Phase III trial of BI 201335 in HCV-HIV coinfected patients who are treatment naive or relapser for HCV and treatment naive or on stable treatment for HIV

• Conditions: Chronic hepatitis C genotype 1 infection in patients coinfected with HIV-1; MedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-021734-59-DE
• Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-26
• Last Update Posted: 26 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 316

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 randomisation
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 <100,000 copies/mL.
•Patients on stable HAART: Must be on a stable regimen including the antiretroviral drugs listed in appendix 10.7 of the protocol for at least 6 weeks prior to initial randomization; Must have peripheral CD4 T cell count >=200 cells/mm3 at screening visit, and HIV-1 plasma RNA <40 copies/mL at screening and <50 copies/mL for at least 6 months prior to initial randomization.
7.Karnofsky score>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

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 randomisation. 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.Patients with liver cirrhosis, must have no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to randomisation. Patients with liver cirrhosis w/o appropriate results of liver imaging study as described cannot be included
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.Additional exclusion criteria pertaining to PegIFN and RBV

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified