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
2 other identifiers
interventional
4,097
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2006
Longer than P75 for phase_4
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2005
CompletedFirst Posted
Study publicly available on registry
December 12, 2005
CompletedStudy Start
First participant enrolled
July 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedMay 28, 2015
May 1, 2015
2.3 years
December 9, 2005
May 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in total cholesterol in the entire SHCS population
18 months
Secondary Outcomes (1)
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
Study Arms (2)
Updated CHD risk profiles
EXPERIMENTALProvision of regularly updated CHD risk profiles
Guidelines
ACTIVE COMPARATORPhysicians received guidelines only
Interventions
Provision of computer generated CHD risk profiles
provision of guidelines for CHD risk factor management only
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Pregnant females
- Patients in the SHCS not receiving ART
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Basel, Switzerlandlead
- Swiss National Science Foundationcollaborator
- Bristol-Myers Squibbcollaborator
Study Sites (7)
University Hospital Basel
Basel, Canton of Basel-City, CH-4031, Switzerland
Division des Maladies Infectieuses, Hopital Universitaire Geneve
Geneva, Canton of Geneva, CH-1211, Switzerland
Division Maladies Infectieuses, Hopital Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, CH-1011, Switzerland
Departement Innere Medizin Kantonsspital St. Gallen
Sankt Gallen, Canton Saint Gall, CH-9007, Switzerland
Ospedale Civico Lugano
Lugano, Canton Ticino, CH-6903, Switzerland
Abteilung für Infektionskrankheiten & Spitalhygiene, Universitätsspital Zürich
Zurich, Canton Zurich, CH-8091, Switzerland
Klinik und Poliklinik für Infektiologie, Inselspital
Bern, CH-3010, Switzerland
Related 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.
PMID: 20167989BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heiner C Bucher, MD
Basel Institute for Clinical Epidemiology University Hospital Basel
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2005
First Posted
December 12, 2005
Study Start
July 1, 2006
Primary Completion
October 1, 2008
Study Completion
February 1, 2010
Last Updated
May 28, 2015
Record last verified: 2015-05