The FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit.

FioTrials摘要 FioTrials CTU总部设在奥斯瓦尔多·克鲁兹基金会(巴西里约热内卢)，由Dr。 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。 FioTrials隶属于Fiocruz，该中心是公共卫生和卫生领域的国际卓越中心 传染病。FioTrials CTU促进和奖励创新，同时提供标准化、 临床试验实施和管理的正式方法。CTU已经成功地 为NIH赞助的多个网络实施并进行了关键临床试验，这些网络改变了 过去14年艾滋病毒和结核病(结核病)预防和治疗情况。菲奥特莱斯 临床研究网站(CRS)，埃万德罗·查加斯临床研究所(IPEC CRS)创建了一个 在以医院为基础的环境下进行临床研究方面的广泛成就记录，并 不断被证明是CRS的精英表演者。IPEC CRS致力于确保其所有 流程和标准符合或取代DAIDS赞助的网络、ICH/GCP的要求 标准，以及其他监管机构。CRS不仅有助于产生以下结果 改善了对艾滋病毒、结核病和肝炎感染者和受影响者的护理和治疗， 它们相关的共生关系，但也适用于11种新型药物的许可证申请。FioTrials CTU IPEC CRS已成功通过美国(FDA)和欧洲的监管检查 (EMA)当局。FioTrials和IPEC CRS与当地艾滋病毒/艾滋病建立了牢固的关系 和LGBTQI+社区。我们的项目成功是动态和协作过程的结果， 不同的利益相关者，如研究参与者和社区、社区领导人和倡导者， 非政府组织、研究人员、相关政府机构和卫生保健提供者。这个 CTU和CRS团队由具有不同社会和专业背景的个人和研究人员组成 背景，性别，性取向，种族，信仰和价值观，很好地代表了我们的社区 发球。在下一个供资周期中，我们期待着有机会为科学和 ACTG、HPTN和HVTN网络的功能目标。与我们的DAIDS网络合作伙伴一起，我们致力于 加强艾滋病毒、结核病和肝炎的治疗和预防。

FioTrials Abstract The FioTrials CTU, based at the Oswaldo Cruz Foundation - FIOCRUZ (Rio de Janeiro, Brazil), is led by Dr. Beatriz Grinsztejn and supported by a cadre of experienced researchers and promising junior investigators. FioTrials is affiliated with FIOCRUZ, an international center of excellence in the field of public health and infectious diseases. The FioTrials CTU promotes and rewards innovation, while providing a standardized, formal approach to the implementation and management of clinical trials. The CTU has successfully implemented and conducted pivotal clinical trials for multiple NIH-sponsored Networks that have changed the landscape of HIV and Tuberculosis (TB) prevention and treatment during the last 14 years. The FioTrials Clinical Research Site (CRS), Instituto de Pesquisa Clinica Evandro Chagas (IPEC CRS), has created an extensive record of accomplishment in conducting clinical research at a hospital-based setting and has continuously proven to be an elite performer CRS. The IPEC CRS is committed to ensuring that all of its processes and standards meet or supersede the requirements for DAIDS-sponsored networks, ICH/GCP standards, and other regulatory authorities. The CRS has not only contributed to the generation of results that led to improved care and treatment for those infected with and affected by HIV, tuberculosis, and hepatitis and their associated comorbidities, but also to the licensure applications for 11 novel agents. The FioTrials CTU and the IPEC CRS have successfully undergone regulatory inspections from both US (FDA) and European (EMA) authorities. FioTrials and the IPEC CRS have established a solid relationship with the local HIV/AIDS and LGBTQI+ communities. Our program success is the result of a dynamic and collaborative process with different stakeholders, such as study participants and communities, community leaders and advocates, nongovernmental organizations, researchers, relevant governmental bodies, and health care providers. The CTU and CRS teams are composed of individuals and researchers with diverse social and professional backgrounds, gender, sexual orientation, race, beliefs, and values that well represent the communities we serve. During this next funding cycle, we look forward to the opportunity to contributing to the scientific and functional goals of the ACTG, HPTN, and HVTN networks. Together with our DAIDS Network partners, we aim to enhance the landscape for HIV, TB, and Hepatitis treatment and prevention.