Overview

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 V

Status:
Completed
Trial end date:
2013-08-01
Target enrollment:
0
Participant gender:
All
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 infected subjects, co-infected with human immunodeficiency virus-type 1, and to evaluate the number of patients with sustained virologic response (SVR) at 12 weeks after the planned end of treatment.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen R&D Ireland
Treatments:
Interferon alpha-2
Interferon-alpha
Interferons
Peginterferon alfa-2a
Ribavirin
Simeprevir
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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