P1030: A PHASE I/II STUDY OF LOPINAVIR/RITONAVIR IN HIV-1 INFECTED INFANTS < 6

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。洛比那韦是一种有效的蛋白酶抑制剂，即使在低剂量的利托那韦(RTV)促进药代动力学时也很敏感，从而在整个剂量区间内提供治疗性LPV浓度。洛匹那韦/利托那韦在成人和6个月大的儿童的临床试验中显示出显著的抗病毒活性和耐受性。这项研究的主要目的是1)评估6个月大的HIV感染婴儿和6个月大的艾滋病毒感染者的LPV/RTV(LPV/RTV)剂量要求，这些婴儿和6个月大的婴儿提供与已被证明在较大的儿童和成人中安全有效的全身暴露相似的剂量；2)确定作为包括核苷类似物在内的组合方案的一部分在HIV感染婴儿和6个月大的婴儿和6个月大的婴儿中开始LPV/RTV的短期和长期安全性和耐受性。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Lopinavir is a potent protease inhibitor that is sensitive to pharmacokinetic enhancement by ritonavir (RTV) even at low RTV doses, thus providing therapeutic LPV concentrations over the entire dose interval. Lopinavir/ritonavir has shown significant antiviral activity and tolerability in clinical trials in adults and children > 6 months of age. The primary objectives of this study are to 1) evaluate lopinavir/ritonavir (LPV/RTV) dose requirements for HIV-infected infants < 6 months of age that provide systemic exposure similar to that which has been shown to be safe and effective in older children and adults and 2) determine the short-term and long-term safety and tolerance of LPV/RTV initiated in HIV-infected infants < 6 months of age as part of a combination regimen including nucleoside analogs.