Itraconazole maintenance treatment for histoplasmosis in AIDS: A prospective, multicenter trial

Frederick M. Hecht, Joseph Wheat, Ann H. Korzun, Richard Hafner, Kenneth J. Skahan, Robert Larsen, Maria Theresa Limjoco, Margaret Simpson, Debra Schneider, Michael C. Keefer, Rebecca Clark, Kwan Kew Lai, Jeffrey M. Jacobson, Kathleen Squires, John A. Bartlett, William Powderly

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67 Scopus citations


Purpose: To study the efficacy and safety of maintenance treatment with itraconazole for disseminated histoplasmosis in patients with AIDS. Patients and Methods: This was a prospective, multicenter, open-label study conducted at university-based hospitals participating in the AIDS Clinical Trial Group (ACTG). Forty-six AIDS patients with mild to moderate disseminated histoplasmosis who had successfully completed 12 weeks of induction treatment with itraconazole were treated with itraconazole, 200 mg once daily (42 patients) or 400 mg once daily (4 patients). Patients were followed at monthly intervals with clinical and laboratory assessment for relapse or toxicity. Primary outcome measures were relapse of histoplasmosis and survival. Secondary outcome measures included drag-limiting toxicity and changes in serum and urine Histoplasma polysaccharaide antigen (HPA) levels. Results: Two patients relapsed during a median follow-up period of 87 weeks. The 1-year relapse-free rate was estimated to be 95.3% (95% CI, 85.3%- 99.7%). One relapse may have been related to poor adherence to treatment and the second to concurrent administration of rifampin. From the start of maintenance treatment, the estimated 1-year survival rate was 73.0% (95% CI, 67.5%-77.9%). Five patients discontinued treatment because of suspected drug toxicity, three of whom had possible or probable hepatotoxicity. Median serum and urine HPA levels declined significantly during treatment. The only patient in whom antigen levels rose >2 U developed clinical relapse 1 week later; antigen levels were unavailable in the other relapsing patient. Conclusions: Itraconazole, 200 mg daily, is effective in preventing relapse of disseminated histoplasmosis in patients with AIDS. It is generally well tolerated, but clinicians should be alert for drug interactions and possible hepatotoxicity.

Original languageEnglish
Pages (from-to)100-107
Number of pages8
JournalJournal of Acquired Immune Deficiency Syndromes and Human Retrovirology
Issue number2
StatePublished - Oct 1 1997


  • AIDS
  • Clinical trial
  • Histoplasmosis
  • Itraconazole


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