ACTG377--ANTIRETROVIRAL REGIMENS W/ COMBOS OF PROTEASE INHIBITORS

ACTG377--蛋白酶抑制剂组合的抗逆转录病毒治疗方案

• 批准号: 6306322
• 负责人: Stuart E Starr
• 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/6306322
• 关键词: HIV infections; antiAIDS agent; clinical research; clinical trial phase I; combination chemotherapy; human immunodeficiency virus 1; human subject; human therapy evaluation; longitudinal human study; nevirapine; protease inhibitor; ritonavir; virus RNA; virus replication

The primary objectives of this study are to compare the safety, tolerance, virologic effect and immunologic effects of four treatment regimens: d4T, nevirapine, ritonavir (Arm A), d4T, 3TC, nelfinavir (Arm B), d4T, nevirapine, nelfinavir (Arm C) and d4T, 3TC, nevirapine, nelfinavir (Arm D) in HIV-infected children. Secondary objective include evaluation of the response to therapy as measured by growth velocity, changes in neurodevelopmental indices, and HIV disease progression based on time to development of the first new CDC category C diagnosis. Estimates of exposure to study drugs, based on population pharmacokinetic parameters, will be correlated to virologic responses. Lymphocyte proliferation responses to recall mitogens, microbial recall antigens, and HIV antigens will be evaluated across treatment arms and correlated with virologic inhibition. The study has been fully enrolled.

本研究的主要目的是比较四种治疗方案的安全性、耐受性、病毒学效应和免疫学效应：d4T、奈韦拉平、利托那韦（A 组）、d4T、3TC、奈非那韦（B 组）、d4T、奈韦拉平、奈非那韦（ C 组）和 d4T、3TC、奈韦拉平、奈非那韦（D 组）感染艾滋病毒的儿童。 次要目标包括根据生长速度、神经发育指数的变化以及基于第一个新的 CDC C 类诊断的发展时间的 HIV 疾病进展来评估对治疗的反应。 根据群体药代动力学参数估计研究药物的暴露量将与病毒学反应相关。 淋巴细胞对有丝分裂原、微生物回忆抗原和 HIV 抗原的增殖反应将在治疗组中进行评估，并与病毒学抑制相关。 该研究已全部入组。