Influence of Pravastatin on Carotid Artery Structure and Function in HIV-Infected Patients Under Antiretroviral Therapy

This study has been completed.
Sponsor:
Collaborator:
French Cardiology Society
Information provided by:
Saint Antoine University Hospital
ClinicalTrials.gov Identifier:
NCT00147797
First received: September 2, 2005
Last updated: April 18, 2007
Last verified: April 2007

September 2, 2005
April 18, 2007
May 2003
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Complete list of historical versions of study NCT00147797 on ClinicalTrials.gov Archive Site
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Influence of Pravastatin on Carotid Artery Structure and Function in HIV-Infected Patients Under Antiretroviral Therapy
Influence of Pravastatin on Carotid Artery Structure and Function in HIV-Infected Patients Under Antiretroviral Therapy

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 mg/dL 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 mg/dL 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 6.5% difference in CCA-IMT, in a two-sided test (a = 0.05, b = 0.20).

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.

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Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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  • HIV Infection
  • Carotid Atherosclerosis
  • Dyslipidemia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
June 2005
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Inclusion Criteria:

  • HIV-infected patients treated with HAART for > 12 months
  • With dyslipidemia, defined as LDL cholesterol > 160 mg/dL before initiation of statin
  • 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

    • HIV-infected patients treated with HAART > 12 months
    • LDL cholesterol > 160 mg/dL
    • Without lipid-lowering drugs and one more coronary risk factor. Cases and control patients were matched for age, gender and tobacco consumption.

Exclusion Criteria:

  • Patients with history of coronary artery disease, peripheral artery disease, endarterectomy, aortic dissection
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00147797
2003-01, 53-03
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Saint Antoine University Hospital
French Cardiology Society
Study Director: Stephane Laurent, MD, PhD Department of Pharmacology and INSERM U652, Hôpital Européen Georges Pompidou, Paris, France
Saint Antoine University Hospital
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP