Changes in Liver Steatosis After Switching to Raltegravir in HIV/HCV Coinfection

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.

Timeline

Start

2014-02-03

Primary completion

2017-01-17

Completion

2017-01-17

Publications

• Macias J, Mancebo M, Merino D, Tellez F, Montes-Ramirez ML, Pulido F, Rivero-Juarez A, Raffo M, Perez-Perez M, Merchante N, Cotarelo M, Pineda JA; Spanish AIDS Research Network-HEP09 Study Group. Changes in Liver Steatosis After Switching From Efavirenz to Raltegravir Among Human Immunodeficiency Virus-Infected Patients With Nonalcoholic Fatty Liver Disease. Clin Infect Dis. 2017 Sep 15;65(6):1012-1019. doi: 10.1093/cid/cix467.

Drugs

Indications