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

December 9, 2005
June 25, 2012
July 2006
October 2008   (final data collection date for primary outcome measure)
Reduction in total cholesterol in the entire SHCS population [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Reduction in total cholesterol in the entire SHCS population
Complete list of historical versions of study NCT00264394 on ClinicalTrials.gov Archive Site
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 ]
the reduction in total cholesterol, systolic and diastolic blood pressure, and Framingham 10-year CHD risk score in individiuals with a greater equal 105 10 year risk of CHD (according to the Framingham risk profile)
Not Provided
Not Provided
 
Cardiovascular Risk Factor Management in HIV Infection
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Coronary Heart Disease
  • Dyslipidemia
  • Diabetes Mellitus, Non-Insulin-Dependent
  • HIV Infection
  • Behavioral: Updated CHD risk profiles
    Provision of computer generated CHD risk profiles
    Other Name: Computer assisted intervention to reduce CHD risk
  • Behavioral: No Intervention: Guidelines
    provision of guidelines for CHD risk factor management only
    Other Name: guidelines group
  • Experimental: Updated CHD risk profiles
    Provision of regularly updated CHD risk profiles
    Intervention: Behavioral: Updated CHD risk profiles
  • No Intervention: Guidelines
    Physicians received guidelines only
    Intervention: Behavioral: No Intervention: Guidelines
Bucher HC, Rickenbach M, Young J, Glass TR, Vallet Y, Bernasconi E, Cavassini M, Fux C, Schiffer V, Vernazza P, Weber R, Battegay M; Swiss HIV Cohort Study. Randomized trial of a computerized coronary heart disease risk assessment tool in HIV-infected patients receiving combination antiretroviral therapy. Antivir Ther. 2010;15(1):31-40. doi: 10.3851/IMP1475.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4097
February 2010
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00264394
SNF 3345-062041 SHCS 480, 480, 480
Yes
Heiner C. Bucher, University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
  • Swiss National Science Foundation
  • Bristol-Myers Squibb
Principal Investigator: Heiner C Bucher, MD Basel Institute for Clinical Epidemiology University Hospital Basel
University Hospital, Basel, Switzerland
June 2012

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