CPCRA Clinical Trials Unit

CPRA 临床试验单位

• 批准号: 8015262
• 负责人: Fred M Gordin
• 金额: $ 964.14万
• 依托单位: GEORGE WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-06-15 至 2014-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8015262
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Affect; Anti-Retroviral Agents; Behavior Therapy; Behavioral; Brazil; Canada; Cardiovascular Diseases; Caring; Clinical Management; Clinical Research; Clinical Trials; Clinical Trials Unit; Cocaine Users; Collaborations; Communities; Disease; District of Columbia; Enrollment; HIV; HIV Infections; HIV prevention trial; HIV prevention trials network; Hepatitis Viruses; Individual; Infection; Injecting drug user; Institution; Life; Medical center; Medicine; Opportunistic Infections; Outcome; Patients; Persons; Peru; Population Heterogeneity; Prevention; Principal Investigator; Public Health; Randomized Clinical Trials; Research; Risk; Risk Behaviors; Site; South Africa; Target Populations; Therapeutic Intervention; Training and Education; United States; Universities; Veterans; Washington; base; clinically relevant; experience; high risk; member; programs; transmission process

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:

描述（由申请人提供）： CPCRA临床试验部门的目标（有关艾滋病临床研究的社区计划）是：在预防和治疗HIV疾病及其并发症方面进行临床相关研究；参与临床试验，在人口统计学，地理和社会经济上有多样化的人群感染了艾滋病毒或感染风险；并与自己感染或受艾滋病毒影响的社区成员进行密切合作，进行这项研究议程。 CPCRA CTU将在入学和科学专业知识方面为洞察力和艾滋病毒预防试验（HPTN）网络做出重大贡献。通过Insight，CPCRA CTU将有助于多次随机临床试验，以帮助确定HIV+患者的最佳临床管理。这些试验包括对那些是：经验丰富的高度抗逆转录病毒（ARV）的研究，并且无法实现和维持病毒学抑制； Arv-Neive，患有晚期艾滋病毒疾病，并以机会性感染为护理；与HIV和肝炎病毒共同感染；或患心血管疾病的中等风险。通过HPTN，CPCRA CTU将有助于通过行为和生物学结果来检查行为和治疗干预措施的试验，以寻求减少HIV传播和HIV传播风险行为。有针对性的人群包括那些艾滋病毒+的人，以及那些患有血清转化的艾滋病毒和高危人群，例如注射药物和可卡因用户以及其他通过性接触有血清转化风险的人。 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，是乔治华盛顿大学申请人机构的校外分支机构。首席调查员和执行办公室的工作人员为其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，由地区组织为23个现场协调中心（SCC），在美国，巴西，加拿大，秘鲁，秘鲁和南非。这些站点有一个累积的，人口统计多样化的患者基础，其中超过152,000人患有艾滋病毒/艾滋病。 艾滋病毒是世界上一个主要的公共卫生问题。重要的是要找到更好的方法来使用我们必须治疗艾滋病毒的药物，以便被感染的人生活更长，更健康。通过与患有艾滋病毒感染的人和没有艾滋病毒但有艾滋病毒感染风险的人进行研究，找到更好的方法来阻止艾滋病毒的传播。 管理组件：