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

Launched by ABBOTT · Aug 30, 2001

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility 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.