Cardiovascular Risk Factor Management in HIV Infection

HIV Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264394
• Other study ID #: SNF 3345-062041 SHCS 480
• Secondary ID: 480480
• Status: Completed
• Phase: Phase 4
• First received: December 9, 2005
• Last updated: May 27, 2015
• Start date: July 2006
• Est. completion date: February 2010

Study information

• Verified date: May 2015
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Laws and standards
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4097
• Est. completion date: February 2010
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Diabetes Mellitus, Non-Insulin-Dependent
• Diabetes Mellitus, Type 2
• Dyslipidemia
• Dyslipidemias
• HIV Infection
• HIV Infections
• Infection
• Myocardial Ischemia

Intervention

Behavioral:
• Updated CHD risk profiles
Provision of computer generated CHD risk profiles
• Guidelines
provision of guidelines for CHD risk factor management only

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	Kanton Basel Stadt
Switzerland	Klinik und Poliklinik für Infektiologie, Inselspital	Berne
Switzerland	Division des Maladies Infectieuses, Hopital Universitaire Geneve	Geneva
Switzerland	Division Maladies Infectieuses, Hopital Universitaire Vaudois (CHUV)	Lausanne	Vaud
Switzerland	Ospedale Civico Lugano	Lugano	Canton Ticino
Switzerland	Departement Innere Medizin Kantonsspital St. Gallen	St. Gallen	Canton St. Gall
Switzerland	Abteilung für Infektionskrankheiten & Spitalhygiene, Universitätsspital Zürich	Zurich	Canton Zurich

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Bristol-Myers Squibb, Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in total cholesterol in the entire SHCS population		18 months	No
Secondary	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)		18 months	No

External Links

•   Basel Institute for Clinical Epidemiology & Biostatistics
•   Swiss HIV Cohort Study