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，适用于具有高度抗逆转录病毒经验的艾滋病毒感染儿童，这些儿童患有快速进展或晚期艾滋病毒疾病，目前的抗逆转录病毒治疗对这些儿童无效。该方案评估了逆转录酶抑制剂和蛋白酶抑制剂类别的抗逆转录病毒药物在降低病毒载量方面的新组合，并评估了这些组合的安全性和药代动力学。这项研究规定，每个受试者必须总共接受4种药物，其中至少2种是针对个别患者的新药物。疗程为52周，可选择延长至100周。这项多中心研究目前已接近应计。费城儿童医院的一名患者已经完成了研究要求，没有不良反应。

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.