Strategy for Maintenance of HIV suppression with once daily integrase inhibitor +darunavir/ritonavir in children

Can children remain healthy with a new combination of anti-HIV medicines compared with current standard HIV treatment?

What is this study about?

SMILE is a study that will compare two different combinations of HIV medicine.

Taking HIV medicines every day without missing a doses important. This is to stop the virus becoming resistant which can happen if the virus levels in the blood are not kept low. However, some young people experience difficulty in taking several medications every day, particularly if this is more than once a day, and so it is important to find easier ways for children and yound people to take the medicines. There are several different classes of HIV medicines. The older classes may be associated with side effects. it is increasingly important to investigate ways of reducing the possibility of side effects from long term HIV medication.

Newer HIV medicines which can be taken once daily include Prezista® (also called darunavir) which is taken with a small dose of Norvir® (ritonavir) and Tivicay® (dolutegravir). These medicines have been shown to be effective and safe, with few side effects, in adults and children.

Using these newer classes of medication may reduce the possibility of side effects which can be caused by long-term use of a particular class of medicine ("nucleoside reverse transcriptase inhibitors" or NRTIs). Some of the older NRTIs are associated with possible long term symptoms, such as fat loss in the face and limbs.

The SMILE study will check if a combination of medicines that does not include an NRTI is as effective and safe for young people as the current standard HIV treatment.

Type of study

Randomised trial

Contact details

Who is funding the study?

The study is receiving funding from Janssen and the PENTA foundation.

When is it taking place?

2016 – 2020

Where is it taking place?

The trial is taking place in hospital clinics in Western and Eastern Europe, South Africa, Thailand, Uganda and Latin America.

Who is included?

300 HIV infected children aged between 12 and 18 years who are currently receiving standard HIV treatment and have a very low (undetectable) level of virus in their blood.