THE IMPACTA PERU CLINICAL TRIALS UNIT

描述（由申请人提供）：提议的多能IMPACTA PERU CTU是一个由来自民间影响健康教育协会（IMPACTA）、民间亚马孙雨林协会（ACSA）、国家多斯医院（HNDM）和美国海军医学研究中心支队（NMRCD）的研究人员组成的联盟。CTU总部位于IMPACTA，这是一个致力于艾滋病研究的非政府组织，由Jorge Sanchez博士领导，由一群经验丰富的研究人员和有前途的初级研究人员支持。自2000年以来，它加入了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组（ACTG）。在过去的5年里，美国国立卫生研究院在IMPACTA研究基地投入了超过1500万美元的财政支持，用于最佳的员工培训和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）高效和道德地执行HVTN， HPTN和ACTG提出的临床研究议程，其中三个已经是网络附属，即Miraflores， Lince和ACSA；以及一个新的地点，将加强CTU进行预防和治疗研究的能力，即HNDM。特别感兴趣的领域有：1)艾滋病毒候选疫苗或方案的一至三期临床试验；2)对未感染的男男性行为者进行抗逆转录病毒治疗的暴露前预防评估；3)减少艾滋病毒感染者的艾滋病毒风险行为的干预措施；4)利用治疗单纯疱疹病毒-2合并感染来减少艾滋病毒-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体，以预防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)评估治疗合并感染和并发症的疗法和治疗策略，以及8)在安全性、依从性、耐药性和反应持久性的基础上优化抗逆转录病毒疗法。IMPACTA秘鲁CTU的研究人员已经作为科学委员会成员和开发方案主席为网络的研究议程做出了贡献，他们设想这个多能CTU将充分发展成为南美洲艾滋病临床研究的卓越中心。

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: