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Sofosbuvir Based DAA Therapy in HIV/HCV Coinfected Pre or Post Liver Transplant — STOP-CO  

HIV Clinical Trial

Official title:
A Retrospective/Prospective Cohort Study to Assess Safety, Tolerability, and Efficacy of Sofosbuvir Based Direct Acting Antiviral (DAA) Therapy for Hepatitis C Treatment in HIV/HCV Coinfected Subjects Pre or Post Liver Transplant

Clinical Trial Summary

Retrospective/Prospective, open-label study using sofosbuvir based DAA therapy to treat HIV/HCV coinfected pre or post liver transplant participants

Clinical Trial Description

Approximately fifty HIV/HCV coinfected patients with decompensated liver disease will be enrolled in the study. Ten (up to twenty) subjects will be treated with FDC SOF/LDV pre or post liver transplant and followed prospectively. Forty + subjects will be enrolled retrospectively with the intent to capture all patients who have been exposed to sofosbuvir based DAA therapies at participating sites since 1/2014, and to mirror the population being enrolled prospectively. In addition, participants in the retrospective arm will be contacted to consent to one prospective study visit for liver staging to determine rates of reversal of decompensation, reversal of cirrhosis and improvements in graft survival post treatment, and for future contact by the NIH Clinical Center to assess longer term outcomes when this study ends. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02533934
Study type Interventional
Source University of California, San Francisco
Contact
Status Completed
Phase Phase 4
Start date August 2016
Completion date December 31, 2019
View Details
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