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 r andomised to four weeks treatment with itraconazole 200 mg, followed by itr aconazole or matching placebo for a prophylaxis phase of 24 weeks. Clinical and mycological evidence of candidosis infection was assessed on a four-we ekly 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 Fifteen patients were withdrawn for a variety of reasons including non-compliance, adverse events and the use of excluded m edications. Forty-four patients were enrolled in the prophylactic phase. Th ere were significantly more relapses of candidosis, and time to candidosis was significantly shorter in the placebo group than in the itraconazole tre ated group (p=0.0001). Itraconazole 200 mg daily is effective and well tole rated for the treatment and prevention of oral and oesophageal candidosis i n HIV-infected patients.