WONDERS1Ensayo clínico de GS-1720 y GS-4182 en pacientes con VIH-1 virológicamente suprimidos

GS-1720

GS-4182

Placebo to Match BVY

GS-1720/GS-4182 FDC

Bictegravir/emtricitabine/tenofovir alafenamide

Bictegravir/emtricitabine/tenofovir alafenamide

Placebo to Match GS1720/GS-4182 FDC

GS-1720/GS-4182 FDC

GS-1720/GS-4182 FDC

Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by the United States (US) Food and Drug Administration (FDA)-defined Snapshot Algorithm

Phase 3: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm

Phase 3: Proportion of Participants Experiencing TEAEs Through Week 96

Phase 3: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 48

Phase 3: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 96

Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm

Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm

Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm

Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm

Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm

Phase 2: Change From Baseline in Clusters of Differentiation 4 (CD4+) T-cell Count at Week 12

Phase 2: Change From Baseline in CD4+ T-cell Count at Week 24

Phase 2: Change From Baseline in CD4+ T-cell Count at Week 48

Phase 2: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) Through Week 12

Phase 2: Percentage of Participants Experiencing TEAEs Through Week 24

Phase 2: Percentage of Participants Experiencing TEAEs Through Week 48

Phase 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 12

Phase 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 24

Phase 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 48

Phase 2: Pharmacokinetic (PK) Parameter: Cmax of GS-1720 and Lenacapavir (LEN)

Phase 2: PK Parameter: Tmax of GS-1720 and LEN

Phase 2: PK Parameter: Ctau of GS-1720 and LEN

Phase 2: PK Parameter: AUCtau of GS-1720 and LEN

Phase 3: Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm

Phase 3: Proportion of Participants With HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm

Phase 3: Proportion of Participants With HIV-1 RNA < 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm

Phase 3: Change From Baseline in CD4+ T-cell Count at Week 48

Phase 3: Change From Baseline in CD4+ T-cell Count at Week 96

Phase 3: Percentage of Participants Experiencing TEAEs Through Week 48