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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001039
First received: November 2, 1999
Last updated: October 29, 2012
Last verified: October 2012

November 2, 1999
October 29, 2012
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Complete list of historical versions of study NCT00001039 on ClinicalTrials.gov Archive Site
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Evaluation of Treatment for Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients
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

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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
  • Mycobacterium Avium-intracellulare Infection
  • HIV Infections
  • Drug: Ethambutol hydrochloride
  • Drug: Clarithromycin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 2002
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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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001039
DATRI 007, 11739
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National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Hafner R
Study Chair: Drusano G
National Institute of Allergy and Infectious Diseases (NIAID)
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP