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START study: enrolling well, open DSMB report shows no concerns

In Washington, prior to the World AIDS Conference, the INSIGHT research group is holding several meetings relating to the START study. Of these, I  am attending the Community Advisory Board today and the Scientific Steering Committee tomorrow.

Also tomorrow, there is an investigators meeting for the START study and a satellite meeting reviewing the SMART study that was run by the same research team.

The START study is likely to be the most important HIV study for the next five years.

It is enrolling about 4000 people with high CD4 counts (over 500). Half will start treatment straight away and half will wait until their CD4 count reaches 350.

As well as looking at advantages and disadvantages of starting treatment earlier, there are many sub-studies. These will answer important aspects about HIV – for example, relating to brain function or bone health – and whether earlier treatment helps.

Over two-thirds of people are now enrolled.

An open report covering enrolment results is available from the study website. This shows that most people are relatively recently diagnosed. Although everyone needs a CD4 count higher than 500, many people are much higher than this – 25% have CD4 counts over 800.

This shows that even at high CD4 counts, people are interested enough in the potential benefits of early treatment to enter the study. It also shows that the evidence supporting the safety of waiting until later is still strong. The report shows that people are happy to stay in the group that they are randomised to.

In 50% of people who have had a resistance test, 11% had resistance to at least one class of HIV drugs – half of these involve NNRTI resistance. And 1.1% have resistance to two or more drug classes.

Viral load is generally low. For 40% of people this is less than 10,000 copies/mL but approximately 10% had viral load levels higher than 100,000 when they joined the study.

If your CD4 count is currently higher than 500 and you have never taken treatment, this is a good study to join. As well as taking part in important research you may get the option to use HIV drugs that might not otherwise be available in your country.

For example, if you life in London, you could start with the integrate inhibitor called raltegravir, that is otherwise too expensive to be a first-line choice.

Website page for DSMB reports.

DSMB report (May 2012)

Homepage for START study.

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