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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)


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
History of Changes
Purpose

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 2

Study Type: Interventional
Study Design: 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):

Enrollment: 24
Study Completion Date: June 2002

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

Eligibility

Ages Eligible for Study: 13 Years and older  
Sexes Eligible for Study: All  
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

Contacts and Locations

Choosing 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

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

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair: Hafner R
Study Chair: Drusano G
More Information

More Information


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
ClinicalTrials.gov Identifier: NCT00001039   History of Changes  
Other Study ID Numbers: DATRI 007  
  11739  
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
Ethambutol
Acquired Immunodeficiency Syndrome
Clarithromycin

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Clarithromycin
Ethambutol

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.