Chronic hepatitis C infection genotype 1 in patients coinfected with HIV-1 MedDRA version: 20.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Boehringer Ingelheim Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chronic hepatitis C infection with HCV genotype 1. 2. Chronic HIV -1 infection 3. HCV treatment-Naive or HCV treatment relapser defined as the following: • Treatment-naïve to interferon, pegylated interferon and ribavirin, or • Prior relapser: Undetectable HCV RNA (based on an assay considered sensitive at the time of treatment) at the end of treatment with a pegylated interferon-based regimen, but HCV RNA detectable within 24 weeks of treatment follow up 4. Documentation of liver biopsy within 3 years or fibroscan within 6 months prior to screening visit 5. Age 18 to 70 years. 6. ARV-treatment naïve or patients on stable HAART, defined as the following • ARV-Naive: Never received combination antiretroviral therapy, or never received monotherapy with raltegravir-, or elvitegravir, or an experimental antiretroviral. Must have peripheral CD4 T cell count >=500 cells/mm3 at screening visit, and HIV-1 plasma RNA =200 cells/mm3 at screening visit, and HIV-1 plasma RNA 70 8. No AIDS-defining illness during 6 months prior to screning. 9. Female patients who are infertile or who are of childbearing potential with a negative pregnancy test and agreeing to use one accepted method of birth control in addition to the use of a condom by their male partners, or Male patients who are infertile, who are without pregnant female partners or who consistently and correctly use condoms 10. Signed Informed Consent Form Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 290 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening. 2.Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. Incidential steatosis diagnosed by biopsy is not considered evidence of liver disease. 3.Hepatitis B virus (HBV) infection with presence of HBs-Ag. 4.Active malignancy, or history of malignancy within the last 5 years prior to screening 5. Active or history of alcohol or illicit drug abuse other than cannabis within the past 12 months. 6.A condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, influence the results of this study, or limit the patient’s ability to participate in this study. 7. Usage of any investigational drugs within 28 days prior to screening, or planned usage of an investigational drug during the course of this study. 8 Received concomitant systemic antiviral (other than antiretroviral), hematopoietic growth factor, or immunomodulatory treatment within 28 days prior to enrolment. Patients being treated with oral antivirals such as acyclovir, famcilovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be enrolled. 9.Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to enrolment. 10.Patients who have been previously treated with at least one dose of any antiviral or inmunomodulatory drug other than interferon alfa or ribavirin for acute or chronic HCV infection including and not restricted to protease or polymerase inhibitors. 11. Known hypersensitivity to any ingredient of the study drugs. 12 Alpha fetoprotein value >100 ng/mL at screening; if > 20 ng/mL and = 100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to randomisation. 13. Decompensated liver disease, or history of decompensated liver disease, as evidenced by ascites, hepatic encephalopathy, esophageal variceal bleeding, and/or laboratory values which add up to > 7 points according to the Child-Turcotte-Pugh (CTP) classification. 14. Patients with stable cardiac disease and Hemoglobin <12 g/dL. 15. Pre-existing psychiatric condition that could interfere with the subject’s participation in and completion of the study including but not limited to prior suicidal attempt, schizophrenia, major depression syndrome, severe anxiety, severe personality disorder, a period of disability or impairment due to a psychiatric disease within the past 5 years. 16. Clinical evidence of significant or unstable cardiovascular disease, including angina, myocardial infarction within 6 months, pulmonary hypertension, cardiomyopathy, congestive heart failure, uncontrolled hypertension, significant arrhythmia or clinically significant abnormalities on ECG at screening. 17. Clinical evidence of chronic pulmonary disease (e.g. chronic obstructive pulmonary disease) associated with functional impairment. 18 Active autoimmune disease, including autoimmune hepatitis. 19. History or evidence of retinopathy or clinically significant ophthalmological disorder including diabetic or hypertensive retinopathy, retinal haemorrhages, cotton wool spots, papilloedema, optic neuropathy, or retinal artery/vein obstruction. An eye examination performed within 6 months p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective: The objective of this trial is to evaluate the safety and efficacy of an open-label treatment with BI 201335 240 mg once daily given for 12 or 24 weeks in combination with pegylated interferon-a2a and ribavirin given for 24 or 48 weeks in HCV/HIV coinfected patients, who are HCV-treatment naive or HCV-treatment relapsers and HIV treatment-naïve- or, who are being treated with Raltegravir/Truvada® therapy for HIV infection. Results of this trial will be compared with historical efficacy and safety data of randomized trials of 48 weeks of treatment with pegylated interferon-a 2a and ribavirin for HCV GT 1 infection in HIV/HCV co-infected patients.;Secondary Objective: Secondary objectives: evaluate the safety of the BI 201335 240mg once daily in combination with pegylated interferon-a 2a and ribavirin in the population of HIV/HCV co-infected patients;Primary end point(s): Sustained Virological Response (SVR): Plasma HCV RNA level <25 IU/mL, undetected 24 weeks after the planned treatment duration.;Timepoint(s) of evaluation of this end point: 24 weeks after the originally planned treatment duration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Virological response after 12 weeks of treatment discontinuation (SVR12): Plasma HCV RNA level < 25 IU/mL, (undetected) 12 weeks after the originally planned treatment duration. • ALT normalization: ALT in normal range 24 weeks after the end of the originally planned treatment duration. • Early Treatment Success (ETS): Plasma HCV RNA level<25 IU/mL (detected or undetected) at Week 4 and HCV RNA <25 IU/m (undetected) at Week 8. ; Timepoint(s) of evaluation of this end point: • 12 weeks of treatment discontinuation • 24 weeks after end of the originally planned treatment duration • At week 4 and week 8 | — |
Countries
Brazil, France, Germany, Italy, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed