GS 0115 Open label cobicistat regimen in HIV

• Research type

  Research Study

• Full title

  A Phase 3b Randomized, Open Label Study to Evaluate Switching from Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI/r) plus Emtricitabine/Tenofovir Fixed-Dose Combination (FTC/TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients

• IRAS ID

  92395

• Contact name

  Martin Fisher

• Sponsor organisation

  Gilead Sciences Inc

• Eudract number

  2011-004483-30

• Clinicaltrials.gov Identifier

  103,093, IND number

• Duration of Study in the UK

  2 years, 0 months, 0 days

• Research summary

  This is a phase 3b randomised, open-label study funded by Gilead Sciences. The research study is being conducted to investigate the safety and efficacy of switching from an antiretroviral (ARV) regimen consisting of a ritonavir-boosted protease inhibitor (PI/r) plus FTC/TDF to the elvitegravir/cobicistat/emtricitabine/tenofovir df single tablet regimen (EVG/COBI/FTC/TDF) in virogically-suppressed HIV-1 infected patients.
  
  Approximately 420 patients worldwide who are currently receiving their first ARV regimen consisting of PI/r plus FTC/TDF, have undetectable plasma HIV-1 RNA levels, and have a documented historical genotypic sensitivity to FTC and TDF will be recruited in this study. Approximately 15 participants will be recruited in the UK. The duration of participation could be up to 2 years.
  
  Participants will be randomised 2;1 to receive one of the following two study treatments:
  Study Treatment Arm 1: 280 participants will switch to EVG/COBI/FTC/TDF for 48 weeks. If after 48 weeks EVG/COBI/FTC/TDF is not yet commercially available in the UK, participants will have the option to enter an extension phase of the trial and will continue to receive EVG/COBI/FTC/TDF for a further 48 weeks (or until EVG/COBI/FTC/TDF is commercially available in the UK or until Gilead stops development of the drug.
  Study Treatment Arm 2: 140 participants will remain on their current ARV regimen consisting of PI/r plus FTC/TDF for 48 weeks. If after 48 weeks EVG/COBI/FTC/TDF STR is not yet commercially available in the UK, participants will have the option to enter an extension phase of the trial to switch to EVG/COBI/FTC/TDF for 48 weeks (or until EVG/COBI/FTC/TDF is commercially available in the UK or until Gilead stops development of the drug).

  This study requires up to 16 clinic visits (including the extension phase) and involves procedures including vital signs, physical exams, laboratory tests and participant questionnaires.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  11/SC/0523

• Date of REC Opinion

  25 Jan 2012

• REC opinion

  Further Information Favourable Opinion