A randomised, double-blind study of itraconazole versus placebo in the treatment and prevention of oral or oesophageal candidosis in patients with HIV infection

Int J Clin Pract. Jul-Aug 1999;53(5):349-52.


HIV-infected patients presenting with oral or oesophageal candidosis were randomised to four weeks treatment with itraconazole 200 mg, followed by itraconazole or matching placebo for a prophylaxis phase of 24 weeks. Clinical and mycological evidence of candidosis infection was assessed on a four-weekly basis. Seventy patients were enrolled, of whom 50 completed 28 days of itraconazole therapy; 74% (37 patients) were clinically cured and 40% were also mycologically cured. Fifteen patients were withdrawn for a variety of reasons including non-compliance, adverse events and the use of excluded medications. Forty-four patients were enrolled in the prophylactic phase. There were significantly more relapses of candidosis, and time to candidosis was significantly shorter in the placebo group than in the itraconazole treated group (p = 0.0001). Itraconazole 200 mg daily is effective and well tolerated for the treatment and prevention of oral and oesophageal candidosis in HIV-infected patients.

Publication types

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

MeSH terms

  • AIDS-Related Opportunistic Infections / drug therapy*
  • AIDS-Related Opportunistic Infections / prevention & control
  • Adult
  • Antifungal Agents / therapeutic use*
  • Candidiasis / drug therapy*
  • Candidiasis / prevention & control
  • Candidiasis, Oral / drug therapy*
  • Candidiasis, Oral / prevention & control
  • Double-Blind Method
  • Esophageal Diseases / diagnosis
  • Esophageal Diseases / drug therapy*
  • Esophageal Diseases / prevention & control
  • Female
  • HIV Infections / complications
  • Humans
  • Itraconazole / therapeutic use*
  • Male
  • Placebo Effect
  • Placebos
  • Treatment Outcome


  • Antifungal Agents
  • Placebos
  • Itraconazole