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 start date: January 1, 1994

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.