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

Primary Purpose

Mycobacterium Avium-intracellulare Infection, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ethambutol hydrochloride
Clarithromycin
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mycobacterium Avium-intracellulare Infection focused on measuring Mycobacterium avium-intracellulare Infection, Drug Therapy, Combination, Ethambutol, Acquired Immunodeficiency Syndrome, Clarithromycin

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Arizona / Health Science Ctr
  • Univ of Maryland at Baltimore
  • UMDNJ - New Jersey Med School / Cooper Hosp
  • Albany Med College / Division of HIV Medicine A158
  • SUNY / Health Sciences Ctr at Stony Brook
  • Portland Veterans Adm Med Ctr / Rsch & Education Grp
  • Univ of Texas Southwestern Med Ctr of Dallas
  • Richmond AIDS Consortium

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 29, 2012
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00001039
Brief Title
Evaluation of Treatment for Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycobacterium Avium-intracellulare Infection, HIV Infections
Keywords
Mycobacterium avium-intracellulare Infection, Drug Therapy, Combination, Ethambutol, Acquired Immunodeficiency Syndrome, Clarithromycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
24 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ethambutol hydrochloride
Intervention Type
Drug
Intervention Name(s)
Clarithromycin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafner R
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Drusano G
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Arizona / Health Science Ctr
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Univ of Maryland at Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
UMDNJ - New Jersey Med School / Cooper Hosp
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Albany Med College / Division of HIV Medicine A158
City
Albany
State/Province
New York
ZIP/Postal Code
122083479
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948153
Country
United States
Facility Name
Portland Veterans Adm Med Ctr / Rsch & Education Grp
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Richmond AIDS Consortium
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States

12. IPD Sharing Statement

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

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