ACTG 366: NOVEL ANTIRETROVIRAL THERAPY IN ANTIRETROVIRAL EXP CHILD

ACTG 366：抗逆转录病毒治疗儿童的新型抗逆转录病毒疗法

• 批准号: 6264294
• 负责人: ELIZABETH G MCFARLAND
• 金额: $ 1.99万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 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/6264294
• 关键词: AIDS therapy; HIV infections; antiAIDS agent; child (0-11); clinical research; clinical trial phase I; combination chemotherapy; drug administration rate /duration; drug screening /evaluation; helper T lymphocyte; human immunodeficiency virus 1; human subject; human therapy evaluation; nevirapine; pediatric AIDS; pharmacokinetics; protease inhibitor; ritonavir; virus RNA; virus load

This trial is designed to evaluate whether four drug combination therapies based on prior antiretroviral experience can maximally decrease viral load and increase CD4 cells. The primary objectives are 1) to determine the proportion of subjects in each Group having reduction in HIV-1 RNA when all antiretroviral agents are changed and at least 2 of the agents are novel and to determine the duration of the reduction; 2) To evaluate the safety and tolerance of these combinations based on clinical and laboratory toxicities; and 3) to determine the steady-state pharmacokinetics of nevirapine, nelfinavir and ritonavir when used in combination with respect to age and treatment group.

该试验旨在评估基于先前抗逆转录病毒经验的四种药物联合疗法是否可以最大程度地降低病毒载量并增加CD4细胞。 主要目标是 1) 确定当所有抗逆转录病毒药物均发生变化且至少 2 种药物为新药物时，每组中 HIV-1 RNA 减少的受试者比例，并确定减少的持续时间； 2) 根据临床和实验室毒性评估这些组合的安全性和耐受性； 3) 确定奈韦拉平、奈非那韦和利托那韦联合使用时相对于年龄和治疗组的稳态药代动力学。