Evaluation of Treatment for Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mycobacterium Avium-Intracellulare Infection; HIV Infections
Intervention: Ethambutol hydrochloride (Drug); Clarithromycin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Hafner R, Study Chair
Drusano G, Study Chair
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.
Clinical Details
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
Study design: Treatment, Open Label
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.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): 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.
Locations and Contacts
Univ of Arizona / Health Science Ctr, Tucson, Arizona 85724, United States
Univ of Maryland at Baltimore, Baltimore, Maryland 21201, United States
UMDNJ - New Jersey Med School / Cooper Hosp, Camden, New Jersey 08103, United States
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
Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland, Oregon 97210, United States
Univ of Texas Southwestern Med Ctr of Dallas, Dallas, Texas 75235, United States
Richmond AIDS Consortium, Richmond, Virginia 23219, United States
Additional Information
Click here for more information about Clarithromycin
Last updated: June 23, 2005
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