The Ohio State University AIDS Clinical Trials Unit

描述(由申请人提供)：俄亥俄州立大学(OSU)艾滋病临床试验中心(ACTU)计划进行临床研究，以增加对艾滋病毒的发病机制、预防、病程和治疗的了解 通过与艾滋病临床诊所事先达成协议的从属关系引起的感染及其相关并发症 由加州大学圣地亚哥分校的康斯坦斯·本森博士领导的试验小组(ACTG)和 还建议加入由劳伦斯·科里博士领导的艾滋病毒疫苗试验网络(HVTN) 华盛顿州西雅图的华盛顿大学。将设计和实施临床试验：1) 优化HIV及其相关并发症的临床管理；2)评估新药物 治疗艾滋病毒和/或主要共病原体的作用机制或改善的毒性曲线 (3)评价其安全性、免疫原性和疗效。 开发多种候选艾滋病毒疫苗和佐剂；4)开发减少艾滋病毒传播的方法 通过将艾滋病毒治疗与预防工作相结合，评估实际的行为干预措施，并 其他传输中断方法；以及5)通过以下方式将垂直传输的风险降至最低 最大限度地照顾感染艾滋病毒的妇女在其育龄期间。 来自不同年龄、社区和社会经济条件的艾滋病毒感染者 将被招募、筛选和登记参加解决这些高优先级研究的特定方案 俄亥俄州立大学ACTU的区域。协调与研究相关的活动，并及时执行新的 研究将利用成熟的研究人员的专业知识，与 科学家同事和艾滋病毒感染者社区以及临床研究基础设施 在过去18年和最近的大规模活动中，因其在ACTG中的生产力而受到认可 疫苗和预防试验。有经验的研究人员(调查人员、护士、药房、数据 管理、实验室和外展人员)将招聘、筛选、登记和管理所有必要的 以及参与临床试验的必备要素。 开发和测试HIV感染的策略和新治疗方法的临床研究 并发症对于控制HIV疾病的进展和减少副作用至关重要 效果。设计良好的临床试验以测试疫苗和其他预防策略是至关重要的 防止艾滋病毒感染的传播。

DESCRIPTION (provided by applicant): The Ohio State University (OSU) AIDS Clinical Trials Unit (ACTU) plans to conduct clinical research that will increase knowledge about the pathogenesis, prevention, course, and treatment of HIV infection and its associated complications through affiliation by prior agreement with the AIDS Clinical Trials Group (ACTG) led by Dr. Constance Benson of the University of California, San Diego, CA and also proposes to affiliate with the HIV Vaccine Trials Network (HVTN) led by Dr. Lawrence Corey of the University of Washington, Seattle WA. Clinical trials will be designed and implemented: 1) to optimize the clinical management of HIV and its related complications; 2) to evaluate agents with novel mechanisms of action or improved toxicity profiles for the treatment of HIV and/or for major co-pathogens (such as tuberculosis and hepatitis); 3) to evaluate the safety, immunogenicity, and efficacy of multiple candidate HIV vaccines and adjuvants; 4) to develop means of reducing HIV transmission by integrating HIV treatment with prevention efforts that evaluate practical behavioral interventions and other methods of transmission interruption; and 5) to minimize the risk of vertical transmission by maximizing care of HIV-infected women during their child-bearing years. HIV-infected individuals from a wide spectrum of ages, communities and socio-economic conditions will be recruited, screened and enrolled in specific protocols that address these high priority research areas at the OSU ACTU. Coordination of research related activities and timely execution of new studies will take advantage of established investigator expertise, ongoing productive partnerships with scientist colleagues and the HIV-infected community and a clinical research infrastructure that is recognized for its productivity in the ACTG over the past 18 years and more recently in large scale vaccine and prevention trials. Experienced research staff (investigators, nurses, pharmacy, data management, laboratory and outreach personnel) will recruit, screen, enroll and manage all essential and required elements of clinical trials participation. Clinical research that develops and tests strategies and new treatments for HIV infection and its complications is critically important for controlling HIV disease progression and minimizing side effects. Well-designed clinical trials to test vaccines and other preventive strategies are essential to preventing the spread of HIV infection.