Completed

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

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What is being tested

Ethambutol hydrochloride

+ Clarithromycin

Drug
Who is being recruted

Blood-Borne Infections+20

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 31, 2012
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 31, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesActinomycetales InfectionsBacterial Infections and MycosesBacterial InfectionsCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMycobacterium InfectionsMycobacterium Infections, NontuberculousRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsGram-Positive Bacterial InfectionsAcquired Immunodeficiency SyndromeMycobacterium avium-intracellulare InfectionHIV Infections

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 Maps

Univ of Maryland at Baltimore

Baltimore, United States

UMDNJ - New Jersey Med School / Cooper Hosp

Camden, United States

Albany Med College / Division of HIV Medicine A158

Albany, United States
Completed8 Study Centers