PACTG P1038: HIGH DOSE LOPINAVIR/RITONAVIR WITH OR WITHOUT SAQUINAVIR IN HIV PTS

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。PA CTG P1038是一项大剂量洛匹那韦/利托那韦（LPV/r）的I/II期开放标签研究，旨在评估LPV/r联合或不联合沙奎那韦（SQV）在HIV感染儿童和青少年中的安全性、耐受性和药代动力学，这些儿童和青少年之前至少有6个月的PI经历，并且目前抗逆转录病毒治疗失败（血浆HIV RNA 5000拷贝/mL）。本研究假设，剂量强化不仅有助于克服耐药性，而且以一种类似于癌症的方式，将导致更大的抑制率，从而最大限度地提高病毒抑制的程度和持久性。鉴于大多数感染艾滋病毒的儿童可获得的治疗选择有限，这是一个应加以探讨的选择。该研究将招募48名年龄在2至18岁之间的受试者。受试者将通过同时进行NNRTI治疗进行分层，受试者将从初始LPV/r剂量开始治疗48周。

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. PA CTG P1038 is a Phase I/II, open label study of high dose lopinavir/ritonavir (LPV/r) to assess the safety, tolerability, and pharmacokinetics of LPV/r with or without saquinavir (SQV) in HIV-infected children and adolescents who have at least six months of prior PI experience and are failing their current antiretroviral therapy (plasma HIV RNA 5000 copies/mL). This study hypothesizes that dose intensification will not only aid in overcoming resistance but in a manner analogous to cancer will result in a greater rate of inhibition and thereby maximize the degree and durability of viral suppression. Given the limited therapeutic options available to most HIV-infected children, this is an option that should be explored. The study will seek to enroll 48 subjects = 2 years to 18 years of age. Subjects will be stratified by concurrent NNRTI treatment, and subjects will be treated for 48 weeks from the start of the initial LPV/r dose.