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Large scale research programme - The Data Collection on Adverse Events of...

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Title Large scale research programme - The Data Collection on Adverse Events of Anti_HIV Drugs (D:A:D)
Period 99 / 2005 - unknown
Status Completed
Research number OND1333044
Data Supplier Website Stichting HIV Monitoring

Abstract

The DAD cohort study is an observational cohort study collecting data of HIV-infected patients under active follow up in a large number of existing cohorts, including ATHENA. The main purpose of the study is to evaluate the long-term cardiovascular side effects of antiretroviral therapy by assessing the incidence of myocardial infarction (MI) and other atherosclerosis-related evnts among HIV/AIDS patients, and to relate this to exposure to combination antiretroviral therapy (cART) and the prevalence of known cardiovascular risk factors. The original primary analysis of the study has indeed demonstrated an increased risk of MI in relation to more prolonged exposure to cART, independent of other known CVD risk factors such as age, smoking, hypertension, gender etc. Extending the follow up is crucial to study how the demonstrated increased risk will evolve over time, and hopefully will also allow to study whether there are differences in risk between different cART regimens. 11 cohorts across the world are participating and the study has enrolled more than 23.000 patients (including 2861 ATHENA patients) in Cohort I from December 1999 to April 2001. An additional 12000 patients were enrolled in Cohort II from May 2001 to February 2004. 5566 ATHENA/HMF patients will be enrolled in Cohort II during 2005. The study period has been extended and is projected to last at least until 2006 and possibly longer.

Abstract (NL)

De DAD cohort studie is een observationele cohort studie, waarbij data worden verzameld van HIV geïnfecteerden bij een groot aantal bestaande cohorten, waaronder ATHENA. De primaire analyse van de DAD studie heeft inderdaad een verhoogd risico op het krijgen van een hartinfarct aangetoond in relatie tot de duur van gebruik van combinatietherapie voor HIV, onafhankelijk van bekende cardiovasculaire risicofactoren als roken, geslacht, hypertensie, leeftijd e.d. Verdere follow up en uitbreiding van het cohort is essentieel teneinde te bestuderen hoe dit verhoogde risico zich zal ontwikkelen naar de toekomst toe, en zal hopelijk ook enig inzicht verschaffen in hoeverre er verschillen bestaan tussen verschillende soorten combinatieregimes.

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Project leader Prof.dr. P. Reiss

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