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

PACTG P1038：高剂量洛匹那韦/利托那韦联合或不联合沙奎那韦治疗 HIV PTS

• 批准号: 7604296
• 负责人: Ram Yogev
• 金额: $ 0.81万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604296
• 关键词: PACTG; P1038; DOSE; LOPINAVIR; RITONAVIR

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 PACTG P1038 是一项高剂量洛匹那韦/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之前有至少六个月的 PI 经验并且目前的抗逆转录病毒治疗失败（血浆 HIV RNA 大于 5000 拷贝/mL）。 这项研究假设，剂量强化不仅有助于克服耐药性，而且会以类似于癌症的方式导致更高的抑制率，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，这是一个值得探索的选择。 该研究将招募 48 名年龄在 2 岁至 18 岁之间的受试者。 受试者将通过同时 NNRTI 治疗进行分层，受试者将从初始 LPV/r 剂量开始治疗 48 周。