NV15355C:SAQUINAVIR + 2 NUCLEOSIDE ANTIRETROVIRAL DRUGS IN HIV INFECT

对HIV感染患者暴露于沙奎那韦与HIV疾病活动性的实验室标志物之间关系的分析表明，暴露增加导致病毒复制抑制增加和外周血中CD4计数升高。 沙奎那韦的新的软明胶胶囊制剂的开发提供了使沙奎那韦的暴露量达到目前可用的硬明胶胶囊制剂的标准剂量的8倍的数量级的手段，而没有实现高暴露量所需的大量胶囊所施加的限制。 从志愿者和患者获得的数据表明，高剂量暴露耐受性良好。 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，高剂量沙奎那韦给药对抗病毒反应的改善有限，因为抗病毒反应曲线已经变平。 这项研究的目的是看看在其他治疗艾滋病毒感染的方法中加入沙奎那韦是否安全，以及它是否增加了治疗减缓艾滋病毒生长的能力。

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.