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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00001039

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mycobacterium Avium-intracellulare Infection HIV Infections	Drug: Ethambutol hydrochloride Drug: Clarithromycin	Phase 2

Detailed Description

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 Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effect of Therapy on the Tissue Burden of Disseminated MAC Infection as Measured by Quantitative Bone Marrow Culture and Correlation With Quantitative Blood Culture in HIV-Infected Patients

Actual Study Completion Date :

Jun 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

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.

Exclusion Criteria

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.
Acute therapy for an AIDS-related opportunistic infection or malignancy, or other acute medical illness or infection within 4 weeks prior to study entry.
Rifabutin monotherapy if initiated for MAC prophylaxis between the time an initial AFB positive blood sample was collected and study entry.
Aminoglycosides, quinolones, clofazimine, or rifamycins IF ADMINISTERED IN ANY COMBINATION within 7 days prior to study entry OR between the time an initial AFB positive blood sample was collected and study entry.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Arizona / Health Science Ctr	Tucson	Arizona	United States	85724
2	Univ of Maryland at Baltimore	Baltimore	Maryland	United States	21201
3	UMDNJ - New Jersey Med School / Cooper Hosp	Camden	New Jersey	United States	08103
4	Albany Med College / Division of HIV Medicine A158	Albany	New York	United States	122083479
5	SUNY / Health Sciences Ctr at Stony Brook	Stony Brook	New York	United States	117948153
6	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon	United States	97210
7	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas	United States	75235
8	Richmond AIDS Consortium	Richmond	Virginia	United States	23219