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

Completed · Not applicable

Conditions studied: Mycobacterium Avium-intracellular Infection, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002331

Run by

Abbott

Starts

1994-01-01

Expected to finish

1995-03-01

Last updated by the study team

2015-01-16

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

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

Full record on ClinicalTrials.gov

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