The HIV pandemic is one of the greatest ongoing threats to health and development, over 35 years past its recognition. The NIAID-funded Clinical Trials Networks have played critical roles in the coordinated response to key research questions in the HIV/AIDS field, which will contribute to ultimately ending the HIV epidemic. The Vanderbilt HIV Clinical Trials Unit (CTU) will continue the established partnership between Vanderbilt University Medical Center in Nashville, Tennessee, and Washington University in St. Louis, Missouri, which are located in a region of the United States with high incidence and prevalence of HIV. This CTU comprises three highly productive Clinical Research Sites (CRSs) that contribute to three Networks - the therapeutics mission of the AIDS Clinical Trials Group (ACTG), the vaccine mission of the HIV Vaccine Trials Network (HVTN), and the non- vaccine prevention mission of the HIV Prevention Trials Network (HPTN). The Vanderbilt Vaccine CRS and Washington University Therapeutics CRS have been members of the HVTN and ACTG since the inception of these Networks in 1987-1988. The Vanderbilt Therapeutics CRS joined the ACTG in 2000. To contribute more broadly to the Networks, Washington University has provided protocol-specific enrollment to the HPTN since 2016, and proposes to become a full member site of the HPTN, as the Washington University Prevention & Therapeutics CRS. Leaders of this CTU have made high-impact scientific and programmatic contributions to the Networks in areas that include human genomics, contemporary HIV-associated comorbidities, neurological aspects of HIV disease, immunology of vaccine response, and beyond. During the proposed funding period, the Vanderbilt CTU will continue to make substantial contributions to the ACTG, HVTN and HPTN's scientific priorities. ACTG sites at both Vanderbilt and Washington University will focus on strategies to improve the health of people living with HIV/AIDS, tuberculosis, and viral hepatitis. The Vanderbilt HVTN site will contribute both study participants and cutting-edge immunologic technologies to further the major scientific priority of developing and testing a safe and effective vaccine for HIV. The Washington University site will additionally contribute to HPTN's emphasis on long-acting agents for pre-exposure prophylaxis, developing multipurpose technologies such as combining HIV prevention with contraception, and strategies integrating biomedical, behavioral and structural interventions for prevention. All CRSs of this CTU have an established record of success in enrolling participants to clinical trials and conducting studies with utmost fidelity to ensure participant safety and quality data advancing the science of HIV treatment and prevention.

Public Health Relevance

The HIV pandemic is an immense threat to health and development. This Clinical Trials Unit, that partners Vanderbilt University Medical Center and Washington University at St Louis, will contribute to the missions of the AIDS Clinical Trials Group, HIV Vaccine Trials Network, and HIV Prevention Trials Network.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Special Emphasis Panel (ZAI1)
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Germuga, Donna E
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Vanderbilt University Medical Center
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