ACTG 382--PHASE I/II, OPEN LABEL, AUC CONTROLLED STUDY DMP 266

ACTG 382--I/II 期、开放标签、AUC 对照研究 DMP 266

• 批准号: 6441962
• 负责人: Kenneth McIntosh
• 金额: $ 2.88万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-12-01 至 2001-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6441962
• 关键词: AIDS therapy; HIV infections; antiAIDS agent; child (0-11); clinical research; clinical trial phase I; combination chemotherapy; dosage; drug screening /evaluation; human subject; human therapy evaluation; pediatric AIDS; pharmacokinetics; protease inhibitor; reverse transcriptase inhibitors; virus replication

ACTG 382 is an open-label, AUC-controlled, multicenter study. All subjects will receive DMP 266 and nelfinavir. DMP 266 is a non-nucleoside reverse transcriptase inhibitor (NNRTI) which, in vitro, inhibits HIV production from infected cells. Dosage guidelines for children will be developed following analysis of the plasma level data and the DMP 266 dose used to obtain the target AUC. The primary objectives of the study are 1) to determine the dosing regimen of DMP 266 in combination with nelfinavir in children; and 2) to study the safety profile of DMP 266 in combination with nelfinavir in children.

ACTG 382 是一项开放标签、AUC 对照、多中心研究。所有受试者将接受 DMP 266 和奈非那韦。 DMP 266 是一种非核苷逆转录酶抑制剂 (NNRTI)，在体外可抑制受感染细胞产生 HIV。在分析血浆水平数据和用于获得目标 AUC 的 DMP 266 剂量后，将制定儿童剂量指南。该研究的主要目标是 1) 确定 DMP 266 与奈非那韦联合治疗儿童的给药方案； 2) 研究 DMP 266 与奈非那韦联合治疗儿童的安全性。