The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mycobacterium Avium-Intracellulare Infection; HIV Infections
Intervention: Ethambutol hydrochloride (Drug); Clarithromycin (Drug); Clofazimine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Abbott
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.
Clinical Details
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 design: Treatment, Efficacy Study
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Dr Javier Morales, Condado San Juan 00907, Puerto Rico
UCD Med Ctr, Sacramento, California 95817, United States
Santa Clara Valley Med Ctr, San Jose, California 951282699, United States
Kaiser Permanente Med Ctr, Los Angeles, California 90027, United States
Kaiser Permanente Med Ctr, San Francisco, California 94115, United States
George Washington Univ Med Ctr, Washington, District of Columbia 20037, United States
Dr Margaret Fischel, Miami, Florida 33136, United States
Saint Joseph's Hosp / Infectious Disease Rsch Institute, Tampa, Florida 33614, United States
Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States
Tulane Univ Med School, New Orleans, Louisiana 701122699, United States
Johns Hopkins Univ School of Medicine, Baltimore, Maryland 21205, United States
Beth Israel Med Ctr, New York, New York 10003, United States
Mount Sinai Med Ctr, New York, New York 10029, United States
Univ of North Carolina School of Medicine, Chapel Hill, North Carolina 275997215, United States
Dr Stephen Hauptman, Philadelphia, Pennsylvania 19107, United States
Vanderbilt Univ School of Medicine, Nashville, Tennessee 37212, United States
Houston Veterans Administration Med Ctr, Houston, Texas 77030, United States
Univ of Texas Southwestern Med Ctr of Dallas, Dallas, Texas 75235, United States
Additional Information
Related publications: 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.
Last updated: June 23, 2005
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