START trial if you were recently diagnosed

START newly diagnosed leaflet PDF (60 Kb)

The START study – if you have been recently diagnosed…

Do you have a CD4 count over 500?

  • Were you recently diagnosed?
  • Are you not yet on HIV treatment?

This leaflet explains why early treatment might be a good idea, even though UK guidelines say waiting until 350 is recommended for most people…

If you only recently found out that you are HIV-positive then this is still probably a difficult time. Most people find it takes time to accept and understand. Most people also find that it does get easier. Even if this feels like a slow process, one day you will find you hardly ever think about it.

You may already have discussed HIV treatment with your doctor. In the UK, the current guidelines are generally to wait until your CD4 count drops to 350. But when to start treatment has changed many times over the years and is likely to change again in the future.

A large study called START is now running in the UK to look at this.

UK guidelines and other guidelines: 350, 500 or higher

Although the current UK guidelines use a CD4 count of 350, some countries recommend earlier treatment at higher CD4 counts.

In the US, Australia and France, treatment is recommended for anyone with a CD4 count under 500. In the US, the guidelines also recommend treatment above 500, though it is not a strong recommendation because there is very little accurate research to base these decisions on.

The guidelines come to different conclusions partly because of the lack of evidence and partly because different doctors interpret the limited evidence differently. Most doctors recognise that above 350, the risks from not using treatment are low, but that there may be benefits. This is where START will help.

There are advantages and disadvantages for starting early and also for waiting until 350. Either option could turn out to be better or worse. This is the best time to run a study, because it means there is equipoise. This is the medical term for “no-one really knows either way”.

If you would be happy to either start treatment while your CD4 count is above 500 or to wait to 350, then joining the START study is a real way to help HIV research. Some of the advantages and disadvantages for joining each group are listed below. Because any difference may be small, the study may need to run for several years.

When you start treatment, the drugs you use will be for you and your doctor to choose, and you will get a wider choice than if you are not in the study. You may also have more frequent routine monitoring, and have the chance to have special tests if you join a substudy.

Starting above 500: pros and cons

The benefits of earlier treatment include:

  • Limiting the chance for HIV to damage your immune system.
  • Your CD4 count will stay higher.
  • An undetectable viral load reduces the risk to your sexual partners.
  • Your immune systems ‘rests’ rather than being active due to inflammation.
  • You may feel that you are actively treating HIV.
  • The study may find that earlier treatment benefits your health.

The disadvantages of earlier treatment include:

  • Having to learn about treatment and treatment choices earlier.
  • Taking medication each day (this can be as little as one pill a day).
  • Potential side effects, though these are usually mild and resolve.
  • The study may find that earlier treatment has no benefit.

Waiting until 350: pros and cons

The benefits of waiting until 350 include:

  • Having a longer period before you start medication may help you feel that HIV hasn’t changed your life.
  • If you are not taking drugs you cannot get side effects, where they are mild or more serious.
  • You do not have to worry about adherence each day (remembering to take your meds).
  • The study may find that earlier treatment has no benefit.

The disadvantages of waiting until 350 include:

  • A risk that HIV will damage your immune system.
  • The small increased risk of rare but serious health complications.
  • You will be more infectious to your sexual partners (for example if a condom breaks).
  • The study may find that earlier treatment has a benefit.

As you are recently diagnosed you will need to think about these options before deciding to join a study. You will get good care whether you join the study or not.

In the START study, you may get more frequent monitoring compared to routine clinic care, whether you are on treatment or not. You will also have the option to choose from a wider range of drugs when you do come to start.

You need be happy whichever group you join, and see the advantages of being in each group. This is because the group you join will be decided randomly – like tossing a coin. This will make the final results more accurate and reliable.

If you would like more information and think you may be interested in this study, please speak to your doctor or health worker. Or contact the i-Base phoneline on the number below.

HIV i-Base is a treatment advocacy project based in London that has run a treatment phoneline by HIV-positive people for over 10 years. Free publications include the HIV Treatment Bulletin and a range of non-technical treatment guides.

The i-Base Treatment Phoneline is an anonymous and confidential phoneline on any aspect of HIV treatment: 0808 600 6013:12.00–4.00pm on Mon, Tues and Weds.