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
  Purpose

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.


Condition
HIV Infection
Carotid Atherosclerosis
Dyslipidemia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Influence of Pravastatin on Carotid Artery Structure and Function in HIV-Infected Patients Under Antiretroviral Therapy

Resource links provided by NLM:


Further study details as provided by Saint Antoine University Hospital:

Estimated Enrollment: 84
Study Start Date: May 2003
Estimated Study Completion Date: June 2005
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147797

Locations
France
Department of Pharmacology and INSERM U652, Hôpital Européen Georges Pompidou
Paris, France, 75015
Sponsors and Collaborators
Saint Antoine University Hospital
French Cardiology Society
Investigators
Study Director: Stephane Laurent, MD, PhD Department of Pharmacology and INSERM U652, Hôpital Européen Georges Pompidou, Paris, France
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00147797     History of Changes
Other Study ID Numbers: 2003-01, 53-03
Study First Received: September 2, 2005
Last Updated: April 18, 2007
Health Authority: France: Ministry of Health

Keywords provided by Saint Antoine University Hospital:
Atherosclerosis
intima media thickness
aortic stiffness
HIV infection
Dyslipidemia
Treatment Experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Arteriosclerosis
Atherosclerosis
Carotid Artery Diseases
Dyslipidemias
HIV Infections
Infection
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Lipid Metabolism Disorders
Metabolic Diseases
Nervous System Diseases
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Vascular Diseases
Virus Diseases
Pravastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors

ClinicalTrials.gov processed this record on October 22, 2014