search
Back to results

The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS

Primary Purpose

Mycobacterium Avium-intracellular Infection, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ethambutol hydrochloride
Clarithromycin
Clofazimine
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria Patients must have: History of HIV seropositivity. Disseminated MAC. Positive blood culture for MAC within 4 weeks prior to study entry. Consent of parent or guardian if less than 18 years of age. Ability to complete the study. NOTE: Patients with active opportunistic infections other than dMAC are permitted if dosage and clinical parameters have been stable for 4 weeks prior to enrollment. Exclusion Criteria Concurrent Medication: Excluded: Active therapy with carbamazepine or theophylline, unless investigator agrees to carefully monitor blood levels. Active therapy with investigational drugs other than treatment for HIV disease, except with approval of the sponsor. Concomitant terfenadine (Seldane or Seldane-D) or astemizole (Hismanal). Amikacin. Azithromycin. Capreomycin. Ciprofloxacin. Cycloserine. Ethionamide. Gentamicin. Kanamycin. Levofloxacin. Lomefloxacin. Ofloxacin. Rifampin. Rifabutin. Sparfloxacin. Streptomycin. Any other aminoglycosides, quinolones, and macrolides. Patients with the following prior conditions are excluded: History of allergy or hypersensitivity to macrolides, ethambutol, or clofazimine. Prior Medication: Excluded: Other antimycobacterials, including aminoglycosides, ansamycin (rifabutin), other macrolides (such as clindamycin), quinolones, and rifampin, between screening and study entry. Clarithromycin or azithromycin as prophylaxis or treatment (for any cause) for more than 14 days cumulative within the past 2 months.

Sites / Locations

  • Kaiser Permanente Med Ctr
  • UCD Med Ctr
  • Kaiser Permanente Med Ctr
  • Santa Clara Valley Med Ctr
  • George Washington Univ Med Ctr
  • Dr Margaret Fischel
  • Saint Joseph's Hosp / Infectious Disease Rsch Institute
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Tulane Univ Med School
  • Johns Hopkins Univ School of Medicine
  • Beth Israel Med Ctr
  • Mount Sinai Med Ctr
  • Univ of North Carolina School of Medicine
  • Dr Stephen Hauptman
  • Vanderbilt Univ School of Medicine
  • Univ of Texas Southwestern Med Ctr of Dallas
  • Houston Veterans Administration Med Ctr
  • Dr Javier Morales

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
January 15, 2015
Sponsor
Abbott
search

1. Study Identification

Unique Protocol Identification Number
NCT00002331
Brief Title
The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS
Official Title
A Randomized Open-Label Study of the Tolerability and Efficacy of Clarithromycin and Ethambutol in Combination With or Without Clofazimine for the Treatment of Disseminated MAC (dMAC) in Patients With AIDS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
January 1994 (undefined)
Primary Completion Date
March 1995 (Actual)
Study Completion Date
March 1995 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

Brief Summary
PRIMARY: To assess the tolerability of the combination regimen of clarithromycin plus ethambutol with or without clofazimine in patients with disseminated Mycobacterium avium Complex (dMAC). SECONDARY: To determine the proportion of patients achieving a sterile blood culture along with the time required to achieve it. To determine the duration of bacteriological response, defined as length of time that blood cultures remain sterile.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients must have: History of HIV seropositivity. Disseminated MAC. Positive blood culture for MAC within 4 weeks prior to study entry. Consent of parent or guardian if less than 18 years of age. Ability to complete the study. NOTE: Patients with active opportunistic infections other than dMAC are permitted if dosage and clinical parameters have been stable for 4 weeks prior to enrollment. Exclusion Criteria Concurrent Medication: Excluded: Active therapy with carbamazepine or theophylline, unless investigator agrees to carefully monitor blood levels. Active therapy with investigational drugs other than treatment for HIV disease, except with approval of the sponsor. Concomitant terfenadine (Seldane or Seldane-D) or astemizole (Hismanal). Amikacin. Azithromycin. Capreomycin. Ciprofloxacin. Cycloserine. Ethionamide. Gentamicin. Kanamycin. Levofloxacin. Lomefloxacin. Ofloxacin. Rifampin. Rifabutin. Sparfloxacin. Streptomycin. Any other aminoglycosides, quinolones, and macrolides. Patients with the following prior conditions are excluded: History of allergy or hypersensitivity to macrolides, ethambutol, or clofazimine. Prior Medication: Excluded: Other antimycobacterials, including aminoglycosides, ansamycin (rifabutin), other macrolides (such as clindamycin), quinolones, and rifampin, between screening and study entry. Clarithromycin or azithromycin as prophylaxis or treatment (for any cause) for more than 14 days cumulative within the past 2 months.
Facility Information:
Facility Name
Kaiser Permanente Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
UCD Med Ctr
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kaiser Permanente Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Santa Clara Valley Med Ctr
City
San Jose
State/Province
California
ZIP/Postal Code
951282699
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Dr Margaret Fischel
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Saint Joseph's Hosp / Infectious Disease Rsch Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Tulane Univ Med School
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
701122699
Country
United States
Facility Name
Johns Hopkins Univ School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Univ of North Carolina School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
275997215
Country
United States
Facility Name
Dr Stephen Hauptman
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Vanderbilt Univ School of Medicine
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
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
Houston Veterans Administration Med Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Dr Javier Morales
City
Condado San Juan
ZIP/Postal Code
00907
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
9147422
Citation
Chaisson RE, Keiser P, Pierce M, Fessel WJ, Ruskin J, Lahart C, Benson CA, Meek K, Siepman N, Craft JC. Clarithromycin and ethambutol with or without clofazimine for the treatment of bacteremic Mycobacterium avium complex disease in patients with HIV infection. AIDS. 1997 Mar;11(3):311-7. doi: 10.1097/00002030-199703110-00008.
Results Reference
background

Learn more about this trial

The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS

We'll reach out to this number within 24 hrs