THE IMPACTA PERU CLINICAL TRIALS UNIT

描述(由申请人提供)：拟议的多功能IMPACTA秘鲁CTU是一个研究人员联盟，研究人员来自美国公民IMPACTA Salud y Education acion(IMPACTA)、ASocial acion Civil Selva Amazonica(ACSA)、国家Dos de Mayo医院(HNDM)和美国海军医学研究中心支队(NMRCD)。反恐组总部设在IMPACTA，这是一个致力于艾滋病毒研究的非政府组织，由豪尔赫·桑切斯博士领导，由一批经验丰富的研究人员和有前途的初级调查人员提供支持。自2000年以来，它一直隶属于艾滋病毒疫苗试验网络(HVTN)和艾滋病毒预防试验网络(HPTN)，并自2002年以来加入了艾滋病临床试验小组(ACTG)。在过去的5年里，NIH在IMPACTA的研究地点投资了超过1500万美元的资金，用于优化员工培训，并建立全面的临床和实验室基础设施，以开展符合秘鲁和美国监管标准的多个临床研究项目。我们的使命是在四个临床研究站点(CRSS)高效和合乎道德地实施由HVTN、HPTN和ACTG提出的临床研究议程，其中三个已经与网络相关联，即Miraflres、Lince和ACSA；以及一个将加强CTU进行预防和治疗研究能力的新站点，即HNDM。特别感兴趣的领域是1)关于艾滋病毒候选疫苗或方案的第一至第三阶段临床试验，2)对未感染艾滋病毒的男男性行为者进行暴露前预防的抗逆转录病毒治疗的评估，3)减少艾滋病毒感染者中艾滋病毒危险行为的干预措施，4)使用HSV-2合并感染以减少艾滋病毒-1生殖器脱落的艾滋病毒预防试验，5)识别和干预早期/急性艾滋病毒感染的个人，以防止艾滋病毒传播或对病程的影响，6)评估新的抗逆转录病毒方案的有效性，7)评估治疗联合感染和并发症的治疗方法和治疗策略，8)根据反应的安全性、依从性、耐受性和持久性来优化抗逆转录病毒治疗。来自IMPACTA秘鲁CTU的研究人员已经作为科学委员会成员和发展方案主席为网络的研究议程做出了贡献，他们设想这个多功能CTU将全面发展成为南美洲艾滋病毒临床研究的卓越中心。 管理组件：

DESCRIPTION (provided by applicant): The proposed pluripotent IMPACTA PERU CTU is a consortium of researchers from the Asociacion Civil Impacta Salud y Educacion (IMPACTA), the Asociacion Civil Selva Amazonica (ACSA), the Hospital Nacional Dos de Mayo (HNDM), and the U.S. Naval Medical Research Center Detachment (NMRCD). The CTU headquarters are located at IMPACTA, a Non Governmental Organization devoted to HIV research, led by Dr. Jorge Sanchez and supported by a cadre of experienced researchers and promising junior investigators. It has been affiliated since year 2000 with the HIV Vaccine Trials Network (HVTN) and the HIV Prevention Trials Network (HPTN), and since 2002 with the AIDS Clinical Trials Group (ACTG). Financial support of over 15 million dollars has been invested by NIH in IMPACTA research sites during the last 5 years for optimal staff training and establishing a comprehensive clinical and laboratorial infrastructure for conducting multiple clinical research projects that meet Peruvian and U.S. regulatory standards. Our mission is to efficiently and ethically conduct the clinical research agenda proposed by HVTN, HPTN, and ACTG at four Clinical Research Sites (CRSs), three of them already network affiliated, namely Miraflores, Lince, and ACSA; and a new site that will strengthen the CTU capability to perform prevention and therapeutic research, namely the HNDM. Areas of particular interest are 1) Phase I to III clinical trials on HIV vaccine candidates or regimens, 2) evaluations of pre-exposure prophylaxis with antiretroviral treatment among uninfected men who have sex with men, 3) interventions to reduce HIV risky behaviors among HIV infected persons, 4) HIV prevention trials using treatment of HSV-2 co-infection to decrease HIV-1 genital shedding, 5) identify and intervene individuals with early/acute HIV infection to prevent HIV transmission or impact on the disease course, 6) evaluate the effectiveness of new antiretroviral regimens, 7) evaluate therapies and therapeutic strategies for treating co-infections and complications, and 8) optimize antiretroviral therapies on the basis of safety, adherence, resistance, and durability of response. Investigators from IMPACTA PERU CTU, who are already contributing to the research agenda of the networks as Scientific Committee members and as chairs of protocols in development, envision this pluripotent CTU to fully develop as a center for excellence in HIV Clinical Research in South America. ADMINISTRATIVE COMPONENT: