HIV Pharmacology Data Repository

Abstract HIV Pharmacology Data Repository (HIV PDR) Clinical pharmacology is paramount to developing new therapeutic strategies for HIV treatment, prevention, and cure that are needed to end the epidemic. Since its inception in 2001, the UNC Center for AIDS Research (CFAR) Clinical Pharmacology and Analytical Chemistry (CPAC) Core has led the field in the provision of high- quality clinical pharmacology services to HIV/AIDS researchers. The CPAC Core has consolidated >75,000 unique concentration vs time (CvT) datapoints resulting from >29,000 samples collected across 482 unique studies quantifying 72 drug molecules in 10 species and 14 anatomical compartments into a single searchable data portal - the HIV Pharmacology Data Repository (HIV PDR). Pooled CvT data can be easily extracted from the HIV PDR in machine readable output, making this data portal a valuable informatic tool for sharing and exploring antiretroviral pharmacokinetic data to accelerate biomedical research discovery. We seek to maximize the HIV PDR’s scientific impact by expanding and disseminating this resource through the following aims: 1) creating new tools to catalyze data expansion, 2) demonstrating utility by promoting scientific exploration, and 3) propagating use by engaging users and characterizing their Target Product Profile (TPP). To this end we propose to apply FAIR (Findable, Accessible, Interoperable, Reusable) principles to expand CvT data archives, promote exploration, and empirically inform downstream development of the HIV PDR. We will ensure the long- term sustainability of this valuable resource by creating advisory boards to oversee the development of a robust governance plan designed to ensure regulatory compliance while meeting user needs. Finally, in performing the proposed aims, we will pioneer a data-sharing service to assist HIV/AIDS researchers in meeting the recommendations provided within the 2023 NIH Policy for Data Management and Sharing.