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

卡氏肺孢子虫肺炎（PCP）是艾滋病毒感染儿童中最常见的机会性感染。虽然甲氧苄啶-磺胺甲恶唑（TMP/SMX）仍然是预防PCP的首选药物，但药物敏感性可能会限制其有效使用;此外，最常见的替代疗法（包括氨苯砜和喷他脒）在婴儿和儿童中的疗效尚未确定。阿托伐醌是一种口服药物，每天只需服用一次，已证明对卡氏疟原虫和刚地弓形虫具有活性，并且已被证明是安全的，没有明确的不良反应或毒性作用。这项多中心、双组、双盲、安慰剂对照研究的主要目的是比较TMP/SMX和AT/AZ在预防严重细菌感染方面的作用;确定和比较长期安全性和耐受性;并评估阿托伐醌和阿奇霉素在2至18岁患者亚组中药代动力学相互作用的可能性。

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.