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

Phase 2

Completed

• Conditions: Mycobacterium Avium-intracellulare Infection; HIV Infections

• Registration Number: NCT00001039
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Detailed Description

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.

Patients receive both clarithromycin and ethambutol for 48 weeks; those who become intolerant to the study drugs may receive suggested substitute drugs (azithromycin and rifabutin). Patients receive a bone marrow biopsy at baseline and at either 4 or 8 weeks. Patients are evaluated at weeks 1, 2, 4, 6, 8, 12, 24, 36, and 48.

Study Timeline

• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Study Completion: 2002-06
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-29
• Last Update Posted: 2012-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (8)

Univ of Arizona / Health Science Ctr; 🇺🇸 Tucson, Arizona, United States

Univ of Maryland at Baltimore; 🇺🇸 Baltimore, Maryland, United States

UMDNJ - New Jersey Med School / Cooper Hosp; 🇺🇸 Camden, New Jersey, United States

Albany Med College / Division of HIV Medicine A158; 🇺🇸 Albany, New York, United States

SUNY / Health Sciences Ctr at Stony Brook; 🇺🇸 Stony Brook, New York, United States

Portland Veterans Adm Med Ctr / Rsch & Education Grp; 🇺🇸 Portland, Oregon, United States

Univ of Texas Southwestern Med Ctr of Dallas; 🇺🇸 Dallas, Texas, United States

Richmond AIDS Consortium; 🇺🇸 Richmond, Virginia, United States