Pharmacologic Determinants for Optimized Therapy in HIV-Infected Children

HIV 感染儿童优化治疗的药理学决定因素

基本信息

批准号：
7338088
负责人：
ADRIANA H TREMOULET
金额：
$ 12.18万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN DIEGO
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-09-01 至 2012-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7338088
关键词：
Accounting Adherence Adolescent Advisory Committees Affect Age CD4 Lymphocyte Count California Child Child health care Childhood Clinic Clinical Clinical Pharmacology Clinical Research Clinical Trials Clinical Trials Design Communicable Diseases Computer software Data Development Development Plans Diagnosis Didanosine Disease model Dose Drug Exposure Drug Kinetics Education Ensure Ethnic Origin Evaluation Fellowship Gender Goals Guidelines HIV Highly Active Antiretroviral Therapy International Maternal Pediatric Adolescent AIDS Clinical Trials Group Journals Laboratories Lamivudine Lamivudine/Zidovudine Lead Learning Master&apos s Degree Mentored Patient-Oriented Research Career Development Award Mentors Mentorship Methods Mexico Minimum Inhibitory Concentration measurement Modeling Mothers Multivariate Analysis Outcome Pediatrics Pharmaceutical Preparations Pharmacodynamics Pharmacology Physicians Plasma Population Process Publications RNA Race Range Recommendation Recruitment Activity Renal function Research Research Training Resistance development Resources Scientist Simulate Structure Techniques Time TimeLine Training Treatment Protocols Universities Use of New Techniques Validation Variant Viral Weight antiretroviral therapy base career clinical effect design model design models and simulation mutant novel pediatric department pediatric pharmacology pharmacokinetic model prevent programs research and development response simulation sound

项目摘要

DESCRIPTION (provided by applicant): With a long-term career goal of designing and executing pediatric clinical drug trials focused on understanding the pharmacology of infectious disease therapies, I seek support in my career development through this Mentored Patient-Oriented Research Career Development Award (K23). With the completion of my Pediatric Infectious Diseases fellowship in June 2007, this career development plan will provide me with the necessary components for an independent physician-scientist career path at the interface between pediatric infectious diseases and pharmacology via the following: (1) formal education in pediatric pharmacology and clinical trials design, including advanced coursework in pharmacology, pharmacology seminars and journal clubs, training in the responsible conduct of research, and a Masters degree in Clinical Research at the University of California, San Diego (UCSD), (2) research training in population pharmacologic modeling, simulation, and clinical pharmacology analysis techniques at UCSD's Pediatric Pharmacology Research Unit (PPRU) and UCSD's International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) group laboratory, and (3) a structured plan for publications, presentations, and mentoring oversight. This proposal is feasible because of the sound career development and research plans as well as the strong support from my mentors, advisory committee, and the Department of Pediatrics at UCSD. Despite the worldwide use of antiretrovirals in HIV-infected children, little pharmacologic data exists to determine whether the current dosing regimens are optimal. Under the guidance of Dr. Capparelli, Director of UCSD's PPRU and Dr. Spector, Director of UCSD's Mother Child Adolescent HIV Program, I will focus my research on the pharmacologic determinants that affect the pharmacokinetics and pharmacodynamics of lamivudine, zidovudine, and diagnosing in HIV-infected children. By simulating the effects of the population models developed in this proposal, we will determine whether the current dosing regimens provide optimal plasma concentrations. These data are important for the health of children worldwide as our data will provide novel, critical pharmacologic information about antiretrovirals in children and ensure that current guidelines provide optimal dosing for HIV-infected children across a wide age range.

描述（由申请人提供）：以长期的职业目标设计和执行儿科临床药物试验，重点是了解传染病疗法的药理学，我通过这项受过指导的以患者为导向的研究职业发展奖（K23）在我的职业发展中寻求支持。 With the completion of my Pediatric Infectious Diseases fellowship in June 2007, this career development plan will provide me with the necessary components for an independent physician-scientist career path at the interface between pediatric infectious diseases and pharmacology via the following: (1) formal education in pediatric pharmacology and clinical trials design, including advanced coursework in pharmacology, pharmacology seminars and journal clubs, training in the responsible conduct of研究，以及加州大学圣地亚哥分校（UCSD）的临床研究硕士学位，（2）在UCSD的儿科药理学研究单元（PPRU）和UCSD的国际孕产妇辅助效力（IMPA）组合（IMPA）组成（IMPA），演讲和指导监督。该提案是可行的，因为合理的职业发展和研究计划以及我的导师，咨询委员会和UCSD儿科部的大力支持。尽管全球抗逆转录病毒在HIV感染的儿童中使用了抗逆转录病毒，但很少有药理学数据可以确定当前的剂量方案是否最佳。在UCSD的PPRU主任Capparelli博士和UCSD母童青少年艾滋病毒计划主任Spector博士的指导下，我将重点关注我的研究上，这些决定因素会影响兰米夫定，Zidovudine，Zidovudine和HIV受HIV侵害儿童的药代动力学和药态动力学的药理决定因素。通过模拟本提案中开发的种群模型的影响，我们将确定当前的给药方案是否提供最佳的血浆浓度。这些数据对于全球儿童的健康很重要，因为我们的数据将提供有关儿童抗逆转录病毒病的新颖，关键的药理信息，并确保当前的准则为跨年龄范围内的HIV感染儿童提供最佳剂量。