Status:

COMPLETED

Cardiovascular Risk Factor Management in HIV Infection

Lead Sponsor:

University Hospital, Basel, Switzerland

Collaborating Sponsors:

Swiss National Science Foundation

Bristol-Myers Squibb

Conditions:

Coronary Heart Disease

Dyslipidemia

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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 dia...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • Pregnant females
  • Patients in the SHCS not receiving ART

Key Trial Info

Start Date :

July 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2010

Estimated Enrollment :

4097 Patients enrolled

Trial Details

Trial ID

NCT00264394

Start Date

July 1 2006

End Date

February 1 2010

Last Update

May 28 2015

Active Locations (7)

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Page 1 of 2 (7 locations)

1

University Hospital Basel

Basel, Canton of Basel-City, Switzerland, CH-4031

2

Division des Maladies Infectieuses, Hopital Universitaire Geneve

Geneva, Canton of Geneva, Switzerland, CH-1211

3

Division Maladies Infectieuses, Hopital Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland, CH-1011

4

Departement Innere Medizin Kantonsspital St. Gallen

Sankt Gallen, Canton Saint Gall, Switzerland, CH-9007