Sofosbuvir/Ledipasvir for Hep C Rx in HIV/HCV Pre and Post Liver Transplant Subjects

Clinical Center

Investigators

Abstract

This muli-center U01 grant study was funded by the Division for AIDS, National Institutes of Health last year at which time the study underwent scientific review and regulatory review. We filed and received an Investigational New Drug (IND) exemption from the Food and Drug Administration (FDA) for the use of the combination sofosbuvir and ledipasvir (SOF/LDV). The protocol has undergone IRB review at University of California, San Francisco and the NIH. The clinical trials agreement was signed by UCSF and NIH. Our group continues to seek IRB approval at all other participating sites. The NIH site has undergone the initial site monitoring review and received site activation. We are currently awaiting drug distribution from UCFS and anticipate enrollment to begin by the end of this calendar year.