Response-guided triple therapy using boceprevir in combination with PEGIFN/RBV in HIV/HCV coinfected patients - HIVCOBOC-RGT

niversitätsklinik f. Innere Medizin III, Medizinische Universität Wien0 个研究点开始时间: 2013年6月18日最近更新: 2017年1月9日

试验速览

暂无简介。

•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

•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

发起方

niversitätsklinik f. Innere Medizin III, Medizinische Universität Wien