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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001039
• Other study ID #: DATRI 007
• Secondary ID: 11739
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: October 29, 2012
• Est. completion date: June 2002

Study information

• Verified date: October 2012
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infection
• Mycobacterium Avium-intracellulare Infection
• Mycobacterium Infections

Intervention

Drug:
• Ethambutol hydrochloride

• Clarithromycin

Locations

Country	Name	City	State
United States	Albany Med College / Division of HIV Medicine A158	Albany	New York
United States	Univ of Maryland at Baltimore	Baltimore	Maryland
United States	UMDNJ - New Jersey Med School / Cooper Hosp	Camden	New Jersey
United States	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas
United States	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon
United States	Richmond AIDS Consortium	Richmond	Virginia
United States	SUNY / Health Sciences Ctr at Stony Brook	Stony Brook	New York
United States	Univ of Arizona / Health Science Ctr	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

External Links

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