COMMUNITY PROGRAMS FOR CLINICAL RESEARCH ON AIDS

特里·贝恩社区艾滋病临床研究计划(CPCRA)建议以九年进行社区临床试验的经验为基础，扩大临床网络，将美国的19个单位和澳大利亚、加拿大和英国的3个国际合作伙伴包括在内。明尼苏达大学的统计和数据管理中心、马里兰州罗克维尔的社会和科学系统业务中心以及核心CPCRA实验室将提供支持。重新配置的网络具有跟踪至少5000名研究参与者的能力。CPCRA将在相关的随机试验中比较各种抗逆转录病毒治疗策略的长期病毒学、免疫学和临床疗效，从最初的治疗开始，到随后的二线和挽救方案。CPCRA还将通过随机试验研究作为抗逆转录病毒治疗辅助手段的免疫调节的临床影响；在经历了CD4+细胞反弹的患者中预防机会性感染的药物的最佳使用；以及依从性干预。CPCRA将在核心抗逆转录病毒试验中进行嵌套分研究，针对有针对性的治疗问题，如艾滋病毒疾病和治疗的代谢并发症，以及不同治疗组中出现艾滋病毒-1耐药性。病毒学和免疫学标记物的预后重要性等发病机制问题将使用核心抗逆转录病毒试验中存储的标本来解决。标准化的模块化数据收集表格在所有研究中使用，并将用于描述临床疾病、耐药性、依从性、药物毒性、生活质量、肝炎合并感染和艾滋病毒治疗使用的模式和决定因素。在经验丰富和已经运作的委员会的建议下，一个强有力的领导层将管理CPCRA，以确保及时进行研究，收集高质量的数据，并有效地使用资源。

The Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) proposes to build on nine years of experience conducting community-based clinical trials by expanding the clinical network to include 19 units in the United States and 3 international partners in Australia, Canada, and the United Kingdom. Support will be provided from the Statistical and Data Management Center at the University of Minnesota, an Operations Center at Social and Scientific Systems in Rockville, MD and Core CPCRA Laboratories. The reconfigured network has the capability of following a minimum of 5,000 study participants. The CPCRA will compare, in linked randomized trials, the long-term virologic, immunologic, and clinical effectiveness of various antiretroviral treatment strategies beginning with initial therapy through subsequent second-line and salvage regimens. The CPCRA will also study through randomized trials the clinical impact of immunomodulation as an adjunct to antiretroviral therapy; the optimal use of agents for prophylaxis of opportunistic infections in patients who have experienced CD4+ cell rebounds; and adherence interventions. The CPCRA will conduct nested substudies in the core antiretroviral trials, on targeted therapeutic questions such as the metabolic complications of HIV disease and treatment, and the emergence of HIV-1 resistance in different treatment groups. Pathogenesis questions such as the prognostic importance of virologic and immunologic markers will be addressed using stored specimens in the core antiretroviral trials. Standardized modular data collection forms are used across studies and will be used to describe patterns and determinants of clinical disease, drug resistance, adherence, drug toxicities, quality of life, co-infection with hepatitis, and use of HIV treatment. A strong leadership, advised by experienced and already functioning committees, will manage the CPCRA to ensure that studies are conducted in a timely way, high quality data is collected and resources are used efficiently.