A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects Who Are Virologically Suppressed
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects Who Are Virologically Suppressed
The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance.
Key Inclusion Criteria:
Currently receiving an ARV regimen of DTG+F/TAF or DTG+F/TDF for the following minimum time periods:
Documented plasma HIV-1 ribonucleic acid (RNA) < 50 copies/mL during treatment with DTG+F/TAF or DTG+F/TDF (for a minimum period of ≥ 6 or ≥ 3 months, as applicable) preceding the screening visit
Plasma HIV-1 RNA levels < 50 copies/mL at screening visit
Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance
No documented resistance to integrase stand transfer inhibitors (INSTIs) or confirmed virologic failure
Eligible adults with chronic hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection are permitted to enroll
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Washington D.C., District of Columbia 20017, United States
Miami, Florida 33136, United States
Honolulu, Hawaii 96813, United States
Springfield, Massachusetts 01105, United States
Newark, New Jersey 07102, United States
Manhasset, New York 11030, United States
Chapel Hill, North Carolina 27514, United States
Greenville, North Carolina 27834, United States
Columbia, South Carolina 29203, United States
Winnipeg, Manitoba R3A 1R9, Canada
Montreal, Quebec H4A 3J1, Canada
Berlin, 12157, Germany
Bonn, 53127, Germany
Cologne, 50937, Germany
Essen, 45122, Germany
Frankfurt am Main, 60590, Germany
Hamburg, 20246, Germany