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Evaluation of Treatment for Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients
This study has been completed.
First Received: November 2, 1999   Last Updated: August 22, 2008   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001039
  Purpose

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 Intervention Phase
Mycobacterium Avium-Intracellulare Infection
HIV Infections
Drug: Ethambutol hydrochloride
Drug: Clarithromycin
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 24
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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001039

Locations
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 Collaborators
Investigators
Study Chair: Hafner R
Study Chair: Drusano G
  More Information

Additional Information:
No publications provided

Study ID Numbers: DATRI 007
Study First Received: November 2, 1999
Last Updated: August 22, 2008
ClinicalTrials.gov Identifier: NCT00001039     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Mycobacterium avium-intracellulare Infection
Drug Therapy, Combination
Ethambutol
Acquired Immunodeficiency Syndrome
Clarithromycin

Additional relevant MeSH terms:
Bacterial Infections
Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Clarithromycin
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Therapeutic Uses
Retroviridae Infections
RNA Virus Infections
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Pharmacologic Actions
Immunologic Deficiency Syndromes
Actinomycetales Infections
Mycobacterium Infections, Atypical
Mycobacterium avium-intracellulare Infection
Virus Diseases
Protein Synthesis Inhibitors
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Mycobacterium Infections
Ethambutol
Antitubercular Agents

ClinicalTrials.gov processed this record on February 08, 2010