ARTISTRY-2: Phase 3 study of Bictegravir/Lenacapavir vs Biktarvy in people with HIV-1

• Research type

  Research Study

• Full title

  Phase 3 Double-blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy ® (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1

• IRAS ID

  1009776

• Contact name

  Christiaan de Vries

• Contact email

  christiaan.devries@gilead.com

• Sponsor organisation

  Gilead Sciences, Inc

• Eudract number

  2023-510022-33

• Research summary

  There is an unmet need for new safe and effective treatment options for all people with HIV-1, including those who are virologically suppressed. To that end, Gilead is developing a once-daily fixed-dose combination (FDC) tablet of Bictegravir (BIC) in combination with Lenacapavir (LEN) which would represent another single-tablet-regimen (STR) option for people with HIV-1 who are virologically suppressed.
  The proposed study will evaluate the safety and efficacy of BIC/LEN versus current therapy in virologically suppressed people with HIV-1 who are successfully treated with Biktarvy (B/T/TAF).
  
  We will find out about the safety of this study drug, how well it’s tolerated, and how long it stays in the body using physical exams, laboratory tests, ECG, blood analysis, and any symptoms or problems participants might experience during the study.
  
  This research study will be conducted in a multicentre setting across the globe, where about 546 participants will take part in around 120 locations, including the UK.
  
  This study will consist of a 48-week blinded phase followed by a 48-week open-label phase. During the blinded phase participants will be randomized in a 2:1 ratio to either Group 1: switch from B/F/TAF standard of care treatment to BIC/LEN plus placebo or Group 2: continue with B/F/TAF plus placebo. During the open-label phase Group 1 participants will continue to take BIC/LEN and Group 2 participants will be given BIC/LEN

• REC name

  London - City & East Research Ethics Committee

• REC reference

  24/LO/0266

• Date of REC Opinion

  15 May 2024

• REC opinion

  Further Information Favourable Opinion