HIV Once Daily ARV Single Tablet bPI regimen naïve patients - AMBER

• Research type

  Research Study

• Full title

  A Phase 3, randomized, active-controlled, double-blind study to evaluate efficacy and safety of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) once daily fixed dose combination regimen versus a regimen consisting of darunavir/cobicistat fixed dose combination coadministered with emtricitabine/tenofovir disoproxil fumarate fixed dose combination in antiretroviral treatment-naïve human immunodeficiency virus type 1 infected subjects.

• IRAS ID

  184169

• Contact name

  Chloe Orkin

• Contact email

  chloe.orkin@bartsandthelondon.nhs.uk

• Sponsor organisation

  Janssen Research and Development, Global Clinical Operations

• Eudract number

  2015-000754-38

• Clinicaltrials.gov Identifier

  NCT02431247

• Duration of Study in the UK

  2 years, 7 months, 28 days

• Research summary

  The AMBER study (TMC114FD2HTX3001) is a phase 3, randomized, active controlled, double blind study. Its purpose is to evaluate efficacy and safety of a fixed dose combination treatment (one tablet a day) in patients who have not previously received treatment for their HIV-1 (human immunodeficiency virus type 1).

  There will be a screening visit followed by eight clinic visits over 48 weeks. Participants will be randomised in a 1:1 ratio to one of the two treatment groups:

  - Fixed Dose Combination D/C/F/TAF group : a single-tablet containing a combination of drugs Darunavir (D) 800 mg/ Cobicistat (C) 150 mg/ Emtricitabine (F) 200 mg/ Ténofovir alafenamide (TAF) 10 mg once daily + Darunavir/Cobicistat (Rezolsta®) matching placebo and Emtricitabine/ Tenofovir disoproxil fumarate (Truvada®) matching placebo tablets once daily;
  or Active Control group: Fixed Dose Combination of Darunavir 800 mg/Cobicistat 150 mg coadministered with Emtricitabine 200mg/ Tenofovir disoproxil fumarate (Truvada®) 300 mg + D/C/F/TAF matching placebo tablet once daily.
  After Week 48, patients will continue to take their study drug in a blinded way and attend visits every 12 weeks until all patients have reached Week 48, the database for the primary analysis has been locked, and the physicians are informed which treatment their patients received. Based on the results of the primary analysis all patients (both groups) will be invited to return for a study visit called unblinding visit and will receive treatment with the D/C/F/TAF fixed dose combination tablet treatment during an open label single group treatment phase up to Week 96

  After 96 weeks patients may continue treatment in the extension phase in which all participants will be have the option to receive the experimental treatment D/C/F/TAF.

  Study assessments include blood and urine testing, physical examination, electrocardiogram (ECG), vital signs and weight measurement, assessment of adherence to treatment and adverse events. Participants will receive a logbook for recording all their treatment doses until Week 96.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  15/LO/1239

• Date of REC Opinion

  14 Aug 2015

• REC opinion

  Favourable Opinion