The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS
Information provided by (Responsible Party)
First received: November 2, 1999
Last updated: January 15, 2015
Last Verified: February 2009
History of Changes
PRIMARY: To assess the tolerability of the combination regimen of clarithromycin plus
ethambutol with or without clofazimine in patients with disseminated Mycobacterium avium
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.
Mycobacterium Avium-intracellular Infection
Drug : Ethambutol hydrochloride
Drug : Clarithromycin
Drug : Clofazimine
Primary Purpose: Treatment
|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|
Further study details as provided by Abbott:
|Study Start Date:||January 1994|
|Study Completion Date:||March 1995|
|Primary Completion Date:||March 1995 (Final data collection date for primary outcome measure)|
|Ages Eligible for Study:||13 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- Patients with active opportunistic infections other than dMAC are permitted if dosage and clinical parameters have been stable for 4 weeks prior to enrollment.
- 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).
- Any other aminoglycosides, quinolones, and macrolides.
- 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
Patients with the following prior conditions are excluded:
History of allergy or hypersensitivity to macrolides, ethambutol, or clofazimine.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002331
Locations Show More
|United States, California|
|Kaiser Permanente Med Ctr|
|Los Angeles, California, United States, 90027|
|UCD Med Ctr|
|Sacramento, California, United States, 95817|
|Kaiser Permanente Med Ctr|
|San Francisco, California, United States, 94115|
|Santa Clara Valley Med Ctr|
|San Jose, California, United States, 951282699|
|United States, District of Columbia|
|George Washington Univ Med Ctr|
|Washington, District of Columbia, United States, 20037|
|United States, Florida|
|Dr Margaret Fischel|
|Miami, Florida, United States, 33136|
|Saint Joseph's Hosp / Infectious Disease Rsch Institute|
|Tampa, Florida, United States, 33614|
|United States, Illinois|
|Rush Presbyterian - Saint Luke's Med Ctr|
|Chicago, Illinois, United States, 60612|
|United States, Louisiana|
|Tulane Univ Med School|
|New Orleans, Louisiana, United States, 701122699|
|United States, Maryland|
|Johns Hopkins Univ School of Medicine|
|Baltimore, Maryland, United States, 21205|
|United States, New York|
|Beth Israel Med Ctr|
|New York, New York, United States, 10003|
|Mount Sinai Med Ctr|
|New York, New York, United States, 10029|
|United States, North Carolina|
|Univ of North Carolina School of Medicine|
|Chapel Hill, North Carolina, United States, 275997215|
|United States, Pennsylvania|
|Dr Stephen Hauptman|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Tennessee|
|Vanderbilt Univ School of Medicine|
|Nashville, Tennessee, United States, 37212|
|United States, Texas|
|Univ of Texas Southwestern Med Ctr of Dallas|
|Dallas, Texas, United States, 75235|
|Houston Veterans Administration Med Ctr|
|Houston, Texas, United States, 77030|
|Dr Javier Morales|
|Condado San Juan, Puerto Rico, 00907|
Sponsors and CollaboratorsAbbott
|ClinicalTrials.gov Identifier:||NCT00002331 History of Changes|
|Other Study ID Numbers:||214A|
|Study First Received:||November 2, 1999|
|Last Updated:||January 15, 2015|
Keywords provided by Abbott:Mycobacterium avium-intracellular Infection
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
Mycobacterium avium-intracellulare Infection
ClinicalTrials.gov processed this data on March 21, 2018
This information is provided by ClinicalTrials.gov.