, New Jersey, 08103, United States

Location

Albany Med College / Division of HIV Medicine A158

Albany, New York, 122083479, United States

Location

SUNY / Health Sciences Ctr at Stony Brook

Stony Brook, New York, 117948153, United States

Location

Portland Veterans Adm Med Ctr / Rsch & Education Grp

Portland, Oregon, 97210, United States

Location

Univ of Texas Southwestern Med Ctr of Dallas

Dallas, Texas, 75235, United States

Location

Richmond AIDS Consortium

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

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

Interventions

Ethambutol; Clarithromycin

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

Study Officials

• Hafner R

  STUDY CHAIR

• Drusano G

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: June 1, 2002
• Last Updated: October 31, 2012

Record last verified: 2012-10

Locations

US (8)