BREATHER

Short-Cycle Therapy (SCT) (5 days on/2 days off) in young people with chronic HIV infection

Can HIV-infected children and young people taking efavirenz as one of their anti-HIV medicines take weekends off from their treatment?

What is this study about?

BREATHER is a study comparing two different ways for children and young people with HIV to take anti-HIV (antiretroviral) medicines when one of their treatments is a medicine called efavirenz:
1) Taking the medicines every day (as is usual).
2) Taking the medicines during the week for 5 days and then having a break for 2 days (i.e. no anti-HIV medicines) at the weekend.
This second way of taking the medicines is called Short Cycle Therapy (SCT).

The BREATHER study also asked children and young people for their views about these different ways of taking anti-HIV medicines. This study looked at how easy it is for children and young people to stick to each of the treatments and what influences them to take their medicines regularly. This part of the BREATHER study was carried out by the London School of Hygiene and Tropical Medicine.

The study also examined adherence to treatment and assessed the quality of life of the children and young people taking part.

Initial Results:

During the main study, most young people continued to have very low levels of HIV virus in their blood, whether taking anti-HIV medicines daily or following the SCT strategy. There was no evidence to suggest that more drug resistance developed as a result of taking drugs the medicines as SCT, and the number of side effects reported was similar in both groups of participants.

Whilst the initial results are exciting, participants were only followed up for one year.  To check that the SCT strategy is a viable option over a longer period of time, the trial has been extended for a further 2 years, where participants can remain on the strategy they were on during the main study.

The initial results from the main study were presented at the Conference of Retroviruses and Opportunistic Infections (CROI) in February 2015.

Type of study

Randomised trial

Contact details

penta.mrcctu@ucl.ac.uk

Who is funding the study?

The NIHR Health Technology Assessment Programme (UK Dept of Health) funded this study in the UK and Ireland. The PENTA Foundation funded the study in other countries that took part.

When is it taking place?

The main trial opened to recruitment in 2011 and was fully recruited in 2013.  The results of the main  trial will be published in 2015.  Given the 2 year extension to the trial, patients will be followed up until July 2016.

Where is it taking place?

The trial is taking place in hospital clinics in UK and Ireland, as well as other European countries, the United States, Argentina, Thailand, Brazil and Uganda.

Who is included?

199 children and young people aged between 8 and 24 years from Europe, Thailand, Uganda, Argentina and the USA. These young people were all currently taking anti-HIV medicines and had a very low level of virus in their blood.