Patient Oriented Research in Hepatitis C-infected Injection Drug Users

丙型肝炎感染注射吸毒者的以患者为导向的研究

• 批准号: 8224954
• 负责人: Mark Sebastian Sulkowski
• 金额: $ 11.86万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-04-15 至 2017-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8224954
• 关键词: AIDS clinical trial group; Acute; Address; Adult; African; Alcohol consumption; Alcoholic Liver Diseases; Alcohols; Antiviral Agents; Antiviral Therapy; Area; Automobile Driving; Award; Behavioral; Bioethics; Biological Markers; Cessation of life; Chronic Hepatitis B; Chronic Hepatitis C; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Collaborations; Combined Modality Therapy; Communicable Diseases; Communities; Conduct Clinical Trials; Data; Development; Disease; Disease Management; Disease Outcome; Doctor of Medicine; Effectiveness; Eligibility Determination; Ensure; Faculty; Fibrosis; Frequencies; Goals; HIV; Heavy Drinking; Hepatitis; Hepatitis B; Hepatitis C; Hepatitis C virus; Histologic; Histology; Immunology; Incentives; Individual; Injecting drug user; Institute of Medicine (U.S.); Intervention; Light; Liver; Liver diseases; Malignant neoplasm of liver; Measures; Medical; Medicine; Mentorship; Metabolic; Methodology; Mid-Career Clinical Scientist Award (K24); Midcareer Investigator Award in Patient-Oriented Research; Outcome; Outcomes Research; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Pharmacology; Physician Executives; Pilot Projects; Population; Prevalence; Prevention approach; Prevention strategy; Psychological reinforcement; Public Health; Reporting; Research; Research Personnel; Research Support; Safety; Serum; South Carolina; Specimen; Staging; Targeted Research; Testing; Therapeutic; Time; Training; Training Programs; Translating; Translational Research; Translations; United States National Institutes of Health; Universities; Viral hepatitis; Virus Diseases; Work; antiretroviral therapy; bone; brief alcohol intervention; burden of illness; carbohydrate-deficient transferrin; career; cohort; computerized; drinking; graduate student; implementation research; improved; innovation; liver biopsy; medical schools; mortality; new therapeutic target; novel; patient oriented research; professor; programs; public health relevance; randomized trial; screening, brief intervention, referral, and treatment; standard care; tool; treatment as usual; virology; voucher

DESCRIPTION (provided by applicant): This is a proposal for a K24 Midcareer Investigator Award in Patient-oriented research (POR) for Mark S. Sulkowski, MD of the Johns Hopkins University School of Medicine. Dr. Sulkowski is an Associate Professor of Medicine in the Division of Infectious Diseases (ID) and Medical Director of the ID Viral Hepatitis Center. He leads two complementary POR programs for hepatitis C virus (HCV): HCV/HIV Liver Outcomes Research. The aims of this research are to evaluate long-term outcomes of HCV disease in an NIH-supported longitudinal cohort of adults coinfected with HIV and HCV. Current efforts emphasize the use of tools to determine the impact of antiretroviral therapy and HCV treatment on liver disease including histology and noninvasive transient elastography as well as interventions to improve HCV outcomes such as behavioral reinforcement for HCV treatment. HCV Therapeutics. The aim of this research is to conduct clinical trials of novel direct acting antivirals (DAAs) for the treatment of HCV with the broad goals of validating new therapeutic targets, increasing eradication rates, improving safety and tolerability and translating these findings to the community. The principal aims of this K24 Award proposal are: 1) To create a comprehensive training program that brings together expertise in outcomes research and clinical trials to prepare early clinical investigator for academic careers in POR related to HCV; 2) To dedicate research effort to the advancement of the HCV research agenda in the AIDS Clinical Trials Group (ACTG). This network has led research in HIV/HCV coinfection and has expertise in virology, immunology, pharmacology, metabolic, biostatics, bioethics, and research implementation that are critical to the HCV field; 3) To expand the scope HCV disease management in coinfected adults through the development of a research program focused on harmful alcohol intake which is prevalent in this population, accelerates HCV disease and is a contraindication to HCV treatment. These aims will be addressed in the context of providing mentorship to new and existing junior faculty, infectious diseases fellows and graduate students. The K24 will allow Dr. Sulkowski to more effectively pursue his long-term career goals of improving HCV treatment and translating these treatments to populations of individuals with the highest HCV disease burden. Public Health Relevance: This is a proposal for a Midcareer Investigator Award in Patient-Oriented Research (K24) for Mark S. Sulkowski, M.D. This award will support Dr. Sulkowski's clinical research programs in Hepatitis C; the overarching aim of this research is to improve clinical outcomes in persons with HCV through the conduct clinical trials of novel direct acting antivirals (DAAs) for the treatment of HCV and the translation of improved therapies to populations with the greatest disease burden. These aims are addressed in the context of providing mentorship to new and existing junior faculty, infectious diseases fellows and graduate students.

描述（由申请人提供）：这是约翰·霍普金斯大学医学院医学博士Mark S. Sulkowski的K24中级护理研究员奖（POR）的提案。 Sulkowski博士是传染病科（ID）的医学副教授和ID病毒肝炎中心的医疗主任。他领导了丙型肝炎病毒（HCV）的两个互补POR计划：HCV/HIV肝脏结果研究。这项研究的目的是评估与HIV和HCV共同感染的NIH支持的成年人的长期结局。当前的努力强调使用工具来确定抗逆转录病毒疗法和HCV治疗对肝病的影响，包括组织学和非侵入性瞬时弹性弹性，以及改善HCV结果的干预措施，例如HCV治疗的行为增强。 HCV治疗学。这项研究的目的是对新型直接作用抗病毒药（DAAS）进行临床试验，以验证新的治疗靶标，提高根除率，提高安全性和耐受性并将这些发现转化为社区。该K24奖励提案的主要目的是：1）创建一项全面的培训计划，汇集了成果研究和临床试验的专业知识，以准备与HCV相关的POR学术生涯的早期临床研究者； 2）将研究工作献给艾滋病临床试验小组（ACTG）中HCV研究议程的发展。该网络领导了HIV/HCV共感染的研究，并在病毒学，免疫学，药理学，代谢，生物术，生物伦理学和研究实施方面具有专业知识，对HCV领域至关重要； 3）通过开发针对有害酒精摄入量的研究计划，扩大成年人共感染的范围HCV疾病管理，该计划在该人群中很普遍，可以加速HCV疾病，并且是HCV治疗的禁忌症。这些目标将在为新的和现有的初级教师，传染病研究员和研究生提供指导的背景下解决。 K24将允许Sulkowski博士更有效地追求他的长期职业目标，即改善HCV治疗并将这些治疗方法转化为HCV疾病负担最高的人群的人群。 公共卫生相关性：这是对以患者为导向研究的中级研究员奖（K24）的提案，该奖项是Mark S. Sulkowski，M.D。该奖项将支持Sulkowski博士在乙型肝炎中的临床研究计划；这项研究的总体目的是通过对HCV治疗的新型直接作用抗病毒药（DAAS）进行临床试验来改善HCV患者的临床结果，并将改善疗法转化为具有最大疾病负担的人群的改善疗法。这些目标是在为新的和现有的初级教师，传染病研究员和研究生提供指导的背景下解决的。