CPCRA Clinical Trials Unit

描述(由申请人提供)： CPCRA临床试验单位(社区艾滋病临床研究计划)的目标是：在预防和治疗艾滋病毒疾病及其并发症方面进行临床相关研究；让人口、地理和社会经济状况不同的艾滋病毒感染者或感染风险人群参与临床试验；并与本身感染艾滋病毒或受艾滋病毒影响的社区成员密切合作开展这项研究议程。 CPCRA CTU将在登记和科学专门知识方面为Insight和艾滋病毒预防试验(HPTN)网络做出重大贡献。通过洞察，CPCRA CTU将为多个随机临床试验做出贡献，以帮助确定艾滋病毒感染者的最佳临床治疗方案。这些试验包括对以下人群的研究：高度抗逆转录病毒(ARV)治疗经验，且无法实现和维持病毒学抑制；ARV幼稚，患有晚期艾滋病毒疾病，并出现机会性感染；同时感染艾滋病毒和肝炎病毒；或处于心血管疾病的中到高度风险。通过HPTN，CPCRA CTU将为检验行为和治疗干预与行为和生物学结果的试验做出贡献，寻求减少艾滋病毒传播和艾滋病毒传播风险行为。目标人群包括艾滋病毒感染者，以及艾滋病毒携带者和血清转换高危人群，如注射毒品和可卡因使用者，以及通过性接触而有血清转换风险的其他人。 CPCRA临床试验中心的执行办公室位于华盛顿特区的退伍军人事务医疗中心，是申请机构乔治华盛顿大学的校外附属机构。首席调查员和执行办公室工作人员为其137个CRSS提供监督、中央协调、培训和教育、技术援助和监管支持，这些CRSS按区域组织在美国、巴西、加拿大、秘鲁和南非的23个现场协调中心(SCC)。这些地点有一个累积的、人口结构多样化的艾滋病毒/艾滋病患者基础，超过152000人。 艾滋病毒是世界各地的一个主要公共卫生问题。重要的是找到更好的方法来使用我们治疗艾滋病毒的药物，这样感染者就可以活得更长、更健康。同样重要的是，通过对艾滋病毒感染者和没有艾滋病毒但有感染艾滋病毒风险的人进行研究，找到更好的方法来阻止艾滋病毒的传播。 管理组件：

DESCRIPTION (provided by applicant): The objectives of the CPCRA Clinical Trials Unit (Community Programs for Clinical Research on AIDS) are: to conduct clinically relevant research in the prevention and treatment of HIV disease and its complications; to involve in clinical trials a demographically, geographically, and socio-economically diverse population of individuals infected with HIV or at risk of infection; and to carry out this research agenda in close collaboration with community members who are themselves infected with or affected by HIV. The CPCRA CTU will make significant contributions to the INSIGHT and HIV Prevention Trials (HPTN) networks, both in enrollment and in scientific expertise. Through INSIGHT, the CPCRA CTU will contribute to multiple, randomized clinical trials in order to help determine the optimal clinical management for persons who are HIV+. These trials include studies of those who are: highly-antiretroviral (ARV) experienced and for whom virologic suppression cannot be achieved and maintained; ARV-naive, with advanced HIV disease and presenting for care with an opportunistic infection; co-infected with HIV and hepatitis virus; or at moderate-to-high risk of cardiovascular disease. Through the HPTN, the CPCRA CTU will contribute to trials examining both behavioral and therapeutic interventions with behavioral and biologic outcomes, seeking to reduce HIV transmission and HIV transmission-risk behavior. Targeted populations include those who are HIV+, as well as those who are HIV- and at-risk for seroconversion, such as injecting-drug and cocaine users and others at risk for seroconversion through sexual contact. The Executive Office of the CPCRA Clinical Trials Unit, located at the Veterans Affairs Medical Center in Washington DC, is an off-campus affiliate of the applicant institution, The George Washington University. The Principal Investigator and Executive Office staff provide oversight, central coordination, training and education, technical assistance, and regulatory support for its 137 CRSs, organized by region into 23 Site Coordinating Centers (SCCs) in the United States, Brazil, Canada, Peru, and South Africa. These sites have in care a cumulative, demographically diverse patient base of over 152,000 persons with HIV/AIDS. HIV is a major public health problem around the world. It is important to find better ways to use the medicines that we have to treat HIV, so that people who are infected can live longer and healthier lives. It is also important to find better ways to stop the spread of HIV by doing studies with people who have HIV infection and people who don't have HIV but who are at risk for getting HIV infection. ADMINISTRATIVE COMPONENT: