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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 PACTG P1038是一项I/II期的大剂量洛比那韦/利托那韦(LPV/r)开放标签研究，旨在评估在使用或不使用沙奎那韦(SQV)的情况下，使用或不使用沙奎那韦(SQV)的LPV/r在HIV感染儿童和青少年中的安全性、耐受性和药代动力学，这些儿童和青少年有至少六个月的PI经历，并且目前的抗逆转录病毒治疗失败(血浆HIV RNA大于5000拷贝/毫升)。 这项研究假设，剂量增强不仅有助于克服耐药性，而且以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，这是一个应该探索的选择。这项研究将寻求招募48名受试者=2岁至18岁。受试者将根据同时进行的NNRTI治疗进行分层，受试者将从最初的LPV/r剂量开始接受为期48周的治疗。

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. PACTG 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 greater than 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.