PENTA 11

Treatment interruption in children with chronic HIV-infection

Can children safely stop their anti-HIV medicines for periods of time?

What is this study about?

The aim of this trial was to compare two different ways of giving antiretrovirals (anti-HIV medicines) to children, either: 1. Taking the medicines all of the time (the current standard way of treating HIV),

or

2. Having breaks in treatment (stopping and re-starting the medicines depending on the child’s level of immunity).

The PENTA 11 - TICCH trial examined whether anti-HIV medicines can safely be stopped for periods of time in children.

Type of study

Randomised trial

Contact details

penta.mrcctu@ucl.ac.uk

Who is funding the study?

This trial was supported in the UK by the Medical Research Council. In Europe, the trial was funded by PENTA, an organisation funded mainly by the European Commission.

When is it taking place?

Recruitment to this trial was completed in December 2006. The randomised phase was completed in May 2008. All children have now been followed up for 5 years.

Results were presented at the HIV 9 conference in November 2008.

Where is it taking place?

The trial recruited children from France, Germany, Italy, Poland, Spain, Switzerland, Thailand, USA, and the UK.

Who is included?

Children who had HIV infection and are between the ages of 2 to 15 years. To be eligible to enter the trial, children must have: Been taking 3 antiretrovirals for 24 weeks or more; Had a high level of immunity to infections (measured by the CD4 or “fighter cells” count); An undetectable level of HIV virus in the blood.