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	Treatment or Intervention	Phase
Mycobacterium avium-intracellulare Infection HIV Infections	Drug: Ethambutol hydrochloride  Drug: Clarithromycin	Phase II

Further Study Details: 

Expected Total Enrollment:  24

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.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

Arizona
      Univ of Arizona / Health Science Ctr, Tucson,  Arizona,  85724,  United States
Maryland
      Univ of Maryland at Baltimore, Baltimore,  Maryland,  21201,  United States
New Jersey
      UMDNJ - New Jersey Med School / Cooper Hosp, Camden,  New Jersey,  08103,  United States
New York
      Albany Med College / Division of HIV Medicine A158, Albany,  New York,  122083479,  United States
      SUNY / Health Sciences Ctr at Stony Brook, Stony Brook,  New York,  117948153,  United States
Oregon
      Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland,  Oregon,  97210,  United States
Texas
      Univ of Texas Southwestern Med Ctr of Dallas, Dallas,  Texas,  75235,  United States
Virginia
      Richmond AIDS Consortium, Richmond,  Virginia,  23219,  United States

Study chairs or principal investigators

Hafner R,  Study Chair
Drusano G,  Study Chair

Study ID Numbers:  DATRI 007
Record last reviewed:  May 1995
Last Updated:  April 7, 2005
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00001039
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08