CLINICAL TRIAL: IMPAACT P1066 (VERSION 10) A PHASE I/II, MULTICENTER, OPEN-LABE

临床试验：IMPAACT P1066（版本 10）A I/II 期、多中心、开放实验室

• 批准号: 8166702
• 负责人: William Thomas Shearer
• 金额: $ 0.17万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8166702
• 关键词: 19 year old; 2 year old; Acute; Adolescence; Adolescent; Age; Anti-Retroviral Agents; Child; Childhood; Chronic; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Data; Dose; Drug Interactions; Drug Kinetics; Funding; Grant; HIV; HIV-1; IMPAACT; Infant; Institution; Medical; Patients; Phase; Plasma; Population; Regimen; Research; Research Personnel; Resistance; Resources; Safety; Source; Staging; Therapeutic; Toxic effect; United States National Institutes of Health; age group; antiretroviral therapy; dosage; experience; novel; open label; transmission process

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. There is an acute medical need for novel and potent antiretroviral therapy for HIV-infected patients who are experiencing resistance, suffer from toxicities on other possible regimens, or are failing their current antiretroviral regimen. These patients are often heavily pre-treated and have very limited or no remaining therapeutic options. The purpose of this pediatric study is to gain dosage, short and long term safety data, intensive and population PK data, drug interactions, and efficacy experience with raltegravir in HIV-1 infected children with which to guide potential usage in children ages two through adolescence. IMPAACT P1066 is a Phase I/II, multi-center, open-label, noncomparative study of approximately 120 to 140 HIV-1 infected children and adolescents ages =2 years to <19 years of age to evaluate the safety, tolerability, pharmacokinetic parameters and efficacy of raltegravir. The primary objectives are: In Stage I, to evaluate the short term safety and tolerability of raltegravir added to an initial stable background therapy which will then be optimized in children and adolescents in the age groups of =2 to <6, =6 to <12 and =12 to <19 years; In Stage I, to evaluate the steady state plasma concentration profiles and pharmacokinetic parameters of raltegravir added to stable background therapy* in children and adolescents in the age groups of =2 to <6, =6 to <12 and =12 to <19 years; and In chronic dosing, to evaluate the safety and tolerability of raltegravir at the selected dose in combination with optimized background therapy (OBT) in children and adolescents in the age groups =2 to <6, =6 to <12 and =12 to <19 years, as assessed by review of the accumulated safety data over 24 weeks. Dosage data, short and long term safety data, intensive and population PK data, drug interactions, and efficacy experience of Raltegravir (MK-0518) will help guide potential usage in HIV infected children ages two through adolescence. Primary 1. In Stage I, to evaluate the short term safety and tolerability of raltegravir added to an initial stable background therapy* which will then be optimized in children and adolescents in the age groups of =2 to <6, =6 to <12 and =12 to <19 years. 2. In Stage I, to evaluate the steady state plasma concentration profiles and pharmacokinetic parameters of raltegravir added to stable background therapy* in children and adolescents in the age groups =2 to <6, =6 to <12 and =12 to <19 years. 3. In chronic dosing, to evaluate the safety and tolerability of raltegravir at the selected dose in combination with optimized background therapy (OBT) in children and adolescents in the age groups =2 to <6, =6 to <12 and =12 to <19 years, as assessed by review of the accumulated safety data over 24 weeks. * Stable background therapy defined as unchanged therapeutic regimen for at least 12 weeks, or treatment experienced (not including therapy to interrupt maternal-infant transmission) but on no treatment for =4 weeks.

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。 对于正在经历耐药性、在其他可能的治疗方案中遭受毒性或目前的抗逆转录病毒治疗方案失败的艾滋病毒感染者来说，迫切需要新型有效的抗逆转录病毒疗法。这些患者通常接受了大量的预先治疗，并且剩余的治疗选择非常有限或没有。 这项儿科研究的目的是获得拉替拉韦在 HIV-1 感染儿童中的剂量、短期和长期安全性数据、强化和群体 PK 数据、药物相互作用和疗效经验，以指导 2 岁至青春期儿童的潜在使用。 IMPAACT P1066 是一项 I/II 期、多中心、开放标签、非比较研究，受试者为约 120 至 140 名 HIV-1 感染儿童和青少年（年龄 = 2 岁至 <19 岁），以评估安全性、耐受性、药代动力学参数和拉替拉韦的疗效。 主要目标是： 在第一阶段，评估拉替拉韦添加到初始稳定背景治疗中的短期安全性和耐受性，然后在=2至<6、=6至<年龄组的儿童和青少年中进行优化12 且 =12 至 <19 岁；在第一阶段，评估 2 岁至 <6 岁、6 岁至 12 岁以下和 12 岁至 19 岁以下儿童和青少年添加到稳定背景治疗*中的拉替拉韦的稳态血浆浓度曲线和药代动力学参数;在长期给药中，评估选定剂量的拉替拉韦与优化背景治疗（OBT）相结合，在=2至<6、=6至<12和=12至<年龄组的儿童和青少年中的安全性和耐受性19 年，通过审查 24 周内积累的安全数据进行评估。 Raltegravir (MK-0518) 的剂量数据、短期和长期安全数据、集中和群体 PK 数据、药物相互作用和疗效经验将有助于指导两岁至青春期 HIV 感染儿童的潜在使用。 基本的 1. 在第一阶段，评估拉替拉韦添加到初始稳定背景治疗*中的短期安全性和耐受性，然后在=2至<6、=6至<12和年龄组的儿童和青少年中进行优化=12 至 <19 岁。 2. 在第一阶段，评估年龄组=2至<6、=6至<12和=12至<19的儿童和青少年添加到稳定背景治疗*中的拉替拉韦的稳态血浆浓度曲线和药代动力学参数年。 3. 在长期给药中，评估选定剂量的拉替拉韦与优化背景治疗（OBT）联合治疗年龄组 =2 至 <6、=6 至 <12 和 =12 至 12 岁的儿童和青少年的安全性和耐受性。 <19 岁，通过审查 24 周内积累的安全数据进行评估。 * 稳定的背景治疗定义为至少 12 周不变的治疗方案，或经历过治疗（不包括中断母婴传播的治疗）但没有治疗 = 4 周。