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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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