CPCRA Clinical Trials Unit

CPRA 临床试验单位

• 批准号: 8011830
• 负责人: Fred M Gordin
• 金额: $ 22.67万
• 依托单位: GEORGE WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-02-01 至 2011-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8011830
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Affect; Anti-Retroviral Agents; 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; Institution; International Network for Strategic Initiatives in Global HIV Trials; Life; Medical center; Medicine; Opportunistic Infections; Outcome; Patients; Persons; Peru; Pharmaceutical Preparations; 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; clinical research site; clinically relevant; experience; high risk; member; programs; transmission process

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-nai've, 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 clinical research sites, organized by region into 23 Site Coordinating Centers 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.

CPCRA临床试验单位（社区临床研究计划）的目标 艾滋病）是：在预防和治疗艾滋病毒疾病方面进行临床相关研究， 并发症;参与临床试验的人口，地理和社会经济多样性 艾滋病毒感染者或有感染风险的人的人口;并在下列国家开展这项研究议程： 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。 CPCRA CTU将为INSIGHT和艾滋病毒预防试验（HPTN）做出重大贡献 网络，无论是在招生和科学专业知识。通过INSIGHT，CPCRA CTU将为 多个随机临床试验，以帮助确定最佳的临床管理的人 谁是HIV+。这些试验包括对以下人群的研究：高度抗逆转录病毒（ARV）经验丰富， 无法实现和维持病毒学抑制的患者;未接受过抗逆转录病毒治疗的晚期艾滋病患者 并因机会性感染而就诊;同时感染HIV和肝炎病毒;或 中度至高度的心血管疾病风险。通过HPTN，CPCRA CTU将为审判做出贡献 检查行为和治疗干预与行为和生物结果，寻求 减少艾滋病毒传播和艾滋病毒传播危险行为。目标人群包括那些 艾滋病毒阳性者，以及艾滋病毒阴性者和有血清转化风险的人，如注射毒品和可卡因使用者 以及其他有通过性接触感染血清转化风险的人。 CPCRA临床试验部门的执行办公室，位于退伍军人事务医疗中心 位于华盛顿特区，是申请机构乔治华盛顿大学的校外附属机构。 主要调查员和执行办公室工作人员提供监督、中央协调、培训和 为137个临床研究中心提供教育、技术援助和监管支持， 在美国、巴西、加拿大、秘鲁和南非的23个研究中心协调中心。这些 临床试验机构的累计患者人数超过152，000人， 艾滋病毒/艾滋病的