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）：这是一个K24职业中期研究者奖的建议，以患者为导向的研究（POR）为马克S。约翰霍普金斯大学医学院的医学博士Sulkowski说。Sulkowski博士是传染病科（ID）的医学副教授，也是ID病毒性肝炎中心的医学主任。他领导了两个互补的丙型肝炎病毒（HCV）POR项目：HCV/HIV肝脏结局研究。本研究的目的是在NIH支持的HIV和HCV合并感染的成人纵向队列中评估HCV疾病的长期结局。目前的努力强调使用工具来确定抗逆转录病毒治疗和HCV治疗对肝脏疾病的影响，包括组织学和无创瞬时弹性成像以及改善HCV结果的干预措施，例如HCV治疗的行为强化。HCV治疗。本研究的目的是进行新型直接作用抗病毒药物（DAA）治疗HCV的临床试验，其广泛目标是验证新的治疗靶点，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奖提案的主要目的是：1）创建一个综合培训计划，汇集成果研究和临床试验方面的专业知识，为HCV相关POR的学术生涯做好早期临床研究人员的准备; 2）致力于研究工作，以推进艾滋病临床试验组（ACTG）的HCV研究议程。该网络领导了艾滋病毒/丙型肝炎病毒合并感染的研究，并拥有对丙型肝炎病毒领域至关重要的病毒学、免疫学、药理学、代谢学、生物静力学、生物伦理学和研究实施方面的专门知识; 3）通过制定一项研究计划，扩大合并感染成人的HCV疾病管理范围，该计划侧重于该人群中普遍存在的有害酒精摄入，加速HCV疾病，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将使Sulkowski博士能够更有效地追求他的长期职业目标，即改善HCV治疗并将这些治疗转化为HCV疾病负担最高的人群。 公共卫生相关性：这是一个建议，为中期职业生涯研究者奖在以病人为导向的研究（K24）马克S。Sulkowski，医学博士该奖项将支持Sulkowski博士在丙型肝炎方面的临床研究计划;该研究的总体目标是通过开展新型直接作用抗病毒药物（DAA）治疗HCV的临床试验以及将改进的治疗方法转化为疾病负担最大的人群来改善HCV患者的临床结局。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。