ACTG 254--PHASE II/III STUDY OF AT/AZ AS COMPARED TO TMP/SMX IN CHILDREN

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Pneumocystis carinii pneumonia (PCP) is the most common opportunistic infection reported in HIV-infected children. While trimethoprim-sulfamethoxazole (TMP/SMX) remains the drug of choice for PCP prophylaxis, drug sensitivity may limit its effective use; in addition, the efficacy of the most common alternative therapies-including dapsone and pentamidine has yet to be determined in infants and children. Atovaquone, an oral medication requiring only once daily administration, has demonstrated activity against P. carinii and Toxoplasma gondii, and has been shown to be both safe and with no defined adverse or toxic effects. Primary objectives of this multi-centered, two-armed, double blind, placebo controlled study will be to compare TMP/SMX and AT/AZ in the prevention of serious bacterial infections; determine and compare long-term safety and tolerance; and assess the likelihood of pharmacokinetic interaction between atovaquone and azithromycin in a subset of two to 18 year old patients.