CTN 020: Itraconazole, ketoconazole

Study Approach

This was a phase III study, which measures how well a drug works in large groups of people, and was double-blinded (neither doctors nor volunteers knew which therapy volunteers received). Participants were randomly assigned to receive either itraconazole or ketoconazole (200 mg/day), for 14 days if they had oropharyngeal candidiasis, or for 28 days if they had esophageal candidiasis.They were evaluated after one, two and four (for esophageal patients) weeks of therapy, and relapses were compared in a six-week post-treatment follow-up period.

Study Population

One hundred and forty-three patients were randomized in 10 hospitals and clinics in Montreal. Of the 129 eligible patients, 98 had oropharyngeal candidiasis and 31 esophageal infection. CD4 counts and number of previous episodes of oropharyngeal or esophageal candidiasis were the same in both groups.

Results

Oropharyngeal infection was cleared at 21 days in 71% of patients receiving itraconazole and 60% receiving ketoconazole, and esophageal candidiasis was cleared at 41 days in 100% of patients receiving itraconazole and 91% receiving ketoconazole. Marginally significant differences were found between itraconazole and ketoconazole in the rates at which infection cleared. Average rates of infection relapse were not statistically different in the two treatment groups. Side effects were generally mild and not considered drug-related.

Conclusions

Itraconazole is marginally more effective than ketoconazole in treating oropharyngeal and esophageal candidiasis in HIV-positive patients and both drugs appear safe and well-tolerated.