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Cardiovascular Risk Factor Management in HIV Infection

NCT00264394 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4097

Last updated 2015-05-28

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Updated CHD risk profiles

Provision of computer generated CHD risk profiles

BEHAVIORAL

Guidelines

provision of guidelines for CHD risk factor management only

Sponsors & Collaborators

  • Swiss National Science Foundation

    collaborator OTHER

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Heiner C Bucher, MD · Basel Institute for Clinical Epidemiology University Hospital Basel

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2008-10-31
Completion
2010-02-28

Countries

  • Switzerland

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00264394 on ClinicalTrials.gov