Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00117494
Status:
COMPLETED
Last Update Posted:
2011-12-22
First Post:
2005-06-30
Brief Title:
Rosuvastatin Versus Pravastatin in HIV Patients Treated With Boosted Protease Inhibitors PI ANRS126
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Randomised Comparative Study of the Efficacy and Safety of Rosuvastatin and Pravastatin in Dyslipidemic Patients Treated With Antiretroviral Agents Anrs 126
Status:
COMPLETED
Status Verified Date:
2011-12
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:
None
Brief Summary:
In HIV hypercholesterolemic patients treated with protease inhibitors some drugs of the statin group are used to control cholesterol level New and potentially more efficient statins may interfere with protease inhibitors and hence loose a part of their activity They have thus to be compared with a more established drug of the same class eg pravastatin The protocol compares the efficacy and safety of rosuvastatin and pravastatin
Detailed Description:
The study compares the efficacy and safety of rosuvastatin and pravastatin among dyslipidemic HIV-seropositive patients treated with antiretroviral agents including a boosted protease inhibitor
It is an open multicenter randomised trial with two parallel groups comparing rosuvastatin with pravastatin
Statins are administered from D0 with a single daily dose in the morning for 45 consecutive days
The duration of the study for each patient will be 45 days not including the preselection period maximum 15 days
The primary end-point compares the change in LDL cholesterol between D0 and D45 in patients receiving rosuvastatin 10 mgday or pravastatin 40 mgday and treated by antiretroviral agents including a boosted Protease Inhibitor
Secondary end-points compares changes in triglycerides and HDL cholesterol percentage of patients with a normal value of LDL cholesterol HDL cholesterol and triglycerides on D45 clinical safety and laboratory safety parameters of rosuvastatin and pravastatin distribution profile of the diameter of LDL cholesterol particles
Cmin of rosuvastatin pravastatin and protease inhibitors PI are controlled at D15 for statins and PI
It is an open multicenter randomised trial with two parallel groups comparing rosuvastatin with pravastatin
Statins are administered from D0 with a single daily dose in the morning for 45 consecutive days
The duration of the study for each patient will be 45 days not including the preselection period maximum 15 days
The primary end-point compares the change in LDL cholesterol between D0 and D45 in patients receiving rosuvastatin 10 mgday or pravastatin 40 mgday and treated by antiretroviral agents including a boosted Protease Inhibitor
Secondary end-points compares changes in triglycerides and HDL cholesterol percentage of patients with a normal value of LDL cholesterol HDL cholesterol and triglycerides on D45 clinical safety and laboratory safety parameters of rosuvastatin and pravastatin distribution profile of the diameter of LDL cholesterol particles
Cmin of rosuvastatin pravastatin and protease inhibitors PI are controlled at D15 for statins and PI
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ANRS 126 | None | None | None |