Background: Dapsone is an alternative drug for prophylaxis of Pneumocystis carinii pneumonia (PCP), but there are few data about its toxicity or efficacy in HIV-infected children.

Methods: This was a randomized, open-label, multicenter study of daily vs. weekly dapsone in HIV-infected children intolerant to trimethoprim/ sulfamethoxazole (T/S) who required PCP prophylaxis. 94 children were randomized to 1 mg/kg daily (later 2 mg/kg) or 4 mg/kg weekly of oral dapsone. Hematologic, hepatic and clinical toxicities, survival, and the incidence of laboratory-proven PCP were monitored, and steady-state pharmocokinetic (PK) studies were performed.

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