General information
A total of 49,731 HIV-positive persons from more than 210 centres have contributed to the 339,108 person years of follow-up in the D:A:D study. Over the past 13 years 4,098 people have died, and the numbers of confirmed reports include 893 MIs, 575 strokes
and more than 1000 Non-AIDS-defining cancers.
Funding
The HAART Oversight Committee (OC) has agreed to support the D:A:D study until the completion of the 17th merger in 2016, and negotiations are underway to agree on the size of the budget. It is, however, already clear that the future budget will have to be
trimmed somewhat; over the next few months, the D:A:D Steering Committee (SC) will undertake negotiations with both the contributing cohorts and the OC to determine the support that will be available.
Event Case Report Forms (CRFs)
High quality reporting of relevant details relating to each event through completion of the standardized CRF is a critical component of the continued success of the D:A:D Study. Thanks to all colleagues who continue to contribute to this effort. Medical staff
at the CC review all forms received, and may ask sites for further clarification to ensure that we are able to classify the event appropriately according to our standard algorithms.
Most important recent changes to the CRFs and Manual of operations (MOOP)
Over the last year the D:A:D study MOOP and the CRFs have been revised and circulated for comments among SC members and data managers. The updated documents are circulated with the newsletter. These changes include:
- Renaming chronic liver disease (CLD) to end-stage liver disease (ESLD)
- Inclusion of HgbA1C as a criteria for diagnosis of diabetes
- Inclusion of all AIDS-defining-cancers into the prospective cancer reporting with a single CRF to report both AIDS- and Non-AIDS-defining cancers.
Please remember....
For the continued success of the study, it remains critical that all incident cases of study endpoints are reported in a timely and detailed manner. We encourage sites to continue to closely follow patients involved in D:A:D and to promptly report all relevant
events to the CC.
Please also remember that all D:A:D events described via a fatal case (CoDe) form must also be reported via a separate designated CRF for that event type.
Upcoming deadlines, event query and Merger 14
During Spring all cohorts will receive a list of pending events including:
- Events not yet reported
- Events with outstanding/incomplete source data
- Events with a date discrepancy
Please send all outstanding events to the D:A:D CC before 5 April, 2013
The data submission deadline for Merger 14 is 3 June, 2013
D:A:D SC Meeting
The next D:A:D SC face-to-face meeting will be held 5 March 2013 during CROI in Atlanta.
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RECENT PUBLICATIONS:
Link to publications
1. Antiretroviral drug-related liver mortality among HIV-positive persons in the absence of HBV or HCV co-infection. The Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Study.
H Kovari, C Sabin, B Ledergerber, L Ryom, SW Worm, C Smith, A Phillips, P Reiss, E Fontas, K Petoumenos, S De Wit, P Morlat, JD Lundgren, R Weber CID. 2012.Oct.20
2. Predicting the short term risk of diabetes in HIV positive patients: The Data Collection on Adverse events of Anti-HIV Drugs (D:A:D) Study.
K Petoumenos, SW Worm, E Fontas, R Weber, S De Wit, M Bruyand, P Reiss, W El-Sadr, AD Monforte, N Friis-Møller, JD Lundgren, MG Law On behalf of the D:A:D Study Group JIAS. 2012. Oct
3. Atazanavir (ATV)-Containing Antiretroviral Treatment is not Associated with an Increased Risk of Cardio- or Cerebro-Vascular Events (CVE) in the D:A:D Study.
AD Monforte, P Reiss, L Ryom, W El-Sadr, F Dabis, S De Wit, SW Worm, A Phillips, JD Lundgren, C Sabin. In press AIDS
4. Exposure to Antiretrovirals (ARVs) and the Risk of Renal Impairment among HIV+ Persons with Normal Baseline Renal Function: the D:A:D Study.
L Ryom, A Mocroft, SW Worm, DA Kamara, P Reiss, M Ross, C Fux, P Morlat, O Moranne, C Smith, O Kirk and JD Lundgren on behalf of the D:A:D study group. In press JID
RECENT PRESENTATIONS:
Link to presentations
CROI 2012 Seattle: Non-AIDS defining malignancies (NADMs) and immunosuppression: The D:A:D study.
S Worm et al. (Oral)
Associations between markers of immunosuppression and the risk of cardiovascular (CV) disease: The D:A:D study.
C Sabin et al. (Poster)
Atazanavir (ATV)- containing antiretroviral treatment is not associated with an increased risk of cardio- or cerebro-vascular events (CVE) in the D:A:D study.
A d’Arminio Monforte et al. (Poster)
Exposure to antiretrovirals (ARVs) and the risk of renal impairment among HIV+ persons with normal baseline renal function: the D:A:D study.
L Ryom et al. (Poster)
16th IWHOD Athens 2012: The importance of well validated outcomes when assessing the association between the latest CD4 count and the risk of stroke.
C. Sabin et al. (Oral)
Fasting and non-fasting cholesterol and risk of myocardial infarction (MI): The D:A:D study.
DA. Kamara et al. (Poster)
IAS 2012 Washington:
Trend s over time in underlying causes of death in the D:A:D Study from 1999 to 2011
CJ Smith et al. (Oral)
Glasgow 2012:
Impact of antiretroviral therapy (ART), immunosuppression and viraemia on lipid levels: the D:AD Study
DA Kamara et al. (Thistle Poster)
CROI 2013:
Four abstracts accepted for presentation
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