Evaluation of Treatment for Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients
Completed · Phase 2
Conditions studied: Mycobacterium Avium-intracellulare Infection, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00001039
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 24
- Expected to finish
- 2002-06-01
- Last updated by the study team
- 2012-10-31
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Univ of Arizona / Health Science Ctr — Tucson, Arizona, United States
- Univ of Maryland at Baltimore — Baltimore, Maryland, United States
- UMDNJ - New Jersey Med School / Cooper Hosp — Camden, New Jersey, United States
- Albany Med College / Division of HIV Medicine A158 — Albany, New York, United States
- SUNY / Health Sciences Ctr at Stony Brook — Stony Brook, New York, United States
- Portland Veterans Adm Med Ctr / Rsch & Education Grp — Portland, Oregon, United States
- Univ of Texas Southwestern Med Ctr of Dallas — Dallas, Texas, United States
- Richmond AIDS Consortium — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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