Wonders 1: Study of GS-1720 with GS-4182 vs Biktarvy in HIV-1

• Research type

  Research Study

• Full title

  An Operationally Seamless Phase 2/3, Randomized, Active -Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination With GS-4182 Versus Biktarvy in Virologically Suppressed People With HIV-1

• IRAS ID

  1010901

• Contact name

  Elena Vendrame

• Contact email

  elena.vendrame@gilead.com

• Sponsor organisation

  Gilead Sciences, Inc

• Eudract number

  2024-511054-50

• Clinicaltrials.gov Identifier

  NCT06544733

• Research summary

  While current treatment of HIV-1 infection is efficacious and well tolerated, these agents need to be taken daily and require near-perfect adherence to minimize the emergence of drug-resistant variants. “Treatment fatigue” can occur which can lead to nonadherence and treatment failure. There remains a significant medical need for treatment that can be taken less frequently. This proposed study is a phase 2/3 randomized active-controlled study comparing the safety and efficacy of switching to a once weekly oral regimen of GS-1720 in combination with GS-4182 vs continuing with once daily Biktarvy.

  The study will evaluate the safety and tolerability of the study drug using physical exams, , ECG, blood tests, urinalysis and reviewing any symptoms or problems participants might experience during the study.
  This is a multi-centre, global study where about 675 participants will take part in around 115 locations, including the UK. The study will consist of phase 2 and phase 3 parts.

  Phase 2: Participants will be randomized to one of 2 treatment groups. Group 1 will switch from current Biktarvy treatment to GS-1720 and GS-4182 given as separate weekly pills. Group 2 will continue current treatment with daily Biktarvy. After a 48-week treatment period participants will be offered the chance to enter an extension period where all participants will receive once weekly GS-1720/GS-4182 until the study drugs become commercially available or until the sponsor ends the study.

  Phase 3: Participants will be randomized (50/50) to one of 2 treatment groups. Group 1 participants will switch from current daily Biktarvy treatment to once weekly GS-1720/GS-4182 plus daily Biktarvy placebo. Group 2: participants will continue current daily Biktarvy treatment plus GS-1720/GS-4182 weekly placebo. After a 96-week treatment period participants will be offered the chance to enter an extension period as described above.

• REC name

  London - Central Research Ethics Committee

• REC reference

  24/LO/0821

• Date of REC Opinion

  21 Jan 2025

• REC opinion

  Further Information Favourable Opinion