IMPACTA PERU CLINICAL TRIALS UNIT

描述（由申请人提供）：IMPACTA秘鲁CTU拟议更新的总体目标是继续为DAIDS科学研究议程的设计和实施做出贡献，从艾滋病毒和结核病（TB）的预防到治疗。它建立在12年的经验和超过4300万美元的美国国立卫生研究院的投资，以建立全面的临床和实验室基础设施，设计和实施DAIDS科学研究，包括HVTN，HPTN，ACTG，MTN和INSIGHT，以及非网络临床试验，包括“男性艾滋病毒预防的化学预防”（iPrEx）研究。民间影响健康和教育协会与民间森林协会之间的联合会 亚马逊（阿克萨），两个非营利性的秘鲁研究组织，将继续在豪尔赫桑切斯博士的领导下，并由一个有经验的研究人员和有前途的初级研究人员骨干的支持。一个统一的三维（3D）矩阵组织结构整合了组织功能（CTU管理和临床研究中心，CRS），支持功能（通过五个资源单位）和生产功能（DAIDS研究网络的试验）。这种3D矩阵相互作用是透明的，灵活的，反应灵敏的和适应性强的;并提供了基础设施和资源的有效利用，避免冗余，提供集中服务，共享战略和优化成本控制。两个成熟的社区咨询委员会是社区成功参与研究各个阶段的基石。CTU建议继续在Barranco、San Miguel和阿克萨CRS开展HVTN、HPTN、ACTG和MTN提出的临床研究议程。研究的具体领域已经选择考虑到网络的研究重点和CRS的优势。在每一个拟议领域，都有取得重大成就和今后作出贡献的巨大潜力的记录。反恐组的目标是：1）评价男男性行为者中的单独和联合艾滋病毒预防干预措施，重点是暴露前预防和预防性抗逆转录病毒治疗; 2）实施1、2和3期临床试验，以开发直肠杀微生物剂; 3）评价分支B艾滋病毒候选疫苗; 4）在艾滋病毒和结核病流行的环境中，评价针对这两种疾病的新型治疗干预措施; 5）保持最高标准的资源管理，以有效和及时地实施临床试验; 6）继续与秘鲁政府建立关系和有效沟通。 社区和利益相关者在临床试验中促进良好的参与性实践。

DESCRIPTION (provided by applicant): The overarching goal of the proposed renewal of the IMPACTA PERU CTU is to continue contributing to the design and implementation of the DAIDS scientific research agenda, across the continuum from prevention to treatment of HIV and tuberculosis (TB). It builds upon 12 years of experience and over $43 million of NIH investment to establish comprehensive clinical and laboratorial infrastructure for designing and implementing DAIDS scientific research studies, including those from the HVTN, HPTN, ACTG, MTN and INSIGHT, as well as non-network clinical trials, including the "Chemoprophylaxis for HIV Prevention in Men" (iPrEx) study. The consortium between the Asociacion Civil Impacta Salud y Educacion and the Asociacion Civil Selva Amazonica (ACSA), two nonprofit Peruvian research organizations, will continue under the leadership of Dr. Jorge Sanchez and supported by a cadre of experienced researchers and promising junior investigators. A consolidated three dimensional (3D) matrix organizational structure integrates organizational functions (CTU governance and Clinical Research Sites, CRSs), support functions (through five resource units) and production functions (trials from DAIDS research networks). This 3D matrix interplay is transparent, flexible, responsive and adaptable; and provides efficient utilization of infrastructure and resources avoiding redundancies, providing centralized services, sharing strategies and optimizing cost containment. Two mature Community Advisory Boards are the cornerstone for the successful community participation in all stages of research. The CTU proposes to continue conducting the clinical research agenda proposed by the HVTN, HPTN, ACTG and MTN, at Barranco, San Miguel and ACSA CRSs. The specific areas of research have been chosen considering the networks research priorities and CRS strengths. In each proposed area, there is a track record of significant accomplishments and great potential for future contribution. The CTU aims to: 1) evaluate individual and combination HIV prevention interventions among men who have sex with men, with focus on pre-exposure prophylaxis and antiretroviral treatment for prevention; 2) implement Phase 1, 2, and 3 clinical trials to develop rectal microbicides; 3) evaluate vaccine candidates for clade B HIV; 4) evaluate novel therapeutic interventions targeting HIV and TB, in a setting where both diseases are prevalent; 5) maintain the highest standards of resource management for efficient and timely implementation of clinical trials; and 6) continue building relationships and effective communications with the Peruvian community and stakeholders promoting good participatory practices in clinical trials.