PENTA 11
Treatment interruption in children with chronic HIV-infection
Can children safely stop their anti-HIV medicines for periods of time?
What was this study about?
The PENTA 11 - TICCH trial examined whether anti-HIV medicines can safely be stopped for periods of time in children.
The aim of this trial was to compare two different ways of giving antiretrovirals (anti-HIV medicines) to children, either:
- Taking the medicines all of the time (the current standard way of treating HIV),
Or
- Having breaks in treatment (stopping and re-starting the medicines depending on the child’s level of immunity). Children in this group stopped treatment for up to 48 weeks, restarting treatment earlier if their immune system was compromised (measured by CD4% (a marker in the blood)) or they became ill. After 24 weeks back on continuous treatment, children whose CD4% had recovered were eligible for a second treatment interruption.
109 children were in the trial (53 on continuous treatment and 56 who had treatment interruptions). The primary outcome was a combined outcome of low CD4% or a serious clinical event or death. During the trial one child in the continuous treatment group and four children in the treatment interruption group had reached a low CD4% outcome. No child died or had a new serious clinical event.
At the end of the trial children in the treatment interruption group returned to continuous treatment and all children were followed-up. After two years further follow-up children in the two groups had similar clinical, immunological and virological outcomes. Five year data are now being analysed.
What difference did this study make?
Interruption of anti-HIV medicines is not recommended. However, this study showed that children who interrupt treatment may be at less risk of serious long-term harm than adults (where treatment interruptions have been associated with higher risks of death and clinical events).
Type of study
Randomised trial
Contact details
Who funded 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 did it take place?
Recruitment to this trial was completed in December 2006. The randomised phase was completed in May 2008. All children were then followed up for a further 5 years.
Results were presented at the HIV 9 conference in November 2008.
Where did it take place?
The trial recruited children from France, Germany, Italy, Poland, Spain, Switzerland, Thailand, USA, and the UK.
Who was included?
Children who had HIV infection and were between the ages of 2 to 15 years. To be eligible to enter the trial, children:
- had 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);
- had an undetectable level of HIV virus in the blood.