DSMB open report strongly supports importance of START study

The ninth open report from the independent Data and Safety Monitoring Board (DSMB) for the international randomised START study is available online and “enthusiastically endorses continuation, of this pivotal randomised trial that will provide the highest level of evidence about when to start ART”.

The START study 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.

START enrolled the first patient 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.