120
Participants
Start Date
April 19, 2023
Primary Completion Date
September 30, 2026
Study Completion Date
March 31, 2027
Prophylaxis (P2W)
For participants enrolled in P2W arm, the initial dose of SOF/VEL will be administered to the recipient when called to the operating room for transplant (typically 1-3 hours prior to the start of surgery). Post-transplant, SOF/VEL will be continued daily for 13 days post-KT (a total of 14 doses administered).
Transmit and Treat (T&T)
For participants enrolled in T\&T arm, SOF/VEL will begin between post-KT day 0 and post-KT day 14. Participants will be clinically-prescribed DAAs once viremia is detected, and participant's insurance will be petitioned to obtain treatment as soon as possible. If insurance-provided DAAs are approved before post-KT day 14, participant will begin 12 weeks of study-provided SOF/VEL on date of insurance-provided DAAs approval. If insurance-provided DAAs are not approved by post-KT day 14, study-provided SOF/VEL will begin on post-KT day 14 and continue for 12 weeks.
RECRUITING
NYU Langone Health, New York
RECRUITING
Icahn School of Medicine at Mount Sinai, New York
RECRUITING
Johns Hopkins University, Baltimore
RECRUITING
Virginia Commonwealth University, Richmond
RECRUITING
University of Wisconsin, Madison, Madison
RECRUITING
University of Utah Medical Center, Salt Lake City
RECRUITING
University of California San Diego, La Jolla
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Johns Hopkins University
OTHER