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Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV Co-infected Patients (NCT02897596)

Evaluate the efficacy of 12 or 8 weeks treatment with Grazoprevir/Elbasvir in Early Chronic Hepatitis C GT1,4 in HIV co-infected patients and evaluate the safety and tolerability of Grazoprevir + Elbasvir in HIV-HCV co-infected patients.
  • Drug: Grazoprevir 100 mg/d 8 weeks
    Patients with 1b HCV genotype will be received treatment with Grazoprevir (100 mg) during 8 weeks.
    • MK-5172 100 mg
  • Drug: Elbasvir 50 mg/d 8 weeks
    Patients with 1b HCV genotype will be received treatment with Elbasvir (50mg) during 8 weeks.
    • MK-8742 50 mg
  • Drug: Grazoprevir 100 mg/d 12 weeks
    Patients with 1a or 4 HCV genotype will be received treatment with Grazoprevir (100 mg) during 12 weeks.
    • MK-5172 100 mg
  • Drug: Elbasvir 50 mg/d 12 weeks
    Patients with 1a or 4 HCV genotype will be received treatment with Elbasvir (50mg) during 12 weeks.
    • MK-8742 50 mg
Ages eligible for Study
18 Years and older
Genders eligible for Study
All
Accepts Healthy Volunteers
No
Inclusion Criteria:
  • ≥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
Exclusion Criteria:
  • < 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, Inhibitors or Protease Inhibitors against HIV will be not allow.
Genotype 1b: 8 weeks treatment with Grazoprevir/Elbasvir

Genotype 1a and 4: 12 weeks treatment with Grazoprevir/Elbasvir
Status:
not yet recruiting
Type:
Interventional
Phase:
Start:
31 August, 2016
Updated:
06 September, 2016
Participants:
62
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