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

ACTG366--4 基于 HIV 儿童抗逆转录病毒实验的药物组合疗法

• 批准号: 6306335
• 负责人: RICHARD RUTSTEIN
• 金额: $ 0.06万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2001-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6306335
• 关键词: AIDS therapy; HIV infections; antiAIDS agent; clinical research; clinical trial phase I; combination chemotherapy; computer assisted patient care; drug screening /evaluation; health services research tag; human subject; human therapy evaluation; middle childhood (6-11); pathologic process; pediatric AIDS; pharmacokinetics; preschool child (1-5); protease inhibitor; reverse transcriptase inhibitors; virus load

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.

ACTG 366 是一项 I/II 期、开放标签研究，其管理算法设计针对的是具有丰富抗逆转录病毒治疗经验、患有快速进展或晚期 HIV 疾病且当前抗逆转录病毒治疗无效的 HIV 感染儿童。该方案评估逆转录酶抑制剂和蛋白酶抑制剂类抗逆转录病毒药物在减少病毒载量方面的新型组合，并评估这些组合的安全性和药代动力学。该研究规定，每个受试者必须接受总共 4 种药物，其中至少有 2 种药物对于个别患者来说是新颖的。治疗持续时间为 52 周，可以选择延长至 100 周。这项多中心研究目前已停止应计。 费城儿童医院的一名患者已完成研究要求，没有出现任何不良事件。