Changes in Liver Steatosis After Switching to Raltegravir in HIV/HCV Coinfection
Condition: HCV Coinfection; HIV Infection
MeSH terms: Coinfection; Fatty Liver
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To compare the impact of switching from efavirenz (EFV) plus two nucleoside analogs to
      rategravir (RAL) plus two nucleoside analogs versus keeping the same antiretroviral regimen
      on hepatic steatosis (HS) as measured by the controlled attenuation parameter (CAP) among
      HIV/HCV-coinfected patient.

      Secondary Trial Objective:

        1. To compare the proportion of HIV/HCV-coinfected patients with one category decrease in
           the grade of HS between patients continuing with EFV plus two nucleoside analogs and
           those switching from EFV plus two nucleoside analogs to RAL plus two nucleoside analogs.

        2. To evaluate the proportion of patients who maintain viral control (HIV RNA < 50
           copies/mL) after switching.

      Design:

      Open-label, randomized clinical trial to evaluate safety (phase IV)

      Condition:

      HIV and HCV coinfection.

      Intervention:

      Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV
      to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current
      regimen.
    

Detailed description: 
      Primary Objective:

      To compare the impact of switching from efavirenz (EFV) plus two nucleoside analogs to
      rategravir (RAL) plus two nucleoside analogs versus keeping the same antiretroviral regimen
      on hepatic steatosis (HS) as measured by the controlled attenuation parameter (CAP) among
      HIV/HCV-coinfected patient.

      Secondary Trial Objective:

        1. To compare the proportion of HIV/HCV-coinfected patients with one category decrease in
           the grade of HS between patients continuing with EFV plus two nucleoside analogs and
           those switching from EFV plus two nucleoside analogs to RAL plus two nucleoside analogs.

        2. To evaluate the proportion of patients who maintain viral control (HIV RNA < 50
           copies/mL) after switching.

      Design:

      Open-label, randomized clinical trial to evaluate safety (phase IV)

      Condition:

      HIV and HCV coinfection.

      Intervention:

      Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV
      to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current
      regimen.

      Study population and sample size HIV-infected patients with concomitant coinfection by HCV,
      as shown by detectable plasma HCV RNA, not candidates for therapy against HCV infection
      during the 48 week period of the Number of patients to recruit: 96, 48 patients per treatment
      group should be recruited.
    

Intervention name(s): Raltegravir; Efavirenz
Intervention type(s): Drug; Drug
Intervention description(s): Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen.; Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen.
Other intervention name(s): Issentres; Sustiva
Intervention MeSH terms: Efavirenz; Raltegravir Potassium
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment