SAFETY & EFFICACY OF NELFINAVIR ADDED TO BACKGROUND ANTIRETROVIRAL NU

安全

• 批准号: 6265767
• 负责人: CHERYL L BESCH
• 金额: $ 1.12万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-07-19 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6265767
• 关键词: AIDS therapy; HIV infections; antiAIDS agent; clinical research; combination chemotherapy; drug screening /evaluation; human subject; human therapy evaluation; pathologic process; protease inhibitor; ritonavir

The purpose of the Nelfinavir versus Ritonavir Protocol is to determine whether a strategy of adding nelfinavir (NFV) to background antiretroviral nucleoside therapy is equivalent, in terms of delaying disease progression events or death, to the strategy of adding ritonavir (RTV) to background antiretroviral nucleoside therapy in patients with CD4+ cells counts < 100/mm3. The protocol document provides the background and rationale, the study design, the eligibility requirements, the sample size and the assumptions used to arrive at the sample size, the methodology for implementation of the study, and the plan for analysis of the data. This protocol is being carried out with the support of the NIAID and Agouron Pharmaceuticals, Inc. This study will be an open-label trial in which eligible patients will be randomized either to NFV plus background AR nucleoside therapy or to RTV plus background AR nucleoside therapy. Patients will be allowed to cross over to the alternate protease inhibitor if they develop a disease progression event or a significant intolerance to the assigned agent.

奈非那韦与利托那韦方案的目的是确定在CD 4+细胞计数< 100/mm 3的患者中，在背景抗逆转录病毒核苷治疗中添加奈非那韦（NFV）的策略与在背景抗逆转录病毒核苷治疗中添加利托那韦（RTV）的策略在延迟疾病进展事件或死亡方面是否等效。 方案文件提供了背景和依据、研究设计、合格性要求、样本量和用于得出样本量的假设、研究实施方法和数据分析计划。 本方案在NIAID和Agouron Pharmaceuticals，Inc.的支持下实施。本研究将是一项开放标签试验，合格患者将随机接受NFV+背景AR核苷治疗或RTV+背景AR核苷治疗。如果患者发生疾病进展事件或对指定药物显著不耐受，则允许患者交叉使用替代蛋白酶抑制剂。