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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 对于患有抗药性，对其他可能治疗方案的毒性或目前的抗逆转录病毒方案失败的艾滋病毒感染患者，急性医疗需要新颖和有效的抗逆转录病毒疗法。这些患者通常经过大量预处理，并且没有剩余的治疗选择。 这项小儿研究的目的是获得剂量，短期和长期安全数据，密集和人口PK数据，药物相互作用以及与Raltegravir在HIV-1感染的儿童中的疗效经验，并在青春期中指导两岁的儿童使用，以指导潜在的使用。 Imbaact P1066是I/II期，多中心，开放标签，非比较研究，对大约120至140个HIV-1感染的儿童和青少年= 2岁至<19岁，以评估Raltegravir的安全性，耐受性，可耐受性，药物代动力学参数和效率。 主要目标是：在第I阶段，要评估Raltegravir的短期安全性和耐受性，并将其添加到初始稳定的背景疗法中，然后在年龄段的儿童和青少年中对2至2至<6的儿童和青少年进行优化，= 6至6至<12 and = 12至<19岁至<19岁；在第一阶段，在= 2至<6的儿童和青少年中，在稳定的背景治疗中添加了Raltegravir的稳态血浆浓度谱和药代动力学参数*，= 6至<6至<12和= 12至<19年；在慢性剂量中，以评估Raltegravir在选定剂量上的安全性和耐受性，并在年龄组中的儿童和青少年在= 2至<6，= 6至<12和= 12至<19年的儿童和青少年中结合使用优化的背景治疗（OBT），并通过在24周内审查累积的安全数据评估。 Raltegravir（MK-0518）的剂量数据，短期和长期安全数据，密集和人口PK数据，药物相互作用以及疗效经验将有助于指导在青春期至青春期的HIV感染儿童中的潜在使用。 基本的 1。在第I阶段，为了评估Raltegravir的短期安全性和耐受性，添加到了初始稳定的背景治疗*中，然后将在年龄= 2至<6的儿童和青少年中进行优化，= 2至<6，= 6至<12和= 12至<19年。 2。在第I阶段，为了评估Raltegravir的稳态血浆浓度谱和药代动力学参数添加到稳定的背景治疗*中的儿童和青少年在年龄组中= 2至<6，= 6至<6，= 6至<12和= 12至<19年。 3。在慢性剂量中，以评估Raltegravir在选定剂量上的安全性和耐受性，并在年龄段的儿童和青少年中结合使用优化的背景治疗（OBT）= 2至<6，= 6至<6，= 6至<12至<12至<19年，通过在24周内审查累积的安全数据评估。 *稳定的背景治疗至少12周定义为未改变的治疗方案，或经历过的治疗（不包括打断孕产妇传播的治疗），而是在= 4周内没有治疗。