Individualised triple therapy using boceprevir in combination with pegylated interferon and ribavirin in HIV-positive patients with hepatitis C

Phase 1

Conditions: Chronic genotype 1 HCV coinfection in HIV-positive patients.
MedDRA version: 16.0Level: LLTClassification code 10065949Term: HCV coinfectionSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 16.0Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2012-005591-33-AT

Lead Sponsor: niversitätsklinik f. Innere Medizin III, Medizinische Universität Wien

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

• Confirmed HIV infection (anti-HIV1/2 antibody positive)
• Chronic HCV infection (anti-HCV positive, HCV-RNA detectable for >6 months)
• HCV-genotype (HCV-GT) 1 infection
• Age =18 years and =65 years
• No prior treatment with BOC/PEGIFN/RBV
• CD4+ cell count >200 cells/µL
• Stable antiretroviral therapy (ART) including tenofovir/emtricitabine (Truvada®, Gilead) and raltegravir (Isentress®, MSD) with HIV-RNA <50 copies/mL
• Valid result on transient elastography or liver biopsy within 6 months prior to enrollment

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• HCV-genotype other than HCV-GT1
• Ongoing alcohol abuse (average daily alcohol consumption >50g)
• Ongoing illicit drug abuse
• Significant cardiac disease (ejection fraction <40% at echocardiography)
• Significant pulmonary disease (COPD stage GOLD III/IV)
• Significant renal disease (serum creatinine >1.5 mg/dL)
• Cirrhotic patients (as defined by METAVIR F4 in liver biopsy or liver stiffness >12.3 kPa[1]) with decompensated liver disease (Child-Pugh stage B/C)
• Chronic liver diseases other than hepatitis C virus infection (hepatitis B virus infection: HBsAg positivity, nonalcoholic steatohepatitis, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson’s disease, alpha-1 antitrypsin deficiency, cystic fibrosis)
• Unwillingness to give written informed consent
• Pregancy and breastfeeding