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

P1030：洛匹那韦/利托那韦治疗 HIV-1 感染婴儿 < 6 的 I/II 期研究

• 批准号: 7376191
• 负责人: Hans M Spiegel
• 金额: $ 0.27万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376191
• 关键词: P1030; PHASE; II; STUDY; LOPINAVIR

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.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中出现。列出的机构是中心的机构，不一定是研究者的机构。洛匹那韦是一种有效的蛋白酶抑制剂，即使在低 RTV 剂量下，也对利托那韦 (RTV) 的药代动力学增强敏感，从而在整个剂量间隔内提供治疗性 LPV 浓度。洛匹那韦/利托那韦在成人和 6 个月以上儿童的临床试验中显示出显着的抗病毒活性和耐受性。本研究的主要目的是 1) 评估 6 个月以下 HIV 感染婴儿的洛匹那韦/利托那韦 (LPV/RTV) 剂量要求，其提供的全身暴露量与已证明对年龄较大儿童安全有效的暴露量相似和成人，2) 确定在 < 6 个月大的 HIV 感染婴儿中启动 LPV/RTV 作为包括核苷类似物的联合治疗方案的一部分的短期和长期安全性和耐受性。