Ignite Creation Date:
2024-05-06 @ 1:49 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01900015
Status:
COMPLETED
Last Update Posted:
2017-07-25
First Post:
2013-07-12
Brief Title:
Changes in Liver Steatosis After Switching to Raltegravir in HIVHCV Coinfection
Sponsor:
Juan Macías
Organization:
Andaluz Health Service
Study Overview
Official Title:
Changes in Liver Steatosis After Switching From Efavirenz to Raltegravir Among HIVHCV-Coinfected Patients Receiving Two Nucleoside Analogs Plus Efavirenz The Steral Study
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STERAL
Brief 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 HIVHCV-coinfected patient
Secondary Trial Objective
1 To compare the proportion of HIVHCV-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 copiesmL 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
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 HIVHCV-coinfected patient
Secondary Trial Objective
1 To compare the proportion of HIVHCV-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 copiesmL 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 HIVHCV-coinfected patient
Secondary Trial Objective
1 To compare the proportion of HIVHCV-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 copiesmL 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
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 HIVHCV-coinfected patient
Secondary Trial Objective
1 To compare the proportion of HIVHCV-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 copiesmL 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None