Pitt-Ohio State Clinical Trials Unit

Project Summary The Pitt-Ohio State Clinical Trials Unit (Pitt-OSU CTU), and its two Clinical Research Sites (CRSs) at the University of Pittsburgh (Pitt CRS) in Pittsburgh, PA, and The Ohio State University (OSU CRS) in Columbus, Ohio, is a high performing CTU that is vital for both scientific and administrative leadership in the DAIDS networks for HIV Therapeutics and HIV Prevention. The Pitt-OSU CTU proposes to continue its productive affiliations with the AIDS Clinical Trials Group (ACTG) and the HIV Prevention Trials Network (HPTN). Additionally, the Pitt-OSU CTU is poised to expand further in terms of scientific capabilities and access to both affected and at risk populations to participate in the HIV Vaccine Trials Network (HVTN). As such, the Pitt-OSU CTU will contribute to the research agendas of several DAIDS HIV/AIDS Clinical Trials Networks and thereby achieve the desired efficiency for a CTU. The Aims of this application are: 1) to continue to advance the scientific agenda of the DAIDS HIV/AIDS Therapeutic and Prevention networks by developing and implementing high-priority research studies as key protocol team members, by serving on major network leadership and scientific committees, and by directing the ACTG Laboratory Center (LC) Virology and Immunology Specialty Laboratories; 2) to recruit, enroll, retain and monitor study participants in high-priority protocols of the DAIDS networks, and to meet and exceed performance standards established by these networks; 3) to engage with partners in our communities, including Columbus, Ohio, located in Franklin County (one of the 48 counties in the US with the highest HIV burden) to support implementation science initiatives consistent with the national “Ending the HIV Epidemic Plan”; 4) to partner with affected communities and community advisory boards at each CRS throughout these endeavors; and 5) to mentor young investigators identified at each CRS to become skilled, independent researchers. The key scientific areas of focus in HIV therapeutics will include HIV reservoirs and control of HIV replication in the absence of ART (“ART-free remission”); novel and long-acting interventions for the treatment of HIV; and prevention and treatment of HIV-related non-infectious co-morbidities and Hepatitis B. In HIV Prevention, the Pitt-OSU CTU will utilize skills and expertise developed over the past decade to focus on long- acting antiretroviral agents and delivery systems for Pre-exposure Prophylaxis (PrEP); evaluation of multipurpose prevention technologies (MPTs) and broadly neutralizing antibodies for HIV prevention; and integrated strategies for HIV prevention. The collective expertise, administrative efficiency, and performance record of the Pitt-OSU CTU and its CRSs over the last grant cycle ensure that these Specific Aims are achievable and that the Pitt-OSU CTU will make important contributions to the research agendas of DAIDS-sponsored networks, with the ultimate goal of ending the AIDS epidemic.