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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03413696 -
Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
|
||
| Completed |
NCT03740906 -
Direct-acting Antiviral Therapy and Reinfection Among People With Chronic Hepatitis C Virus Infection and Recent Injecting Drug Use in the Prison Setting
|
||
| Terminated |
NCT02465203 -
3-year Follow-up Study to Assess the Viral Activity in Hepatitis C Patients Who Failed Feeder DEB025/Alisporivir Study
|
Phase 3 | |
| Completed |
NCT02262728 -
An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease
|
Phase 2 | |
| Completed |
NCT01429792 -
A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
|
Phase 4 | |
| Completed |
NCT02541409 -
Directly Observed Therapy for HCV in Chennai, India
|
Phase 2 | |
| Completed |
NCT01846832 -
A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection
|
Phase 3 | |
| Withdrawn |
NCT01608737 -
A Phase III Study of BI201335 in Treatment-naive and Prior Relapser Patients With Chronic Hepatitis C Infection
|
Phase 3 | |
| Completed |
NCT01435226 -
GS-5885, GS-9451, Tegobuvir and Ribovirin in Treatment-Experienced Subjects With Chronic Genotype 1a Or 1b Hepatitis C Virus (HCV) Infection
|
Phase 2 | |
| Completed |
NCT02113631 -
Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir
|
N/A | |
| Completed |
NCT01447446 -
An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C
|
N/A | |
| Completed |
NCT01435044 -
Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection
|
Phase 2 | |
| Completed |
NCT01399619 -
Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)
|
Phase 3 | |
| Terminated |
NCT01168856 -
An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens
|
N/A | |
| Completed |
NCT00725751 -
Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)
|
N/A | |
| Completed |
NCT00793793 -
Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced
|
Phase 1 | |
| Completed |
NCT00375661 -
Low-dose Peg-interferon Plus Ribavirin (IFN/RBV) for Prevention of Hepatocellular Carcinoma (HCC) Recurrence in Patients Who Had Surgery to Remove Primary HCC
|
Phase 4 | |
| Completed |
NCT00377182 -
A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.
|
Phase 2 | |
| Completed |
NCT00217139 -
A Study to Evaluate the Safety and Efficacy of Celgosivir and Peginterferon Alfa-2b, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype 1 Infection
|
Phase 2 | |
| Completed |
NCT00723632 -
Pharmacoeconomic Study Assessing the Cost of Chronic Hepatitis C Treatment With Peginterferon Alfa-2b (PegIntron) and Ribavirin (Rebetol) in the Czech Republic (Study P04588)(COMPLETED)
|
N/A |