Cardiovascular Risk Factor Management in HIV Infection

This study has been completed.
Sponsor:
Collaborators:
Swiss National Science Foundation
Bristol-Myers Squibb
Information provided by (Responsible Party):
Heiner C. Bucher, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00264394
First received: December 9, 2005
Last updated: June 25, 2012
Last verified: June 2012
  Purpose

There is growing evidence that antiretroviral therapy (ART) increases the risk of coronary heart disease (CHD) through metabolic side effects, such as dyslipidemia, insulin resistance, and type II diabetes. Prevalence of risk factors for CHD in HIV-infected individuals receiving ART in the Swiss HIV Cohort Study (SHCS) is high. This cluster randomised controlled trial is nested into the SHCS and will investigate whether physicians randomised to the routine provision of risk profiles from their patients receiving ART will improve the management of risk factors in HIV-infected patients compared to control physicians not routinely receiving such information. Risk profiles will be generated by the SHCS data center and provided to clinicians in all study centers.


Condition Intervention Phase
Coronary Heart Disease
Dyslipidemia
Diabetes Mellitus, Non-Insulin-Dependent
HIV Infection
Behavioral: Updated CHD risk profiles
Behavioral: No Intervention: Guidelines
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy of a Computerised Physician Reminder System to Control Cardiovascular Risk Factors in HIV-infected Patients Receiving Antiretroviral Therapy: A Nested Randomised Controlled Cluster Trial Within the Swiss HIV Cohort Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Reduction in total cholesterol in the entire SHCS population [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The reduction in total cholesterol, systolic and diastolic blood pressure, and Framingham 10-year CHD risk score in individuals with a greater than or equal to 10% 10 year risk of CHD (according to the Framingham risk profile) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 4097
Study Start Date: July 2006
Study Completion Date: February 2010
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Updated CHD risk profiles
Provision of regularly updated CHD risk profiles
Behavioral: Updated CHD risk profiles
Provision of computer generated CHD risk profiles
Other Name: Computer assisted intervention to reduce CHD risk
No Intervention: Guidelines
Physicians received guidelines only
Behavioral: No Intervention: Guidelines
provision of guidelines for CHD risk factor management only
Other Name: guidelines group

Detailed Description:

Evidence from the D.A.D. study, an international cohort study which includes a large proportion of SHCS patients, suggests that exposure to antiretroviral therapy (ART) increases the risk of coronary heart disease (CHD) most likely due to ART induced metabolic changes like dyslipidemia, insulin resistance, and type II diabetes. The exact mechanisms for these metabolic changes and whether specific classes or combinations of ART are causally related to these changes are not known. Of males aged < 40 and > 40 years in the SHCS, 8.8% and 32.5% are at moderate (10% - 20%) and 1.7% and 6.9% at high (≥ 20%) risk of CHD in 10 years according to the Framingham algorithm. The overall percentage at moderate and high 10-year risk of CHD was 14.9% and 3.0%, respectively. Therefore, an intervention to reduce CHD risk among individuals at high risk for CHD is warranted. We propose a randomised controlled cluster intervention trial to reduce total cholesterol in all HIV-infected individuals in the SHCS (primary endpoint) and in those with greater than or equal to 10% 10 year risk of CHD based on the Framingham score (secondary endpoint). The intervention is the receipt of structured continuously updated information on CHD risk factors and treatment of CHD risk factors of HIV-infected patients. Randomisation will be done at the physician level and stratified by centre (7 centres of the SHCS, outpatient clinic or hospital), and size of patient volume for registered private practices. For physicians randomised to the intervention group, a flow sheet with information on risk factors and treatment status of CHD will be provided for each of their patients every 6 months by the SHCS data centre. Each centre and each physician treating SHCS patients will receive internationally and locally approved guidelines for the management of risk factors for CHD in HIV-infected patients. The intervention will be limited to 18 months. Our goal is a 7% reduction in total cholesterol (primary endpoint) between the intervention and the control group in the entire cohort. With alfa-error of 5%, power of 80% and a loss to follow-up of 10%, 408 patients per arm will be needed. Sample size calculations adapted to the cluster design of the trial show that we have sufficient power to detect a 12% reduction in total cholesterol in patients receiving ART and at moderate to high risk of CHD. Further secondary endpoints are a reduction of systolic and diastolic blood pressure and of overall Framingham risk score. We will additionally monitor whether changes in ART due to high risk of CHD, or treatment of CHD risk factors decreases the proportion of patients with non-sustained control of HIV-viremia. Data from this nested cluster trial will provide important information as to whether provision of an individual's CHD profile will improve monitoring and reduce CHD risk factors in HIV-infected patients in the SHCS.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For analysis of the primary endpoint:

  • All individuals in the SHCS

    • aged 18 or older
    • have a cohort visit in the 12 months preceding the randomisation date with a complete baseline dataset on CHD risk factors

For analysis of secondary endpoints:

  • All individuals in the SHCS

    • aged 18 or older
    • have a cohort visit in the 12 months preceding the randomisation date with a complete baseline dataset on CHD risk factors
    • at least 3 months of ART and at moderate to high risk of CHD (10% 10 years risk of CHD according to the Framingham risk score).

Exclusion Criteria:

  • Pregnant females
  • Patients in the SHCS not receiving ART
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264394

Locations
Switzerland
Departement Innere Medizin Kantonsspital St. Gallen
St. Gallen, Canton St. Gall, Switzerland, CH-9007
Ospedale Civico Lugano
Lugano, Canton Ticino, Switzerland, CH-6903
Abteilung für Infektionskrankheiten & Spitalhygiene, Universitätsspital Zürich
Zurich, Canton Zurich, Switzerland, CH-8091
University Hospital Basel
Basel, Kanton Basel Stadt, Switzerland, CH-4031
Division Maladies Infectieuses, Hopital Universitaire Vaudois (CHUV)
Lausanne, Vaud, Switzerland, CH-1011
Klinik und Poliklinik für Infektiologie, Inselspital
Berne, Switzerland, CH-3010
Division des Maladies Infectieuses, Hopital Universitaire Geneve
Geneva, Switzerland, CH-1211
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Bristol-Myers Squibb
Investigators
Principal Investigator: Heiner C Bucher, MD Basel Institute for Clinical Epidemiology University Hospital Basel
  More Information

Additional Information:
No publications provided by University Hospital, Basel, Switzerland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Heiner C. Bucher, Prof. Dr. med., University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00264394     History of Changes
Other Study ID Numbers: SNF 3345-062041 SHCS 480, 480, 480
Study First Received: December 9, 2005
Last Updated: June 25, 2012
Health Authority: Switzerland: Laws and standards

Keywords provided by University Hospital, Basel, Switzerland:
Computer generated reminder system
quality control
dyslipidemia
antiretroviral therapy
HIV infection

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Dyslipidemias
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on April 16, 2014