Randomized Trial of Itraconazole Oral Solution for Oropharyngeal Candidiasis in HIV/AIDS Patients

Am J Med. 1998 Jan;104(1):33-9. doi: 10.1016/s0002-9343(97)00307-0.


Purpose: Oropharyngeal candidasis (thrush) is the most common opportunistic infection in individuals who are positive for the human immunodeficiency virus (HIV) and those who have progressed to AIDS. Itraconazole has a broad in vitro spectrum of activity, including a wide variety of Candida species. Our study determined the relative efficacy of a new oral solution formulation of itraconazole and fluconazole tablets in the treatment of oropharyngeal candidiasis.

Patients and methods: This was a prospective randomized, third-party-blind, multicenter trial conducted at 12 centers in the United States. One hundred seventy-nine HIV-positive patients with mycologically documented oropharyngeal candidiasis were treated with itraconazole oral solution 200 mg/ day for 7 or 14 days, or fluconazole tablets 100 mg/day for 14 days. Severity of disease was scored clinically before treatment and at clinical evaluations on days 3, 7, 14, 21, 35, and 42. Semi-quantitative cultures of mouth washings were also obtained on these days.

Results: Both 14-day and 7-day regimens of itraconazole oral solution were equivalent to fluconazole for most efficacy parameters. The clinical response rate was 97% after 14 days of itraconazole and 87% after 14 days of fluconazole. Itraconazole oral solution given for 7 days was also equivalent to fluconazole treatment for 14 days. Approximately one half of patients in all three groups relapsed by 1 month after completion of treatment. There were few adverse reactions to either drug.

Conclusion: Itraconazole oral solution is well tolerated and offers an alternative at least as effective as fluconazole in the treatment of oropharyngeal candidiasis.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • AIDS-Related Opportunistic Infections / drug therapy*
  • AIDS-Related Opportunistic Infections / pathology
  • Administration, Oral
  • Adult
  • Aged
  • Antifungal Agents / administration & dosage
  • Antifungal Agents / therapeutic use*
  • Candidiasis, Oral / drug therapy*
  • Candidiasis, Oral / pathology
  • Candidiasis, Oral / virology
  • Disease-Free Survival
  • Drug Administration Schedule
  • Female
  • Humans
  • Itraconazole / administration & dosage
  • Itraconazole / therapeutic use*
  • Male
  • Middle Aged
  • Pharyngeal Diseases / drug therapy
  • Pharyngeal Diseases / pathology
  • Pharyngeal Diseases / virology
  • Severity of Illness Index
  • Solutions
  • Time Factors
  • Treatment Outcome


  • Antifungal Agents
  • Solutions
  • Itraconazole