Dose-escalation, phase 1/11 study of azithromycin and pyrimethamine for the treatment of toxoplasmic encephalitis in AIDS

Jeffrey M. Jacobson, Richard Hafner, Jack Remington, Charles Farthing, Jeanne Holden-Wiltse, Elizabeth M. Bosler, Carol Harris, Dushyantha T. Jayaweera, Clemente Roque, Benjamin J. Luft

Research output: Contribution to journalArticlepeer-review

42 Scopus citations


Objective: To assess the safety, tolerance and activity of increasing doses of azithromycin in combination with pyrimethamine for the treatment of toxoplasmic encephalitis (TE) in patients with AIDS. Design: A phase 1/11 dose-escalation study of oral azithromycin in combination with pyrimethamine. Setting: Eight clinical sites in the United States. Patients: Forty-two adult HIV-infected patients with confirmed or presumed acute TE. Methods: Patients were enrolled into three successive cohorts receiving azithromycin 900, 1200 and 1500mg a day with pyrimethamine as induction therapy. The induction period was 6 weeks followed by 24 weeks of maintenance therapy. Main outcome measures: Patient response was evaluated clinically and radiologically. Results: Of the 30 evaluable patients, 20 (67%) responded to therapy during the induction period. Ten experienced disease progression. Of the 15 patients who received maintenance therapy, seven (47%) relapsed. Six patients discontinued treatment during the induction period as a result of reversible toxicities. Treatment-terminating adverse events occurred most frequently among the patients receiving the 1500 mg dose. Conclusion: The combination of azithromycin (900-1200 mg a day) and pyrimethamine may be useful as an alternative therapy for TE among patients intolerant of sulfonamides and clindamycin, but maintenance therapy with this combination was associated with a high relapse rate. The combination was safe, but low-grade adverse events were common.

Original languageEnglish (US)
Pages (from-to)583-589
Number of pages7
Issue number5
StatePublished - Mar 30 2001


  • AIDS
  • Azithromycin
  • HIV
  • Pyrimethamine
  • Toxoplasmic encephalitis

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology


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