ACTG366--4 DRUG COMBO THERAPIES BASED ON ANTIRETROVIRAL EXP IN CHILD W/ HIV

ACTG 366是一项I/II期、开放标签研究，采用管理算法设计，用于目前抗逆转录病毒治疗失败的具有高度抗逆转录病毒经验的HIV感染儿童，这些儿童患有快速进展或晚期HIV疾病。本方案评价了逆转录酶抑制剂和蛋白酶抑制剂类抗逆转录病毒药物的新型组合在降低病毒载量方面的作用，并评价了这些组合的安全性和药代动力学。本研究规定，每例受试者必须接受总共4种药物，其中至少2种药物是个体患者的新型药物。治疗持续时间为52周，可选择延长至100周。本多中心研究目前已停止招募。 费城儿童医院的一名患者已完成研究要求，无不良事件。

ACTG 366 is a phase I/II, open-label study with a management algorithm design for highly antiretroviral-experienced, HIV-infected children with rapidly progressive or advanced HIV disease for whom current antiretroviral therapy is failing. This protocol evaluates novel combinations of antiretroviral drugs of the reverse transcriptase inhibitor and protease inhibitor classes in reducing viral load, and evaluates the safety and pharmacokinetics of these combinations. The study stipulates that each subject must receive a total of 4 agents, at least 2 of which are novel for the individual patient. The treatment duration is 52 weeks with an option for extension to 100 weeks. This multicenter study is currently closed to accrual . One patient at The Children's Hospital of Philadelphia has completed study requirements with no adverse events.