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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 Treatment-Naive People With HIV-1

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Trial Profile

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 Treatment-Naive People With HIV-1

Status: Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 03 Apr 2026

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At a glance

  • Drugs Lenacapavir pacfosacil (Primary) ; Lepetegravir (Primary) ; Lepetegravir/lenacapavir pacfosacil (Primary) ; Bictegravir/emtricitabine/tenofovir alafenamide
  • Indications HIV-1 infections
  • Focus Therapeutic Use
  • Acronyms WONDERS2
  • Sponsors Gilead Sciences

Most Recent Events

  • 31 Mar 2026 Status changed from suspended to discontinued.
  • 10 Jun 2025 Status changed from active, no longer recruiting to suspended. The U.S. Food and Drug Administration has placed a clinical hold due to the identification of a safety signal of decreases in CD4+T-cell (CD4) and absolute lymphocyte counts in a subset of participants receiving the combination of GS-1720 and GS-4182.
  • 05 Jun 2025 Status changed from recruiting to active, no longer recruiting.

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