HIV Infection Clinical Trial
Official title:
Changes in Liver Steatosis After Switching From Efavirenz to Raltegravir Among HIV/HCV-Coinfected Patients Receiving Two Nucleoside Analogs Plus Efavirenz: The Steral Study
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.
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.
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