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 has recently been funded by the Division for AIDS, National Institutes of Health. This year we have undergone scientific review and regulatory review. We have 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. Our group continues to work on the clinical trials agreement and IRB approval at all other participating sites. We anticipate enrollment to begin by the end of this calendar year.