Evaluation of Treatment for Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
First received: November 2, 1999
Last updated: October 29, 2012
Last Verified: October 2012
History of Changes
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.
Mycobacterium Avium-intracellulare Infection
Drug : Ethambutol hydrochloride
Drug : Clarithromycin
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|
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
|Study Completion Date:||June 2002|
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 older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- HIV infection.
- Confirmed MAC bacteremia.
- Consent of parent or guardian if less than 18 years of age.
- 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.
- 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.
- 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
Patients must have:
Patients with the following prior conditions are excluded:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001039
Locations Show More
|United States, Arizona|
|Univ of Arizona / Health Science Ctr|
|Tucson, Arizona, United States, 85724|
|United States, Maryland|
|Univ of Maryland at Baltimore|
|Baltimore, Maryland, United States, 21201|
|United States, New Jersey|
|UMDNJ - New Jersey Med School / Cooper Hosp|
|Camden, New Jersey, United States, 08103|
|United States, New York|
|Albany Med College / Division of HIV Medicine A158|
|Albany, New York, United States, 122083479|
|SUNY / Health Sciences Ctr at Stony Brook|
|Stony Brook, New York, United States, 117948153|
|United States, Oregon|
|Portland Veterans Adm Med Ctr / Rsch & Education Grp|
|Portland, Oregon, United States, 97210|
|United States, Texas|
|Univ of Texas Southwestern Med Ctr of Dallas|
|Dallas, Texas, United States, 75235|
|United States, Virginia|
|Richmond AIDS Consortium|
|Richmond, Virginia, United States, 23219|
Sponsors and CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)
|Study Chair:||Hafner R|
|Study Chair:||Drusano G|
|Responsible Party:||National Institute of Allergy and Infectious Diseases (NIAID)|
|ClinicalTrials.gov Identifier:||NCT00001039 History of Changes|
|Other Study ID Numbers:||DATRI 007|
|Study First Received:||November 2, 1999|
|Last Updated:||October 29, 2012|
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):Mycobacterium avium-intracellulare Infection
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
Mycobacterium avium-intracellulare Infection
ClinicalTrials.gov processed this data on June 01, 2020
This information is provided by ClinicalTrials.gov.