NV15355C:SAQUINAVIR + 2 NUCLEOSIDE ANTIRETROVIRAL DRUGS IN HIV INFECT

NV15355C：沙奎那韦 2 核苷类抗逆转录病毒药物治疗 HIV 感染

• 批准号: 6309588
• 负责人: NEWTON E HYSLOP
• 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: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6309588
• 关键词: AIDS therapy; HIV infections; antiAIDS agent; clinical research; combination chemotherapy; human subject; human therapy evaluation; nucleosides; saquinavir; virus replication

Analyses in HIV infected patients of the relationship between exposure to saquinavir and laboratory markers of HIV disease activity have shown that increased exposure result in increased suppression of viral replication and increased elevation of CD4 counts in the peripheral blood. The development of a new, soft-gelatin capsule formulation of saquinavir has provided the means to achieve exposures of saquinavir on the order of 8 times that seen with the standard dosing of the currently available hard gelatin capsule formulation without the limitation imposed by the large numbers of capsules needed to achieve high exposures. Available data from volunteers and patients who have taken doses to reach high exposures show that the high exposures are well tolerated. Modeling of the relationship between exposure of saquinavir and the change in viral load over time implies that dosing saquinavir at high doses would provide limited improvement in the antiviral response because the exposure-response curve has flattened. The purpose of this study is to see if adding saquinavir to other treatments for HIV infection are safe and if it adds to the ability of treatments to slow down the growth of HIV.

对艾滋病毒感染患者暴露于沙奎那韦与艾滋病毒疾病活性实验室标记物之间关系的分析表明，暴露增加导致病毒复制抑制增加，外周血中CD4计数升高。一种新的沙奎那韦软明胶胶囊配方的开发提供了一种方法，使沙奎那韦的暴露量达到目前可用的硬明胶胶囊配方标准剂量的8倍，而不受实现高暴露所需的大量胶囊所施加的限制。从服用剂量达到高剂量的志愿者和患者那里获得的现有数据表明，高剂量的剂量是可以耐受的。对沙奎那韦暴露与病毒载量随时间变化之间关系的建模表明，高剂量沙奎那韦对抗病毒反应的改善有限，因为暴露-反应曲线已经变平。这项研究的目的是看看在其他治疗HIV感染的药物中加入沙奎那韦是否安全，以及它是否能增加治疗减缓HIV生长的能力。