Phase III trial of BI 201335 in treatment naive relapser HCV-HIV coinfected patients
- Conditions
- Chronic hepatitis C infection genotype 1 in patients coinfected with HIV-1MedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2010-021734-59-IT
- Lead Sponsor
- BOEHRINGER ING.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 446
1. Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detectable HCV RNA at screening in addition to: -Positive anti-HCV antibodies or detectable HCV RNA at least 6 months prior to screening 2. HCV genotype 1 infection confirmed by genotypic testing at screening 3. HCV RNA >= 1,000 IU/ml at screening. 4. HCV Naive or HCV 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 5.Documentation of liver biopsy within 3 years or fibroscan within 6 months prior to randomisation. 6. Age 18 to 70 years. 7. Chronic HIV-1 infection confirmed by HIV-1 viral load testing at screening and documented for a period of at least 6 months prior to screening by HIV-1 viral load, or HIV-1 Western blot. 8. ARV-treatment naïve or patients on stable HAART, defined as the following -ARV-Naive: Never received combination antiretroviral therapy, or never received monotherapy with any of the allowed antiretrovirals (Appendix 10.7), or an experimental antiretroviral. Peripheral CD4 T cell count >=500 cells/mm3 at screening visit, and HIV plasma RNA <100,000 copies/mL. Note: According to judgment by the investigator ARV–naïve patients should only be enrolled if it is expected that they will not require initiation of HAART during the 8 weeks following initiation of treatment with BI 201335 and PegIFN/RBV. In the event that the patient needs to start HAART during the trial, please see Appendix 10.7 for further guidance. -Patients on stable HAART: HIV-1 plasma RNA undetectable at screening and for at least 6 months prior to initial randomisation, and including a maximum of 2 HIV VL blips during this period (see Section 5.2.3). Must be on an acceptable combination of antiretrovirals which are allowed in the study (see Appendix 10.7) for at least 8 weeks prior to randomisation; peripheral CD4 T cell count >= 200 cells/mm3 at screening visit. -Patients on an acceptable ATZ/RTV-containing HAART regimen must have total bilirubin <2.5 ULN at screening, and must participate in the intensive ATZ/RTV PK sampling. For the others criteria, referred to the protocol (sez. 3.3.2).
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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46
1. 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 (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix) 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 30 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 30 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 randomisation and throughout the treatment phase of this trial. 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 (visit 2). 13. Decompensated liver disease, or history of decompensated liver disease, as evidencedby ascites, hepatic encephalopathy, esophageal variceal bleeding, and/or laboratory. 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, homicidal ideation, bipolar disorders, mania, 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, pulmonaryhypertension, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method