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

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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.