Clinical Research Directory

Key Inclusion Criteria: * Currently receiving a SBR defined as (1) integrase strand-transfer inhibitor (INSTI) + 1 or 2 nucleoside reverse transcriptase inhibitors (NRTIs) (excluding bictegravir/emtricitabine/tenofovir alafenamide (BIC/emtricitabine (FTC)/tenofovir alafenamide (TAF)), (2) boosted-protease inhibitor (PI) + 2 NRTIs, (3) nonnucleoside reverse transcriptase inhibitor (NNRTI) + 2 NRTIs, (4) dolutegravir (DTG)/RPV or (5) cabotegravir (CAB)/rilpivirine (RPV) for at least 3 months without switch prior to screening, and willing to continue their SBR through at least Week 24. * HIV-1 RNA \< 50 copies/mL for ≥ 3 months before screening * Estimated creatinine clearance (eCLcr) rate ≥ 15 mL/min according to the Cockcroft-Gault formula for creatinine clearance (CLcr) at screening * Plasma HIV-1 RNA levels \< 50 copies/mL at screening Key Exclusion Criteria: * Actively pregnant or breastfeeding (nursing) * Chronic hepatitis B virus (HBV) * Known hypersensitivity to the study drug, its metabolites, or formulation excipient. * Currently receiving renal replacement therapy (eg, hemodialysis) * Documented or suspected resistance to BIC * History of, or current severe decompensated cirrhosis * Requirement for ongoing therapy with any prohibited medications listed for BIC/LEN FDC * Prior use of, or exposure to, LEN * Ongoing treatment with BIC/FTC/TAF Note: Other protocol defined Inclusion/Exclusion criteria may apply.