Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen

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

Time frame · Week 24

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

Time frame · Week 48

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

Time frame · Week 24

Phase 2: Change From Baseline in CD4 Cell Count at Week 24

Time frame · Baseline, Week 24

Phase 2: Percentage of Participants Experiencing Treatment-emergent Adverse Events (AEs) Through Week 24

Time frame · First dose date up to Week 24

Phase 2: Pharmacokinetic (PK) Parameter: Cmax of Bictegravir (BIC) and Lenacapavir (LEN) at Steady State

Time frame · Day 1 up to Week 24

Cmax is defined as the maximum observed concentration of drug.

Phase 2: PK Parameter: AUCtau of BIC and LEN at Steady State

Time frame · Day 1 up to Week 24

AUCtau is defined as the area under the concentration versus time curve over the dosing interval.

Phase 2: PK Parameter: Ctau of BIC and LEN at Steady State

Time frame · Day 1 up to Week 24

Ctau is defined as the observed drug concentration at the end of the dosing interval.

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

Time frame · Week 48

Phase 3: Change From Baseline in CD4 Cell Count at Week 48

Time frame · Baseline, Week 48

Phase 3 (BIC/LEN 75 mg/50 mg FDC): Proportion of Participants from With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm

Time frame · Week 96

Phase 3 (BIC/LEN 75 mg/50 mg FDC): Change From Baseline in CD4 Cell Count at Week 96

Time frame · Baseline, Week 96