START study open DSMB report (May 2014)
17 June 2014. Related: Research studies.
The latest open report from the Data and Safety Monitoring Board (DSMB) for the international randomised START study is now online.
START looks at the risks and benefits of immediate treatment (at any CD4 count above 500 cells/mm3) compared to waiting until the CD4 count reaches around 350 cells/mm3.
The study first opened in December 2009 and is now fully enrolled with 4685 participants.
This 58-page report is an important summary of the baseline characteristics in the study, including for the important sub-studies. It also includes a review of ongoing retainment and details of individual reasons for study withdrawal and loss to follow-up.
The study is driven by serious clinical events, with the primary endpoint being the time to a serious AIDS event or death from any cause. Follow-up will continue until there have been 213 events, which is estimated to be at the end of 2016.
The DSMB strongly supports the safety of continuing the study and affirms the importance of obtaining randomised data to inform this essential study question on the timing of ART.
DSMB reports from START
Direct link to PDF file of May 2014 report:
The INSIGHT website is not so intuitive to use until you get used to the navigation.
This is the main home page for the INSIGHT network:
From the left hand menu, click “HIV studies” to get:
Then click ‘START’ from the left hand menu, getting to:
Then click “Safety” from the sub menus for the study (still on the left), getting to:
Then click “DSMB — Data and Safety Monitoring Board Reports” from the main page, getting to:
This page includes alll the DSMB reports since 2009 – and is pretty amazing in terms of transparency for an ongoing study – if only it was a little easier to find.