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February 8, 1993

Clarithromycin and Other Antimicrobial Agents in the Treatment of Disseminated Mycobacterium avium Infections in Patients With Acquired Immunodeficiency Syndrome

Arch Intern Med. 1993;153(3):368-372. doi:10.1001/archinte.1993.00410030074010

Background:  Disseminated infection with Mycobacterium avium is common with late-stage acquired immunodeficiency syndrome (AIDS), and no antimicrobial agent has been found to be clearly effective.

Methods:  A multicenter open trial was conducted to assess the antimicrobial activity and clinical efficacy of clarithromycin—a new macrolide antibiotic—against disseminated M avium in 77 patients with late-stage AIDS. Blood cultures were taken at baseline and during treatment; side effects were also evaluated.

Results:  Mycobacterium avium was eradicated from blood cultures in 11 (63%) of 16 evaluable patients receiving daily doses or 500 or 1000 mg, (n=21) and in 45 of 46 (98%) of those receiving 1500 or 2000 mg (n=56). Eradication after 2 months was influenced by continuity of drug treatment; 36 of 42 patients with no relapse had received continuous treatment vs six of 14 patients whose drug treatment had been stopped for 7 days or longer. After 2 to 7 months of treatment, acquired resistance associated with relapse was observed. Drug side effects were elevated liver enzyme levels (26%) and impaired hearing (4%). Concomitant AIDS drugs had no favorable effect on outcome and may have worsened liver toxicity.

Conclusions:  Clarithromycin has bacteriologic efficacy against M avium infection in late-stage AIDS, although drug resistance eventually develops. Further studies are needed to investigate safe, effective concomitant drugs.(Arch Intern Med. 1993;153:368-372)