PACTG 1038

PACTG 1038

• 批准号: 7603225
• 负责人: Robert Floyd Pass
• 金额: $ 0.09万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603225
• 关键词: Adolescent; Age-Years; Anti-Retroviral Agents; Child; Computer Retrieval of Information on Scientific Projects Database; Dose; Enrollment; Funding; Grant; HIV; HIV Seropositivity; Institution; Label; Lopinavir/Ritonavir; Monitor; Phase; Plasma; Protease Inhibitor; RNA; Research; Research Personnel; Resources; Safety; Saquinavir; Source; Staging; Therapeutic; Treatment Protocols; United States National Institutes of Health; Week; antiretroviral therapy; experience; non-nucleoside reverse transcriptase inhibitors

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 PI038 is a Phase I/II, open label study of high dose Lopinavir/Ritonavir +/- Saquinavir 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). 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 for the start of the initial LPV/v dose. The primary objectives are to determine the safety, tolerability of high dose Lopinavir/Ritonavir (and for some subjects, Saquinavir) with concurrent NNRTI treatment in children and adolescents as well as to monitor the harmacokinetic parameters for LPV/r and Saquinavir in protease inhibitor experienced HIV-infected subjects receiving combination antiretroviral regimens. PACTG 1038 seeks to offer therapeutic options for HIV positive children and adolescents who may have previously failed antiretroviral regimens and optimize therapy with protease inhibitors in those with late-stage HIV.

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。子项目和 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 中心，不一定是研究者的机构。 PACTG PI038 是一项针对 HIV 感染儿童和青少年的高剂量洛匹那韦/利托那韦 +/- 沙奎那韦的 I/II 期开放标签研究，这些儿童和青少年之前至少有 6 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 >5000 份/毫升）。该研究将招募 48 名年龄 >2 岁至 <18 岁的受试者。受试者将通过同时 NNRTI 治疗进行分层，受试者将在初始 LPV/v 剂量开始时接受 48 周的治疗。 主要目标是确定高剂量洛匹那韦/利托那韦（对于某些受试者，沙奎那韦）与同时 NNRTI 治疗的儿童和青少年的安全性和耐受性，以及监测蛋白酶抑制剂中 LPV/r 和沙奎那韦的危害动力学参数。接受联合抗逆转录病毒治疗的 HIV 感染者。 PACTG 1038 旨在为先前抗逆转录病毒疗法可能失败的 HIV 阳性儿童和青少年提供治疗选择，并优化晚期 HIV 患者的蛋白酶抑制剂治疗。