HIV i-Base

Article on START study in BASELINE magazine – June 2010

The START study ­– if your CD4 is over 500 off-treatment…

Simon Collins, HIV i-Base

An important new study is enrolling in the UK and needs your help. The START study (Strategic Timing of AntiRetroviral Therapy) looks at when to start treatment and many other aspects of HIV.

What is the study for?

The START study will randomise people to start HIV treatment when their CD4 count is above 500 or to wait until it reaches 350.

It is to look at the risks and benefits of earlier compared to later treatment.

Why is START so important?

Because no other study has done this.

Starting earlier may help your long-term health. We do not know whether this is at 350, 500, 700, 900 or just when you are diagnosed. This study will tell us this.

Which treatment can I use?

The choice of meds is entirely up to you and your doctor. Because all drugs are provided free in the study, when you come to start treatment, you may have the options to choose newer meds that are not routinely available.

What are the benefits for me?

  • The first benefit is that you will be contributing to research that will expand our knowledge about HIV.
  • If you join one of the sub-studies, you may be monitored with tests that are not currently part of routine care, including looking at brain functioning, bone health and heart and lung health.
  • Monitoring and care in a study are usually more intensive that in the general clinic. You will have the chance to speak to doctors or nurses more, if you need this.
  • You could get earlier treatment if you are randomised to this group.
  • Whether you start treatment immediately or when you CD4 count reaches 350, you may have a wider choice of drugs to choose from.

Why else would I want to start treatment so early?

The main reason is the believed benefit this could have on your long-term health.

Your CD4 count will stay higher – because this is always related to how high it is when you start.

This may only mean starting a year or two earlier than waiting until 350.

Other benefits include reducing your risk of transmitting HIV because an undetectable viral load makes you less infectious.

What are the benefits if I am in the deferred group?

Deferring treatment will give you a year or two longer before you have to get your head around treatment and the importance of adherence.

You will have more time to prepare for treatment, although this may only be a year or two difference for many people.

You may also have the choice of newer medications when you come to start treatment, and may benefit from more recent research about the best drugs to start with.

Starting at 350 is the current standard of care in the UK and most European countries. If you need to start treatment earlier for any medical reason, this is of course allowed.

Which is the ‘best’ group to get in?

This is the crucial question. It is why we need the study.

Some experts might think one thing and others another. There is a lot of discussion and opinions but little solid evidence.  Nearly all experts agree on one thing – that is that we don’t have enough evidence either way.

This will only come from a large randomised trial – and START is enrolling 4000 people in 30 countries.

When will the results be known?

The study is planned to run for five years. It is thought to need this time because the differences between the two groups may only be small.

However, a similar sized study, also planned to last over five years, in fact answered the study question much earlier – within two years.

If the results are seen sooner, the study might be shorter.

Where are the study sites?

Your have to visit one of the sites in London, Brighton or Leicester. Travel costs can be reimbursed for this if you decide you want to take part.

Many more clinics across the country will join next year, but getting this first phase enrolled is critical for making sure the study continues.

Further information

For further information, talk to a doctor or nurse at your clinic, or, in confidence, email:

START@ctu.mrc.ac.uk

If you would like to talk about START or any other treatment issue with an independent community treatment advocate, call the i-Base phoneline:

0808 800 6013

Mon, Tues, Wed: 12.00–4.00pm