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Newsletter October 2001

Dear colleagues,

Thank you for your continuous collaboration as investigators in the D:A:D study - 'Data collection o­n Adverse Events of Anti HIV drugs'. We would like to give an update of the current status of the study:

The study has included more than 20.000 patients from the 11 participating cohorts. Baseline data o­n these patients were analysed with particular focus o­n cardiovascular risk factors, and abstracts assessing associations of antiretroviral therapy with cardiovascular risk factors has been accepted for presentation at several international conferences, including ICAAC (Chicago, December 2001), the 8th European Conference o­n Clinical Aspects and Treatment of HIV-infection (Athens, October 2001) and the Australian ASHM Conference (Melbourne, October 2001).

A manuscript is currently being developed, which describes the structure of the study and the baseline findings. The manuscript will be disseminated to the clinics upon acceptance for publication.

Thanks to the united efforts of all participants, follow-up data are becoming available, which includes information o­n the occurrence of myocardial infarction, stroke, invasive cardiovascular procedures, diabetes and 'fatal cases with insufficient data'. This will allow the study to address the central issue, whether HAART is associated with an increased risk of cardiovascular disease.

It remains paramount that all incident cases of the study endpoints are reported. For details regarding the diagnostic criteria, please refer to the D:A:D study's Manual of Operations (MOOP). The MOOP as well as all event reporting forms are electronically available at: http:// www.cphiv.dk. If you have any questions or doubts concerning completion of the forms, please contact the local study co-ordinator or Nina Friis-Møller (mailto://nfm@cphiv.dk) at the D:A:D co-ordinating centre.

One additional issue has emerged during the assessment of baseline data, namely the differences in assays used for analyses of lipid levels. We are kindly requesting that you correspond with your local cohort co-ordinator, providing details o­n assays used in your local laboratory for analyses of cholesterol (total and HDL) and triglycerides. The information we are requesting are product name of the assays used and applied reference intervals. Please complete the information o­n the included page and return it by fax no later than February 1st 2002.

We thank you for your attention to this notice and your continued collaboration.

Best regards, the D:A:D coordinating centre

Nina Friis-Møller, MD  Philip Ricks, MPH 
Study coordinator  Study datamanager 
 
Jens D. Lundgren, MD DMSC
Principal investigator

Updated: 03 Jan 2006