NV15355C:SAQUINAVIR + 2 NUCLEOSIDE ANTIRETROVIRAL DRUGS IN HIV INFECT

对艾滋病毒感染患者接触沙奎那韦与艾滋病毒疾病活动实验室标志之间的关系的分析表明，增加暴露导致病毒复制受到更大的抑制，外周血中的CD4计数增加。一种新的沙奎那韦软胶囊配方的开发提供了实现沙奎那韦曝光量的手段，其暴露量是目前可获得的硬胶胶囊配方的标准剂量的8倍，而不受实现高曝光量所需的大量胶囊的限制。来自志愿者和服用剂量以达到高暴露水平的患者的现有数据显示，高暴露水平的耐受性很好。对沙奎那韦的暴露与病毒载量随时间变化之间的关系的模拟表明，高剂量的沙奎那韦对抗病毒反应的改善有限，因为暴露-反应曲线变平了。这项研究的目的是看看在其他治疗艾滋病毒感染的药物中加入沙奎那韦是否安全，以及它是否增加了治疗方法减缓艾滋病毒增长的能力。

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.