Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV co-infected patients - EARLY HEP-C

Fundació Clínic per a la Recerca Biomèdica0 个研究点开始时间: 2016年7月8日最近更新: 2016年8月29日

试验速览

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•=18 years of age
•Patients with early chronic hepatitis C (Genotype 1 or 4) which is defined as chronic hepatitis C with known episode of AHC within the last 4 years including those who failed to PEG/RBV or those who never received therapy for AHC. AHC infection is diagnosed on the basis of documented HCV-RNA positivity (> 10.000 IU/mL) and anti-HCV seroconversion.
•No history of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
•Have liver disease staging assessment as follows: Fibroscan performed within 3 previous months of Day 1 of this study showing result <8 kPa
•Be HIV-1 infected, documented by any licensed rapid HIV test and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen, or plasma HIV-1 RNA viral load.
•Be on stable HIV Antiretroviral Therapy (ART) for at least 8 weeks prior to study entry using a dual NRTI backbone of tenofovir or abacavir and either emtricitabine or lamivudine PLUS raltegravir, or dolutegravir.
•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 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•< 18 years of age
•Patients with chronic hepatitis C genotypes other than 1 or 4.
•History of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
•Have liver disease staging assessment as follows: Fibroscan performed within 3 previous months of Day 1 of this study showing result > 8kPa
•Not be HIV-1 infected, documented by any licensed rapid HIV test and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen, or plasma HIV-1 RNA viral load.
•Due to known or suspected drug-drug interactions, for the purpose of this study, the use of Non Nucleoside Reverse Transcriptase Inhibitors, boosted Integrase Inhibitors or Protease Inhibitors against HIV will be not allow.

发起方

Fundació Clínic per a la Recerca Biomèdica