Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147797
Status:
COMPLETED
Last Update Posted:
2016-10-25
First Post:
2005-09-02
Brief Title:
Influence of Pravastatin on Carotid Artery Structure and Function in HIV-infected Patients Under Antiretroviral Therapy
Sponsor:
Saint Antoine University Hospital
Organization:
Saint Antoine University Hospital
Study Overview
Official Title:
Influence of Pravastatin on Carotid Artery Structure and Function in HIV-infected Patients Under Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2007-04
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:
The advent of new antiretroviral agents in particular Highly Active Antiretroviral Therapy HAART spectacularly reduced HIV-associated morbidity and mortality However new complications have appeared in HIV-infected patients treated by with HAART such as dyslipidemia insulin resistance diabetes mellitus and related cardiovascular complications including acute coronary syndromes peripheral vascular disease and stroke have been reported
A linear association has been proved between increased intima-media thickness of the common carotid artery CCA-IMT aortic stiffness pulse wave velocity aPWV and incidence of cardiovascular events suggesting that IMT and aPWV could be considered as an early marker of atherosclerosis The progression of IMT has been shown to be predictive of cardiovascular events Case control and longitudinal studies but not all have suggested an increase CCA-IMT in HIV-infected patients under HAART compared with non-HIV infected patients with different progression
The aim of this study was to examine the effects of pravastatin on CCA-IMT and aortic stiffness in dyslipidemic HIV-infected patients receiving HAART by using a high-resolution echotracking system
Patients in the pravastatin group were consecutively recruited in four department of infectious diseases if they fulfilled the following criteria 1 HIV-infected treated with HAART for 12 months 2 with dyslipidemia defined as fasting serum LDL cholesterol 160 mgdL before initiation of pravastatin 3 treated with pravastatin 12 months and one more coronary risk factor The patients in the control group were selected consecutively in the same departments among 1 HIV-infected patients treated with HAART 12 months 2 fasting serum LDL cholesterol 160 mgdL 3 without lipid-lowering drugs and one more coronary risk factor Cases and control patients were matched for age gender and tobacco consumption
Using data from Mercie et al inclusion of 42 patients in pravastatin and control groups was the minimum sample size needed for detection of a 65 difference in CCA-IMT in a two-sided test a 005 b 020
The protocol of the study sponsored by the French Society of Cardiology was approved by the Committee for the Protection of Human Subjects in Biomedical Research of Pitié-Salpétrière University hospital in Paris Written informed consent to participate in the study was obtained from each patient
A linear association has been proved between increased intima-media thickness of the common carotid artery CCA-IMT aortic stiffness pulse wave velocity aPWV and incidence of cardiovascular events suggesting that IMT and aPWV could be considered as an early marker of atherosclerosis The progression of IMT has been shown to be predictive of cardiovascular events Case control and longitudinal studies but not all have suggested an increase CCA-IMT in HIV-infected patients under HAART compared with non-HIV infected patients with different progression
The aim of this study was to examine the effects of pravastatin on CCA-IMT and aortic stiffness in dyslipidemic HIV-infected patients receiving HAART by using a high-resolution echotracking system
Patients in the pravastatin group were consecutively recruited in four department of infectious diseases if they fulfilled the following criteria 1 HIV-infected treated with HAART for 12 months 2 with dyslipidemia defined as fasting serum LDL cholesterol 160 mgdL before initiation of pravastatin 3 treated with pravastatin 12 months and one more coronary risk factor The patients in the control group were selected consecutively in the same departments among 1 HIV-infected patients treated with HAART 12 months 2 fasting serum LDL cholesterol 160 mgdL 3 without lipid-lowering drugs and one more coronary risk factor Cases and control patients were matched for age gender and tobacco consumption
Using data from Mercie et al inclusion of 42 patients in pravastatin and control groups was the minimum sample size needed for detection of a 65 difference in CCA-IMT in a two-sided test a 005 b 020
The protocol of the study sponsored by the French Society of Cardiology was approved by the Committee for the Protection of Human Subjects in Biomedical Research of Pitié-Salpétrière University hospital in Paris Written informed consent to participate in the study was obtained from each patient
Detailed Description:
None
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 |
|---|---|---|---|
| 53-03 | None | None | None |