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

Human Immunodeficiency Virus (HIV-1) infection

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 2: Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 24 as determined by the US FDA-defined snapshot algorithm., Change from baseline in CD4 cell count at Week 24, Proportion of participants experiencing treatment-emergent adverse events (AEs) through Week 24, PK parameters Cmax, AUCtau, and Ctau (as applicable) of BIC and LEN, Phase 3: Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 48 as determined by the US FDA–defined snapshot algorithm., Change from baseline in CD4 cell count at Weeks 48., Proportion of participants experiencing treatment-emergent AEs through Week 48., Proportion of participants from Treatment Group 1 with HIV-1 RNA ≥ 50 copies/mL at Week 96 as determined by the US FDA-defined snapshot algorithm, Change from baseline in CD4 cell count at Week 96 for participants from Treatment Group 1, Proportion of participants from Treatment Group 1 experiencing treatment-emergent AEs through Week 96

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