PERU Clinical Trial Unit

秘鲁临床试验单位

• 批准号: 10057249
• 负责人: Alberto La Rosa
• 金额: $ 406.71万
• 依托单位: ASOCIACION CIVIL IMPACTA SALUD Y EDUCACN
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-20 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10057249
• 关键词: 3-Dimensional; AIDS clinical trial group; AIDS prevention; AIDS/HIV problem; Address; Anti-Retroviral Agents; Antibodies; Area; Caring; Clinical; Clinical Trials; Clinical Trials Network; Clinical Trials Unit; Combined Vaccines; Communication; Communities; Community Participation; Conduct Clinical Trials; Cost Control; Country; Disease; Drug Formulations; Drug Interactions; Drug resistance; Drug resistance in tuberculosis; Ensure; Epidemic; Ethics; Funding; Future; Generations; Goals; Grant; HIV; HIV Infections; HIV Vaccine Trials Network; HIV prevention trials network; HIV vaccine; HIV-1; HIV/TB; Human Resources; Incidence; Individual; Infrastructure; Intervention; Investments; Meningeal Tuberculosis; Morbidity - disease rate; Peru; Peruvian; Pharmaceutical Preparations; Phase; Positioning Attribute; Prevention; Principal Investigator; Production; Protocols documentation; Publications; Recurrence; Relationship-Building; Research; Research Infrastructure; Research Personnel; Research Priority; Resistance; Resources; Safety; Services; Structure; System; Testing; Time; Toxic effect; Tuberculosis; United States National Institutes of Health; Vulnerable Populations; base; clinical practice; clinical research site; clinical trial implementation; cohesion; community engagement; comorbidity; design; experience; flexibility; high standard; implementation intervention; improved; innovation; laboratory experience; member; men who have sex with men; mortality; novel; novel therapeutic intervention; operation; organizational structure; pre-exposure prophylaxis; prevent; preventive intervention; research study; resistant strain; response; tool; transgender women; treatment optimization; tuberculosis treatment; vaccine candidate; vaccine evaluation

Project Summary/Abstract The overarching goal of the proposed renewal of the PERU CTU is to continue contributing to the design and implementation of the NIH HIV/AIDS clinical trial networks research agenda, across the continuum from prevention to treatment of HIV and tuberculosis (TB). It builds upon 19 years of experience and over $110 million of NIH investment to establish a comprehensive clinical and laboratorial infrastructure for designing and implementing network research studies, including those from the HVTN, HPTN, ACTG, MTN and INSIGHT, as well as several non-network clinical trials. The consortium is led by Asociacion Civil Impacta Salud y Educacion (IMPACTA) and is also composed by the Centro de Investigaciones Tecnologicas, Biomedicas y Medioambientales (CITBM), the Asociacion Civil Selva Amazonica (ACSA) and the Asociación Via Libre. Multiple principal investigators are Dr. Jorge Sanchez (based at CITBM) and Dr. Alberto La Rosa (based at IMPACTA) 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 four resource units) and production functions (local teams leading specific trials). This 3D matrix interplay allows for operations that are cohesive, synergistic, integrated, transparent, flexible, responsive and adaptable. It 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 successful community participation in all stages of research. The PERU CTU proposes to continue conducting the networks research agenda at five CRSs: ACSA (HPTN, HVTN), Barranco (HVTN, ACTG), CITBM (HPTN, HVTN), San Miguel (ACTG, HPTN), and Via Libre (HVTN, HPTN). The specific areas of research proposed for the next grant cycle have been chosen considering both the networks research priorities and our CRS strengths. In each area, there is a track record of significant accomplishments and great potential for future contributions. The CTU aims to: 1) evaluate individual and combination vaccine and non-vaccine HIV prevention interventions among men who have sex with men and transgender women; 2) evaluate novel therapeutic interventions targeting HIV and strategies to address toxicities, drug-drug interactions, and comorbidities; 3) improve the prevention and treatment of tuberculosis; 4) maintain the highest standards of resource management for efficient and timely implementation of clinical trials; and 5) continue building relationships and effective communications with the Peruvian community and stakeholders promoting good participatory practices in clinical trials. These feasible aims, our increasing capacity to conduct clinical trials and our ability to adapt to challenges, uniquely position the PERU CTU to continue contributing towards an HIV/AIDS- and TB-free generation.

项目概要/摘要 秘鲁 CTU 拟议更新的总体目标是继续为设计和 NIH HIV/AIDS 临床试验网络研究议程的实施 它建立在 19 年的经验和超过 1.1 亿美元的基础上。 NIH 投资建立全面的临床和实验室基础设施，用于设计和 实施网络研究，包括来自 HVTN、HPTN、ACTG、MTN 和 INSIGHT 的研究， 该联盟由 Asociacion Civil Impacta Salud y Educacion 领导。 (IMPACTA)，也由 Centro de Investigaciones Tecnologicas、Biomedicas y 组成 Medioambientales (CITBM)、Asociacion Civil Selva Amazonica (ACSA) 和 Asociacion Via Libre。 多名主要研究者包括 Jorge Sanchez 博士（来自 CITBM）和 Alberto La Rosa 博士（来自 CITBM） IMPACTA）并得到了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。 统一的三维（3D）矩阵组织结构整合了组织职能（CTU 治理和临床研究中心 (CRS)、支持功能（通过四个资源单位）和生产 功能（领导特定试验的本地团队）这种 3D 矩阵相互作用允许有凝聚力的操作， 它协同、集成、透明、灵活、响应迅速且适应性强。 基础设施和资源，避免冗余，提供集中服务，共享策略和 优化成本控制。两个成熟的社区咨询委员会是成功的基石。 秘鲁 CTU 建议继续开展该网络的社区参与。 五个 CRS 的研究议程：ACSA（HPTN、HVTN）、Barranco（HVTN、ACTG）、CITBM（HPTN、HVTN）、San Miguel（ACTG、HPTN）和 Via Libre（HVTN、HPTN）提出了下一次资助的具体研究领域。 周期的选择考虑了网络研究重点和我们 CRS 在每个领域的优势。 CTU 的目标是取得重大成就和巨大潜力。 1) 评估男性中的个体和组合疫苗和非疫苗艾滋病毒预防干预措施 与男性和变性女性发生性行为的人；2) 评估针对艾滋病毒和变性者的新型治疗干预措施 解决毒性、药物相互作用和合并症的策略；3) 改善预防和治疗； 4) 维持最高标准的资源管理，以实现高效、及时的治疗 实施临床试验；以及 5) 继续与相关机构建立关系和有效沟通 秘鲁社区和利益相关者促进临床试验中的良好参与实践。 目标、我们不断增强的临床试验能力和适应挑战的能力、独特的地位 秘鲁 CTU 继续为无艾滋病毒/艾滋病和结核病的一代做出贡献。