Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed
- Conditions
- HIV-1-infection
- Interventions
- Registration Number
- NCT03110380
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 567
-
Currently receiving an ARV regimen of DTG+F/TAF or DTG+F/TDF for the following minimum time periods:
- ≥ 6 months (if there is documented or suspected nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance prior to the screening visit)
- ≥ 3 months (if there is no documented or suspected NRTI resistance prior to the screening visit)
-
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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B/F/TAF F/TAF Placebo Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination (FDC) tablet + dolutegravir (DTG) placebo tablet + emtricitabine/tenofovir alafenamide (F/TAF) placebo tablet administered without regard to food for at least 48 weeks. B/F/TAF B/F/TAF Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination (FDC) tablet + dolutegravir (DTG) placebo tablet + emtricitabine/tenofovir alafenamide (F/TAF) placebo tablet administered without regard to food for at least 48 weeks. DTG + F/TAF B/F/TAF Placebo DTG 50 mg tablet + F/TAF FDC tablet + B/F/TAF placebo tablet administered without regard to food for at least 48 weeks. B/F/TAF DTG Placebo Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination (FDC) tablet + dolutegravir (DTG) placebo tablet + emtricitabine/tenofovir alafenamide (F/TAF) placebo tablet administered without regard to food for at least 48 weeks. Open-label Phase B/F/TAF from B/F/TAF B/F/TAF Participants who received B/F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase. Open-label Phase B/F/TAF from DTG + F/TAF B/F/TAF Participants who received DTG + F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase. DTG + F/TAF F/TAF DTG 50 mg tablet + F/TAF FDC tablet + B/F/TAF placebo tablet administered without regard to food for at least 48 weeks. DTG + F/TAF DTG DTG 50 mg tablet + F/TAF FDC tablet + B/F/TAF placebo tablet administered without regard to food for at least 48 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm Week 48 The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm Week 48 The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Change From Baseline in CD4+ Cell Count at Week 48 Baseline; Week 48
Trial Locations
- Locations (92)
Instituto de Investigacion Cientifica del Sur
🇵🇷Ponce, Puerto Rico
Proyecto ACTU
🇵🇷San Juan, Puerto Rico
Mills Clinical Research
🇺🇸Los Angeles, California, United States
Triple O Research Institute, P.A.
🇺🇸West Palm Beach, Florida, United States
Emory Hospital Midtown Infectious Disease Clinic
🇺🇸Atlanta, Georgia, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Infectious Disease Specialists of Atlanta
🇺🇸Decatur, Georgia, United States
Mercer University, Department of Internal Medicine
🇺🇸Macon, Georgia, United States
Be Well Medical Center
🇺🇸Berkley, Michigan, United States
Prime Healthcare Services - St. Michael's LLC d/b/a Saint Michael's Medical Center
🇺🇸Newark, New Jersey, United States
North Shore University Hospital/Division of Infectious Diseases
🇺🇸Manhasset, New York, United States
East Carolina University (ECU), The Brody School of Medicine, Adult Specialty Care
🇺🇸Greenville, North Carolina, United States
AIDS Arms Inc/ Trinity Health and Wellness Center
🇺🇸Dallas, Texas, United States
Maple Leaf Research / Maple Leaf Medical Clinic
🇨🇦Toronto, Ontario, Canada
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Community Research Initiative of New England
🇺🇸Boston, Massachusetts, United States
Therapeutic Concepts, PA
🇺🇸Houston, Texas, United States
The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA)
🇺🇸Houston, Texas, United States
Peter Shalit, M.D.
🇺🇸Seattle, Washington, United States
University of Miami Divison of Infectious Diseases Clinical Research Unit
🇺🇸Miami, Florida, United States
Abbott Northwestern Hospital part of Allina Health
🇺🇸Minneapolis, Minnesota, United States
Duke University Heath System
🇺🇸Durham, North Carolina, United States
Kaiser Permanente
🇺🇸San Francisco, California, United States
Hennepin County Medical Center, Positive Care Clinic
🇺🇸Minneapolis, Minnesota, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Spectrum Medical Group
🇺🇸Phoenix, Arizona, United States
Infektiologikum Frankfurt
🇩🇪Frankfurt am Main, Germany
Gary J. Richmond, M.D., P.A.
🇺🇸Fort Lauderdale, Florida, United States
CHU de Nice-l'Archet
🇫🇷Nice, France
Therafirst Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Whitman-Walker Institute
🇺🇸Washington, District of Columbia, United States
The GW Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
AHF-Pensacola
🇺🇸Pensacola, Florida, United States
Midland Florida Clinical Research Center, LLC
🇺🇸DeLand, Florida, United States
AIDS Healthcare Foundation - South Beach
🇺🇸Miami Beach, Florida, United States
Midway Immunology and Research Center
🇺🇸Fort Pierce, Florida, United States
AIDS Research and Treatment Center of the Treasure Coast
🇺🇸Vero Beach, Florida, United States
CHU Bichat
🇫🇷Paris, France
Dupont Circle Physician's Group
🇺🇸Washington, District of Columbia, United States
Providence Hospital Center for Infectious Diseases
🇺🇸Washington, District of Columbia, United States
ICH Study Center GmbH & Co. KG
🇩🇪Hamburg, Germany
Hôpital Saint-André
🇫🇷Bordeaux, France
Palmetto Health Richland (Regulatory and Study Supply Shipping)
🇺🇸Columbia, South Carolina, United States
Hope Clinical Research
🇵🇷San Juan, Puerto Rico
zibp Zentrum für Infektiologie Berlin Prenzlauer Berg
🇩🇪Berlin, Germany
University of Colorado Denver, University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Infectious Disease Research Institute Inc
🇺🇸Tampa, Florida, United States
St. Joseph's Hospital Comprehensive Research Institute
🇺🇸Tampa, Florida, United States
Ruane Clinical Research Group Inc.
🇺🇸Los Angeles, California, United States
Highland Hospital - Alameda Health System
🇺🇸Oakland, California, United States
Hepatitis/HIV Clinical Trials Group (HHCTG)
🇺🇸San Francisco, California, United States
Kaiser Permanente, Department of Infectious Diseases
🇺🇸San Leandro, California, United States
AU Medical Center
🇺🇸Augusta, Georgia, United States
Chatham County Health Department
🇺🇸Savannah, Georgia, United States
Metro West Medical Center
🇺🇸Framingham, Massachusetts, United States
Claudia T Martorell, MD., LLC d/b/a The Research Institute
🇺🇸Springfield, Massachusetts, United States
Southwest CARE Center
🇺🇸Santa Fe, New Mexico, United States
Southampton Healthcare, Inc.
🇺🇸Saint Louis, Missouri, United States
Rosedale Infectious Diseases
🇺🇸Huntersville, North Carolina, United States
Research Access Network
🇺🇸Houston, Texas, United States
North Texas Infectious Diseases Consultants, P.A.
🇺🇸Dallas, Texas, United States
MultiCare Rockwood HIV Critical Care Clinic
🇺🇸Spokane, Washington, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States
Kaye Edmonton Clinic
🇨🇦Edmonton, Alberta, Canada
Spectrum Health Clinic
🇨🇦Vancouver, British Columbia, Canada
Medizinische Universitat Wien, Universitatsklinik fur Dermatologie
🇦🇹Wien, Austria
AP-HP Hôpital Tenon
🇫🇷Paris, France
Chronical Viral Illness Service/McGill University Health Care (MUHC)
🇨🇦Montréal, Quebec, Canada
Clinique de Médecine Urbaine du Quartier Latin
🇨🇦Montréal, Quebec, Canada
Hôpital Gui de Chauliac, CHU de Montpellier
🇫🇷Montpellier, France
Hôpital Croix-Rousse
🇫🇷Lyon, France
Hôpital Saint-Louis
🇫🇷Paris, France
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Klinisches Studienzentrum Immunologie
🇩🇪Bonn, Germany
Hôpital Saint-Antoine
🇫🇷Paris, France
EPIMED Gesellschaft fur epidemiologische und klinische Forschung in der Medizin mbH
🇩🇪Berlin, Germany
Universitätsklinikum Köln - Klinik I fur Innere Medizin - Klinisches Studienzentrum fur Infektiologie I
🇩🇪Cologne, Germany
Universitätsklinikum Essen - Klinik fur Dermatologie und Venerologie - HPSTD Ambulanz
🇩🇪Essen, Germany
Universitätsklinikum Frankfurt, Medizinische Klinik II, Schwerpunkt Infektiologie, Haus 68
🇩🇪Frankfurt am Main, Germany
Universitätsklinikum Hamburg- Eppendorf - Ambulanzzentrum des Universitatsklinikums Eppendorf GmbH - Bereich Infektiologie
🇩🇪Hamburg, Germany
Clinical Research Puerto Rico
🇵🇷San Juan, Puerto Rico
Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg
🇨🇦Winnipeg, Manitoba, Canada
Cares Community Health
🇺🇸Sacramento, California, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
John A. Burns School of Medicine, University of Hawaii Clinics at Kaka'ako
🇺🇸Honolulu, Hawaii, United States
University of Louisville 550 Clinic
🇺🇸Louisville, Kentucky, United States
Kansas City CARE Clinic
🇺🇸Kansas City, Missouri, United States
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
Medical University of South Carolina (MUSC)
🇺🇸Charleston, South Carolina, United States
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
Jacobi Medical Center
🇺🇸Bronx, New York, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States