Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Mycobacterium Avium-intracellulare Infection

HIV Infections

Eligibility:

All Genders

13+ years

Phase:

PHASE2

Brief 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 burde...

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 treatmen...

Eligibility 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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

June 1 2002

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT00001039

End Date

June 1 2002

Last Update

October 31 2012

Active Locations (8)

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Page 1 of 2 (8 locations)

1

Univ of Arizona / Health Science Ctr

Tucson, Arizona, United States, 85724

2

Univ of Maryland at Baltimore

Baltimore, Maryland, United States, 21201

3

UMDNJ - New Jersey Med School / Cooper Hosp

Camden, New Jersey, United States, 08103

4

Albany Med College / Division of HIV Medicine A158

Albany, New York, United States, 122083479