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
NCT ID: NCT03110380
Last Updated: 2022-01-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
567 participants
INTERVENTIONAL
2017-06-12
2021-02-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
B/F/TAF
50/200/25 mg FDC tablet(s) administered orally once daily
DTG Placebo
Tablet(s) administered orally once daily
F/TAF Placebo
Tablet(s) administered orally once daily
DTG + 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.
F/TAF
200/25 mg FDC tablet(s) administered orally once daily
DTG
50 mg tablet(s) administered orally once daily
B/F/TAF Placebo
Tablet(s) administered orally once daily
Open-label Phase B/F/TAF from 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.
B/F/TAF
50/200/25 mg FDC tablet(s) administered orally once daily
Open-label Phase B/F/TAF from DTG + 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.
B/F/TAF
50/200/25 mg FDC tablet(s) administered orally once daily
Interventions
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B/F/TAF
50/200/25 mg FDC tablet(s) administered orally once daily
F/TAF
200/25 mg FDC tablet(s) administered orally once daily
DTG
50 mg tablet(s) administered orally once daily
DTG Placebo
Tablet(s) administered orally once daily
F/TAF Placebo
Tablet(s) administered orally once daily
B/F/TAF Placebo
Tablet(s) administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥ 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Spectrum Medical Group
Phoenix, Arizona, United States
Ruane Clinical Research Group Inc.
Los Angeles, California, United States
Mills Clinical Research
Los Angeles, California, United States
Highland Hospital - Alameda Health System
Oakland, California, United States
Cares Community Health
Sacramento, California, United States
Kaiser Permanente
Sacramento, California, United States
Hepatitis/HIV Clinical Trials Group (HHCTG)
San Francisco, California, United States
Kaiser Permanente
San Francisco, California, United States
Kaiser Permanente, Department of Infectious Diseases
San Leandro, California, United States
University of Colorado Denver, University of Colorado Hospital
Aurora, Colorado, United States
Whitman-Walker Institute
Washington D.C., District of Columbia, United States
Dupont Circle Physician's Group
Washington D.C., District of Columbia, United States
Providence Hospital Center for Infectious Diseases
Washington D.C., District of Columbia, United States
The GW Medical Faculty Associates
Washington D.C., District of Columbia, United States
Midland Florida Clinical Research Center, LLC
DeLand, Florida, United States
Therafirst Medical Center
Fort Lauderdale, Florida, United States
Gary J. Richmond, M.D., P.A.
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
University of Miami Divison of Infectious Diseases Clinical Research Unit
Miami, Florida, United States
AIDS Healthcare Foundation - South Beach
Miami Beach, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
AHF-Pensacola
Pensacola, Florida, United States
Infectious Disease Research Institute Inc
Tampa, Florida, United States
St. Joseph's Hospital Comprehensive Research Institute
Tampa, Florida, United States
AIDS Research and Treatment Center of the Treasure Coast
Vero Beach, Florida, 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
AU Medical Center
Augusta, Georgia, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States
Mercer University, Department of Internal Medicine
Macon, Georgia, United States
Chatham County Health Department
Savannah, Georgia, 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
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Community Research Initiative of New England
Boston, Massachusetts, 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
Be Well Medical Center
Berkley, Michigan, United States
Abbott Northwestern Hospital part of Allina Health
Minneapolis, Minnesota, United States
Hennepin County Medical Center, Positive Care Clinic
Minneapolis, Minnesota, United States
Kansas City CARE Clinic
Kansas City, Missouri, United States
Southampton Healthcare, Inc.
St Louis, Missouri, United States
Prime Healthcare Services - St. Michael's LLC d/b/a Saint Michael's Medical Center
Newark, New Jersey, United States
Southwest CARE Center
Albuquerque, New Mexico, United States
Southwest CARE Center
Santa Fe, New Mexico, United States
North Shore University Hospital/Division of Infectious Diseases
Manhasset, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Heath System
Durham, North Carolina, United States
East Carolina University (ECU), The Brody School of Medicine, Adult Specialty Care
Greenville, North Carolina, United States
Rosedale Infectious Diseases
Huntersville, 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
Palmetto Health Richland (Regulatory and Study Supply Shipping)
Columbia, South Carolina, United States
Central Texas Clinical Research
Austin, Texas, United States
AIDS Arms Inc/ Trinity Health and Wellness Center
Dallas, Texas, United States
North Texas Infectious Diseases Consultants, P.A.
Dallas, Texas, United States
Therapeutic Concepts, PA
Houston, Texas, United States
Research Access Network
Houston, Texas, United States
The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA)
Houston, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
Peter Shalit, M.D.
Seattle, Washington, United States
MultiCare Rockwood HIV Critical Care Clinic
Spokane, Washington, United States
Medizinische Universitat Wien, Universitatsklinik fur Dermatologie
Vienna, , Austria
Kaye Edmonton Clinic
Edmonton, Alberta, Canada
Spectrum Health Clinic
Vancouver, British Columbia, Canada
Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg
Winnipeg, Manitoba, Canada
Maple Leaf Research / Maple Leaf Medical Clinic
Toronto, Ontario, Canada
Clinique de Médecine Urbaine du Quartier Latin
Montreal, Quebec, Canada
Chronical Viral Illness Service/McGill University Health Care (MUHC)
Montreal, Quebec, Canada
Hôpital Saint-André
Bordeaux, , France
Hôpital Croix-Rousse
Lyon, , France
Hôpital Gui de Chauliac, CHU de Montpellier
Montpellier, , France
CHU de Nice-l'Archet
Nice, , France
CHU Bichat
Paris, , France
AP-HP Hôpital Tenon
Paris, , France
Hôpital Saint-Louis
Paris, , France
Hôpital Saint-Antoine
Paris, , France
zibp Zentrum für Infektiologie Berlin Prenzlauer Berg
Berlin, , Germany
EPIMED Gesellschaft fur epidemiologische und klinische Forschung in der Medizin mbH
Berlin, , Germany
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Klinisches Studienzentrum Immunologie
Bonn, , 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
Infektiologikum Frankfurt
Frankfurt am Main, , Germany
ICH Study Center GmbH & Co. KG
Hamburg, , Germany
Universitätsklinikum Hamburg- Eppendorf - Ambulanzzentrum des Universitatsklinikums Eppendorf GmbH - Bereich Infektiologie
Hamburg, , Germany
Instituto de Investigacion Cientifica del Sur
Ponce, , Puerto Rico
Hope Clinical Research
San Juan, , Puerto Rico
Proyecto ACTU
San Juan, , Puerto Rico
Clinical Research Puerto Rico
San Juan, , Puerto Rico
Countries
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References
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Sax PE, Rockstroh JK, Luetkemeyer AF, Yazdanpanah Y, Ward D, Trottier B, Rieger A, Liu H, Acosta R, Collins SE, Brainard DM, Martin H; GS-US-380-4030 Investigators. Switching to Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Virologically Suppressed Adults With Human Immunodeficiency Virus. Clin Infect Dis. 2021 Jul 15;73(2):e485-e493. doi: 10.1093/cid/ciaa988.
Acosta RK, Willkom M, Andreatta K, Liu H, Martin R, Parvangada A, Martin H, Collins S, White KL. Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) From Dolutegravir (DTG)+F/TAF or DTG+F/Tenofovir Disoproxil Fumarate (TDF) in the Presence of Pre-existing NRTI Resistance. J Acquir Immune Defic Syndr. 2020 Nov 1;85(3):363-371. doi: 10.1097/QAI.0000000000002454.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-000308-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-380-4030
Identifier Type: -
Identifier Source: org_study_id
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