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: 6264774
• 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: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6264774
• 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 open to accrual. To date, 153 patients have been enrolled at all centers (one at CHOP). The target accrual goal is 200 patients nationwide. No preliminary data are available.

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。 该研究规定，每例受试者必须接受总共4种药物，其中至少2种对于个体患者来说是新颖的。 治疗持续时间为52周，可选择延长至100周。本多中心研究目前开放招募。 迄今为止，所有临床试验机构已入组153例患者（1例在CHOP）。 目标招募目标为全国200例患者。 没有初步数据。