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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002331
Other study ID # 214A
Secondary ID M93-069
Status Completed
Phase N/A
First received November 2, 1999
Last updated January 15, 2015
Start date January 1994
Est. completion date March 1995

Study information

Verified date February 2009
Source Abbott
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date March 1995
Est. primary completion date March 1995
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ethambutol hydrochloride

Clarithromycin

Clofazimine


Locations

Country Name City State
Puerto Rico Dr Javier Morales Condado San Juan
United States Johns Hopkins Univ School of Medicine Baltimore Maryland
United States Univ of North Carolina School of Medicine Chapel Hill North Carolina
United States Rush Presbyterian - Saint Luke's Med Ctr Chicago Illinois
United States Univ of Texas Southwestern Med Ctr of Dallas Dallas Texas
United States Houston Veterans Administration Med Ctr Houston Texas
United States Kaiser Permanente Med Ctr Los Angeles California
United States Dr Margaret Fischel Miami Florida
United States Vanderbilt Univ School of Medicine Nashville Tennessee
United States Tulane Univ Med School New Orleans Louisiana
United States Beth Israel Med Ctr New York New York
United States Mount Sinai Med Ctr New York New York
United States Dr Stephen Hauptman Philadelphia Pennsylvania
United States UCD Med Ctr Sacramento California
United States Kaiser Permanente Med Ctr San Francisco California
United States Santa Clara Valley Med Ctr San Jose California
United States Saint Joseph's Hosp / Infectious Disease Rsch Institute Tampa Florida
United States George Washington Univ Med Ctr Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (1)

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. — View Citation

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