BREATHER(PENTA 16) Trial: Short-Cycle Therapy(SCT)

• Research type

  Research Study

• Full title

  BREATHER (PENTA 16): Short-cycle therapy (SCT) (5 days on/ 2 days off) in young people with chronic HIV-infection

• IRAS ID

  22220

• Contact name

  Diana M Gibb

• Sponsor organisation

  LSHTM

• Eudract number

  2009-012947-40

• ISRCTN Number

  ISRCTN97755073

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The overall aim is to evaluate whether young people with well-managed HIV disease can have 2 days per week without medication (called short cycle therapy, SCT) and still keep the virus at a very low level. Although data from adult trials of SCT is encouraging, because of insufficient data on SCT in children and young people, there will be an initial pilot phase in selected centres, to assess the safety of this strategy. 160 HIV-1 infected males and females aged 8-21 years will be recruited from paediatric and adolescent hospital clinics in the UK and other European countries as well as Brazil, Thailand, and Uganda, and randomised into two groups: 1. Continuous ART 2. Short-Cycle therapy (5 days on ART (Mon-Fri or Sun-Thurs) and 2 days off (Sat-Sun or Fri-Sat). Participants will be seen for clinic visits until the last young person recruited has completed 48 weeks of follow-up. Measures such as height, weight, tanner scales and blood tests are part of their normal routine visit however they will also be asked to complete questionnaires and attend more regular visits for the first 12 weeks. The adherence (MEMS cap) substudy will be carried out in a subset of 60 participants from the UK and Uganda. The study will use Medication Event Monitoring Systems (MEMS) to measure adherence to the protocol for both arms of the trial. The qualitative substudy aims to understand the way in which SCT is experienced and valued and looks at the factors that may hinder SCT implementation into routine therapy through interviews, audio diaries and focus groups in 40 participants (20 from UK, 20 from Uganda), exploring how young people understand and orientate to the process of adaption and the acceptability of the SCT against continuous treatment along with lifestyle and contextual factors linked to adherence. The trial is funded by the NIHR Health Technology Assessment for UK and Ireland sites only. Funding for other countries will be from the PENTA Foundation.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  10/H0714/8

• Date of REC Opinion

  9 Feb 2010

• REC opinion

  Favourable Opinion