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: Suspended

Phase of Trial: Phase II/III

Latest Information Update: 12 Jun 2025

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At a glance

Drugs GS 1720 (Primary) ; GS 4182 (Primary) ; Bictegravir/emtricitabine/tenofovir alafenamide
Indications HIV-1 infections
Focus Therapeutic Use
Acronyms WONDERS2
Sponsors Gilead Sciences

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.
23 Oct 2024 Status changed from not yet recruiting to recruiting.

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