The Ohio State University AIDS Clinical Trials Unit

描述（由申请人提供）：俄亥俄州立大学（OSU）艾滋病临床试验小组（ACTU）计划开展临床研究，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、病程和治疗的认识。并提议加入由华盛顿州西雅图华盛顿大学的Lawrence Corey博士领导的艾滋病毒疫苗试验网络（HVTN）。临床试验的设计和实施：1)优化HIV及其相关并发症的临床管理；2)评估具有新的作用机制或改善毒性的药物，用于治疗艾滋病毒和/或主要病原体（如结核病和肝炎）；3)评价多种候选HIV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结合起来，评估实际的行为干预措施和其他阻断传播的方法，开发减少艾滋病毒传播的手段；5)通过最大限度地照顾育龄期感染艾滋病毒的妇女，尽量减少垂直传播的风险。将在俄勒冈州立大学ACTU招募、筛选和登记来自不同年龄、社区和社会经济条件的艾滋病毒感染者，以处理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已确立的研究人员专门知识、与科学家同事和艾滋病毒感染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年中在ACTG中以及最近在大规模疫苗和预防试验中因其生产力而得到认可。经验丰富的研究人员（调查员、护士、药房、数据管理、实验室和外联人员）将招募、筛选、登记和翻查参与临床试验的所有必要因素。制定和测试艾滋病毒感染及其并发症的战略和新疗法的临床研究对于控制艾滋病毒疾病进展和尽量减少副作用至关重要。为检验疫苗和其他预防战略而精心设计的临床试验对于预防艾滋病毒感染的传播至关重要。

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: