CPCRA Clinical Trials Unit

描述（由申请人提供）： CPCRA 临床试验单位（艾滋病临床研究社区计划）的目标是： 开展预防和治疗艾滋病毒疾病及其并发症的临床相关研究；参与临床试验的人口、地理和社会经济多样化的艾滋病毒感染者或有感染风险的个体；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。 CPRA CTU 将为 INSIGHT 和 HIV 预防试验 (HPTN) 网络在招募和科学专业知识方面做出重大贡献。通过 INSIGHT，CPCRA CTU 将参与多项随机临床试验，以帮助确定 HIV 感染者的最佳临床管理方案。这些试验包括对以下人群的研究： 接受过高度抗逆转录病毒 (ARV) 治疗且无法实现和维持病毒学抑制；未经抗逆转录病毒治疗，患有晚期艾滋病毒并因机会性感染而就诊；同时感染艾滋病毒和肝炎病毒；或有中度至高度心血管疾病风险。通过 HPTN，CPCRA CTU 将有助于开展试验，检查行为和治疗干预措施的行为和生物学结果，寻求减少 HIV 传播和 HIV 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感染者和有血清转化风险的人群，例如注射吸毒者和可卡因使用者以及其他有通过性接触发生血清转化风险的人。 CPCRA 临床试验部门的执行办公室位于华盛顿特区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。首席研究员和执行办公室工作人员为其 137 个 CRS 提供监督、中央协调、培训和教育、技术援助以及监管支持，这些 CRS 按地区组织为位于美国、巴西、加拿大、秘鲁和南非的 23 个站点协调中心 (SCC)。这些站点累计护理了超过 152,000 名艾滋病毒/艾滋病患者，人口结构多样。 艾滋病毒是世界各地的一个主要公共卫生问题。找到更好的方法来使用我们治疗艾滋病毒的药物非常重要，这样感染者就可以活得更长久、更健康。通过对艾滋病毒感染者和未感染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传播也很重要。 行政部分：

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: