PETRAM study

• Research type

  Research Study

• Full title

  Understanding changes in treatment-related regional bone turnover using 18F-fluoride-PET/CT in HIV-1-infected men: PETRAM study

• IRAS ID

  219478

• Contact name

  Sarah Pett

• Contact email

  s.pett@ucl.ac.uk

• Sponsor organisation

  University College London

• Clinicaltrials.gov Identifier

  2017-000677-36 , EudraCT

• Duration of Study in the UK

  1 years, 6 months, 1 days

• Research summary

  This is a single centre, 48 week study to explore the pathogenesis of HIV treatment related bone disease by using a novel imaging technique, 18F-Fluoride Positron Emission Tomography (18F-PET/CT), which measures regional bone formation. The study will include other standard methods (serum bone markers and DXA) for comparison. Patients enrolled will have baseline, week 24 and week 48 assessment, with baseline being the date of replacing tenofovir disoproxil fumarate (TDF) in their HIV treatment regimen with tenofavir alafenamide fumarate (TAF), compared to a control group continuing TDF. Allocation to change to TAF or continue TDF will be randomised to allow an unbiased assessment of bone changes. Both of these medications are licensed and standard antretroviral therapy for the treatment of HIV.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  17/LO/2018

• Date of REC Opinion

  11 Dec 2017

• REC opinion

  Favourable Opinion