PACTG 1038:PHASE I/II HIGH DOSE LOPINAVIR/RITONAVIR WITH OR WITHOUT SAQUINAVIR I

PACTG 1038：I/II 期高剂量洛匹那韦/利托那韦，含或不含沙奎那韦 I

• 批准号: 7380759
• 负责人: Kenneth McIntosh
• 金额: $ 13.6万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7380759
• 关键词: PACTG; 1038; PHASE; II; DOSE

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. Primary: 1. To determine the safety and tolerability of high dose LPV/r in Group 1 (400/100 mg/m2 PO Q12H) and Group 2 (480/120 mg/m2 PO Q12H) with concurrent NNRTI treatment. 2. To evaluate the safety and tolerability of saquinavir (750mg/m2 or 1200 mg/m2 PO Q12H) in combination with LPV/r in children and adolescents (Step 2 and Step 3). 3. To estimate pharmacokinetic parameters for LPV/r and saquinavir in protease inhibitor experienced HIV-infected children and adolescents receiving combination antiretroviral regimens.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。小学：1.确定第1组（400/100 mg/m2 PO Q12 H）和第2组（480/120 mg/m2 PO Q12 H）高剂量LPV/r与NNRTI联合治疗的安全性和耐受性。 2.评价沙奎那韦（750 mg/m2或1200 mg/m2 PO Q12 H）联合LPV/r治疗儿童和青少年的安全性和耐受性（第2步和第3步）。 3.估计LPV/r和沙奎那韦在接受抗逆转录病毒联合治疗的HIV感染儿童和青少年中的药代动力学参数。