Changes in Liver Steatosis After Switching to Raltegravir in HIV/HCV Coinfection
Status:
Completed
Trial end date:
2017-01-17
Target enrollment:
Participant gender:
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.