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