IMPACTA PERU CLINICAL TRIALS UNIT

说明(由申请者提供)：拟议延长秘鲁艾滋病毒和结核病防治中心的首要目标是继续促进从预防到治疗艾滋病毒和结核病(结核病)的DAIDS科学研究议程的设计和实施。它建立在12年的经验和超过4300万美元的NIH投资的基础上，建立全面的临床和实验室基础设施，以设计和实施DAIDS科学研究，包括来自HVTN、HPTN、ACTG、MTN和Insight的研究，以及非网络临床试验，包括“男性预防艾滋病毒的化学预防”(Iprex)研究。美国公民教育协会和美国公民协会联盟 两家非营利性秘鲁研究机构Amazonica(ACSA)将继续在豪尔赫·桑切斯博士的领导下，在一批经验丰富的研究人员和有前途的初级研究人员的支持下继续工作。一个整合的三维(3D)矩阵组织结构包括组织职能(CTU管理和临床研究网站，CRSS)、支持职能(通过五个资源单位)和生产职能(来自DAIDS研究网络的试验)。这种3D矩阵交互作用透明、灵活、反应灵敏和适应性强；并提供高效的基础设施和资源利用，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所有研究阶段的基石。CTU建议继续在Barranco、San Miguel和ACSA CRSS进行由HVTN、HPTN、ACTG和MTN提出的临床研究议程。具体研究领域的选择是考虑到网络、研究优先事项和CRS的优势。在每一个拟议的领域，都有取得重大成就和未来作出贡献的巨大潜力的记录。CTU的目标是：1)评估男男性行为者中单独的和联合的艾滋病毒预防干预措施，重点是暴露前预防和抗逆转录病毒治疗预防；2)实施第1、2和3期临床试验，以开发直肠杀菌剂；3)评估B类艾滋病毒疫苗候选；4)在艾滋病毒和结核病流行的情况下，评估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；以及6)继续与秘鲁建立关系和有效沟通 社区和利益相关者在临床试验中推广良好的参与性实践。

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.