Status:
COMPLETED
A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1
Lead Sponsor:
Janssen R&D Ireland
Conditions:
Hepatitis C Virus Genotype-1
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of TMC435 along with pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in hepatitis C virus genotype-1 ...
Detailed Description
This is an open-label (all the people know the identity of the intervention), single arm (study will be conducted in a single group) clinical study, to evaluate the safety, tolerability and efficacy o...
Eligibility Criteria
Inclusion
- A liver biopsy required within 3 years prior to screening unless the patient has a contraindication for a liver biopsy
- Patients with bridging fibrosis or cirrhosis and without a liver biopsy result within 2 years prior screening must have an ultrasound taken within 2 months prior to the screening visit or during screening with no findings suspicious for hepatocellular carcinoma (HCC)
- Genotype-1 hepatitis C virus (HCV) infection
- Plasma HCV ribonucleic acid (RNA) of more than 10,000 IU per mL
- Documented human immunodeficiency virus-type 1 (HIV-1) infection at least 6 months prior to screening
Exclusion
- Patient showing evidence of hepatic decompensation (ie, history or current evidence of ascites, bleeding varices or hepatic encephalopathy, albumin serum concentration less than 3.3 gm per dL, prolonged prothrombin time \[PT\] expressed as international normalized ratio \[INR\] more than 1.5)
- Any liver disease of non-HCV etiology
- Co-infection with hepatitis B virus (hepatitis B surface antigen \[HBsAg\] positive)
- An acute HIV-1 infection; or HIV-2 infection
- Change in antiretroviral (ARV) regimen within the last 4 weeks prior screening
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT01479868
Start Date
October 1 2011
End Date
August 1 2013
Last Update
October 29 2014
Active Locations (32)
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1
Los Angeles, California, United States
2
Washington D.C., District of Columbia, United States
3
Orlando, Florida, United States
4
Atlanta, Georgia, United States