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An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens

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Trial Profile

An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 08 May 2026

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At a glance

  • Drugs Bictegravir (Primary) ; Bictegravir/lenacapavir (Primary) ; Lenacapavir (Primary) ; Abacavir; Atazanavir; Cabotegravir; Darunavir; Delavirdine; Dolutegravir; Doravirine; Efavirenz; Elvitegravir; Emtricitabine; Enfuvirtide; Fosamprenavir; Fostemsavir; Ibalizumab; Indinavir; Lamivudine; Lopinavir; Maraviroc; Nelfinavir; Nevirapine; Raltegravir; Rilpivirine; Saquinavir; Tenofovir alafenamide; Tenofovir disoproxil fumarate; Tipranavir; Zidovudine
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms ARTISTRY-1
  • Sponsors Gilead Sciences

Most Recent Events

  • 29 Apr 2026 According to a Gilead Sciences media release, based on the data from ARTISTRY-1 (NCT05502341) and ARTISTRY-2 (NCT06333808) trials, The FDA has granted priority review of the application and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 27, 2026.
  • 29 Apr 2026 According to a Gilead Sciences media release, the U.S. FDA has accepted its New Drug Application (NDA) submission for bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) for the treatment of HIV in adults who are virologically suppressed based on the data from ARTISTRY-1 (NCT05502341) and ARTISTRY-2 (NCT06333808) trials.
  • 25 Feb 2026 According to a Gilead Sciences media release, The new data, from the ARTISTRY-1 (NCT05502341) and ARTISTRY-2 (NCT06333808) trials, assessed the safety and efficacy of the once-daily single tablet regimen of BIC/LEN and were presented during late-breaker sessions at the 33rd Conference on Retroviruses and Opportunistic Infections in Denver, Colorado. The findings build on the positive topline results announced in November and December 2025.

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