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
Ethambutol hydrochloride
+ Clarithromycin
Blood-Borne Infections+20
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 8 locations
Univ of Arizona / Health Science Ctr
Tucson, United StatesOpen Univ of Arizona / Health Science Ctr in Google MapsUniv of Maryland at Baltimore
Baltimore, United StatesUMDNJ - New Jersey Med School / Cooper Hosp
Camden, United StatesAlbany Med College / Division of HIV Medicine A158
Albany, United States