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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

Author Affiliations

From the Pulmonary Department (Dr Dautzenberg) and Bacteriology-Virology Laboratories (Dr Grosset), Groupe Hospitalier Pitié-Salpêtrière, Paris, France; Department of Clinical Immunology and Transplantation, Hôpital E. Herriot, Lyon, France (Dr Saint Marc); Department of Infectious Disease, Hôpital Saint Antoine, Paris (Dr Meyohas); Department of Infectious Disease, Hôpital Pasteur, Paris (Dr Eliaszewitch); Department of Infectious Disease, C. M. C. de Bligny, Briis/Forges, France (Dr Haniez); Department of Infectious Disease, Hôpital Pellegrin, Bordeaux, France (Dr Rogues); Department of Infectious Disease, Hôpital Saint Pierre, Brussels, Belgium (Dr De Wit); Hepatitis and AIDS Unit, Hôpital Hôtel Dieu, Lyon (Dr Cotte); and Abbott France, Rungis (Dr Chauvin).

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)