A randomised, double-blind study of itraconazole versus placebo in the treatment and prevention of oral or oesophageal candidosis in patients with HIV infection.
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 Fifteen patients were withdrawn for a variety of reasons including non-compliance, adverse events and the use of excluded medications.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.
Smith
D
D
Community HIV Research Network, University of New South Wales, Australia.
Midgley
J
J
Gazzard
B
B
D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy* / Q000517:prevention & control; D000328:Adult; D000935:Antifungal Agents / Q000627:therapeutic use*; D002177:Candidiasis / Q000188:drug therapy* / Q000517:prevention & control; D002180:Candidiasis, Oral / Q000188:drug therapy* / Q000517:prevention & control; D004311:Double-Blind Method; D004935:Esophageal Diseases / Q000175:diagnosis / Q000188:drug therapy* / Q000517:prevention & control; D005260:Female; D015658:HIV Infections / Q000150:complications; D006801:Humans; D017964:Itraconazole / Q000627:therapeutic use*; D008297:Male; D015990:Placebo Effect; D010919:Placebos; D016896:Treatment Outcome
D000935:Antifungal Agents; D010919:Placebos; D017964:Itraconazole