Hepatitis C, Chronic Clinical Trial
Official title:
An Open Label, Pilot Study to Investigate the Safety and Efficacy of 12 Weeks of Simeprevir and Sofosbuvir, for HIV-infected, HCV Genotype 1 Patients With Advanced Fibrosis
This is a study of the safety and effectiveness of the hepatitis C medications sofosbuvir and simeprevir in patients who have both the HIV and hepatitis C (HCV) viruses.
This is a research study of an investigational combination of two hepatitis C medications
call sofosbuvir (SOF) and simeprevir (SMV). Both medications are approved by the U.S. Food
and Drug Administration (FDA) for treatment of hepatitis C in combination with other
medications. The combination sofosbuvir and simeprevir has not been approved by the FDA and
is being tested as an investigational combination in research studies such as this. The
purpose of this study is to see if SOF + SMV given for 12 weeks is safe and able to clear the
Hepatitis C virus (HCV) from subjects who are co-infected with HIV-1 and who have scarring of
the liver (fibrosis of 3 or 4 on a scale of 0-4, with 4 as the most scarring, also known as
cirrhosis).
This study is an investigator-initiated clinical trial sponsored by University of California,
San Francisco (UCSF), with support and the study drug simeprevir provided by Janssen
Scientific Affairs, LLC.
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