The Data Collection on Adverse events of Anti-HIV Drugs (D:A:D) is a prospective multi-cohort study of HIV-1 positive persons under active follow up. The purpose of the study is to assess the incidence of myocardial infarction among HIV/AIDS patients who are receiving anti-retroviral therapy.
11 cohorts worldwide are participating, with a total current enrolment of more than 49,000 patients from 212 clinics in 33 countries in Europe, USA and Australia. The patients have contributed 339,108 person-years of follow-up as of January 31st 2012. The original study population of 23,441 were enrolled December 1999 - April 2001, and is referred to as D:A:D Cohort I; an additional 12,900 were enrolled in D:A:D Cohort II throughout the Spring 2004, and more than 16,000 were enrolled in D:A:D Cohort III in 2010.
The data collection for D:A:D takes place at least every 8 months. Each cohort gathers and computerises its data which is subsequently merged in a database in Copenhagen. The core data in the study is information on incident cases of cardiovascular disease, which are reported immediately to the local cohort coordinating office by fax, using the event reporting forms.
The data collection also includes information on risk factors for cardiovascular disease, such as previous myocardial infarction or stroke, hereditary tendency, smoking status, diabetes mellitus, dyslipidemia and hypertension, non-AIDS defining malignancies, end-stage renal disease, end-stage liver disease and death.
Support for the study is given by 'The Oversight Committee for The Evaluation of Metabolic Complications of HAART', and a number of pharmaceutical companies producing anti-retroviral drugs contribute financially.
The study is supervised by a Steering Committee with representation from each cohort, EMA, patient community, and industry.