NCT02206932

A Study of the Safety and Effectiveness of Simeprevir and Sofosbuvir for Patients With HIV and Hepatitis C

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hepatitis C, Chronic
• HIV CDC Category A1

Interventions

Type	Name	Description
DRUG	Sofosbuvir + Simeprevir

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-09-01
• Completion: 2015-12-01
• First posted: 2014-08-01
• Last updated: 2019-06-13

Locations

1 site across 1 country: United States