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，通过与加州大学圣地亚哥分校的康斯坦斯·本森博士领导的艾滋病临床试验小组(ACTG)事先达成协议，增加对艾滋病毒感染及其相关并发症的发病机制、预防、病程和治疗的知识，并建议加入由西雅图华盛顿大学的劳伦斯·科里博士领导的艾滋病毒疫苗试验网络(HVTN)。将设计和实施临床试验：1)优化艾滋病毒及其相关并发症的临床管理；2)评价用于治疗艾滋病毒和/或主要共病原体(如结核病和肝炎)的具有新作用机制或毒性曲线改善的药物；3)评估多种候选艾滋病毒疫苗和佐剂的安全性、免疫原性和有效性；4)通过将艾滋病毒治疗与预防工作相结合，开发减少艾滋病毒传播的手段，评估切实可行的行为干预措施及其他传播阻断方法；以及5)通过最大限度地照顾感染艾滋病毒的妇女育龄期间，最大限度地减少垂直传播的风险。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、筛选并参加具体的方案，以解决OSU ACTU的这些高度优先的研究领域。与研究有关的活动的协调和新研究的及时执行将利用现有的研究人员专业知识、与科学家同事和艾滋病毒感染者社区持续的富有成效的伙伴关系以及临床研究基础设施，该基础设施在过去18年的ACTG以及最近的大规模疫苗和预防试验中因其生产力而得到公认。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)将招募、筛选、登记和搜寻参与临床试验的所有基本和必要的要素。开发和测试针对艾滋病毒感染及其并发症的策略和新治疗方法的临床研究对于控制艾滋病毒疾病的进展和最大限度地减少副作用至关重要。设计良好的临床试验来测试疫苗和其他预防策略对于防止艾滋病毒感染的传播至关重要。 管理组件：

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 copathogens (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 rummage 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. ADMINISTRATIVE COMPONENT: