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Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Adults Who Are Virologically Suppressed

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ClinicalTrials.gov Identifier: NCT03110380
Recruitment Status : Active, not recruiting
First Posted : April 12, 2017
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
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 (Emtriva®)/tenofovir alafenamide (Descovy®; F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (Truvada®; F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy®; B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance as determined by the proportion of participants with human immunodeficiency virus-1 ribonucleic acid (HIV-1 RNA) ≥ 50 copies/mL at Week 48

Condition or disease Intervention/treatment Phase
HIV-1-infection Drug: B/F/TAF Drug: F/TAF Drug: DTG Drug: DTG Placebo Drug: F/TAF Placebo Drug: B/F/TAF Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 567 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: B/F/TAF
B/F/TAF + DTG placebo + F/TAF placebo for 48 Weeks
Drug: B/F/TAF
50/200/25 mg FDC tablet(s) administered orally once daily
Other Names:
  • GS-9883/F/TAF
  • Biktarvy®

Drug: DTG Placebo
Tablet(s) administered orally once daily

Drug: F/TAF Placebo
Tablet(s) administered orally once daily

Active Comparator: DTG + F/TAF
DTG + F/TAF + B/F/TAF placebo for 48 Weeks
Drug: F/TAF
200/25 mg FDC tablet(s) administered orally once daily
Other Name: Descovy®

Drug: DTG
50 mg tablet(s) administered orally once daily
Other Name: Tivicay®

Drug: B/F/TAF Placebo
Tablet(s) administered orally once daily




Primary Outcome Measures :
  1. Proportion of participants with virologic failure (HIV-1 RNA ≥ 50 copies/mL) as defined by the modified US FDA-defined snapshot algorithm [ Time Frame: Week 48 ]

Secondary Outcome Measures :
  1. Proportion of participants with HIV-1 RNA < 50 copies/mL as defined by the US FDA-defined snapshot algorithm [ Time Frame: Week 48 ]
  2. Change from Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Week 48 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110380


  Hide Study Locations
Locations
United States, Arizona
Spectrum Medical Group
Phoenix, Arizona, United States, 85012
United States, California
Peter J. Ruane MD, Inc.
Los Angeles, California, United States, 90036
Mills Clinical Research
Los Angeles, California, United States, 90069
Highland Hospital - Alameda Health System
Oakland, California, United States, 94602
University of California Davis
Sacramento, California, United States, 95817
Kaiser Permanente
Sacramento, California, United States, 95825
Positive Health Program SF General Hospital
San Francisco, California, United States, 94110
Kaiser Permanente
San Francisco, California, United States, 94118
Kaiser Permanente
San Leandro, California, United States, 94577
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, District of Columbia
Dupont Circle Physicians Group
Washington, District of Columbia, United States, 20009
Providence Hospital Center for Infectious Disease
Washington, District of Columbia, United States, 20017
Providence Hospital
Washington, District of Columbia, United States, 20017
The George Washington University
Washington, District of Columbia, United States, 20037
United States, Florida
Midland Florida Clinical Research Center, LLC
DeLand, Florida, United States, 32720
Therafirst Medical Centers
Fort Lauderdale, Florida, United States, 33308
Gary J. Richmond,M.D.,P.A.
Fort Lauderdale, Florida, United States, 33316
Midway Immunology & Research Center, LLC
Fort Pierce, Florida, United States, 34982
Michael S. Somero MD A Professional Corporation
Miami Beach, Florida, United States, 33140
University of Miami Division of Infectious Diseases Clinical Research Unit
Miami, Florida, United States, 33136
Orlando Immunology Center
Orlando, Florida, United States, 32803
AIDS Healthcare Foundation
Pensacola, Florida, United States, 32503
Infectious Disease Research Institute Inc.
Tampa, Florida, United States, 33614
St. Josephs Comprehensive Research Institute
Tampa, Florida, United States, 33614
AIDS Research & Treatment Center of the Treasure Coast
Vero Beach, Florida, United States, 32960
Triple O Research Institute PA
West Palm Beach, Florida, United States, 33407
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30308
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30312
Augusta University Research Institute
Augusta, Georgia, United States, 30912
Infectious Disease Specialists of Atlanta, PC
Decatur, Georgia, United States, 30033
Mercer University School of Medicine
Macon, Georgia, United States, 31201
Chatham County Health Department
Savannah, Georgia, United States, 31401
United States, Hawaii
John A. Burns School of Medicine, University of Hawaii Clinics at Kaka'ako
Honolulu, Hawaii, United States, 96813
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Brigham & Women's Hospital and Harvard Medical School
Boston, Massachusetts, United States, 02115
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Community Research Initiative of New England
Boston, Massachusetts, United States, 02129
MetroWest Medical Center
Framingham, Massachusetts, United States, 01702
The Research Institute
Springfield, Massachusetts, United States, 01105
United States, Michigan
Be Well Medical Center
Berkley, Michigan, United States, 48072
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55404
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Missouri
Kansas City Care Clinic
Kansas City, Missouri, United States, 64111
Southampton Healthcare, Inc.
Saint Louis, Missouri, United States, 63139
United States, New Jersey
Prime Healthcare Services - St Michael's LLC d/b/a Saint Michael's Medical Center
Newark, New Jersey, United States, 07102
United States, New Mexico
Southwest CARE Center
Albuquerque, New Mexico, United States, 87109
Southwest CARE Center
Santa Fe, New Mexico, United States, 87505
United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
Montefiore Medical Center
Bronx, New York, United States, 10467
North Shore University Hospital
Manhasset, New York, United States, 11030
United States, North Carolina
University of North Carolina at Chapel Hill / UNC School of Medicine
Chapel Hill, North Carolina, United States, 27599
Duke University
Durham, North Carolina, United States, 27710
East Carolina University, The Brody School of Medicine
Greenville, North Carolina, United States, 27858
Rosedale Infectious Diseases
Huntersville, North Carolina, United States, 28078
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, South Carolina
Medical University of SC, Division of Infectious Disease
Charleston, South Carolina, United States, 29425
University of South Carolina School of Medicine
Columbia, South Carolina, United States, 29203
United States, Texas
Central Texas Clinical Research
Austin, Texas, United States, 78705
AIDS ARMS Clinic
Dallas, Texas, United States, 75215
North Texas Infectious Diseases Consultants
Dallas, Texas, United States, 75246
Therapeutic Concepts, PA
Houston, Texas, United States, 77004
Gordon E. Crofoot MD PA
Houston, Texas, United States, 77098
Research Access Network
Houston, Texas, United States, 77098
Diagnostic Clinic of Longview - Center for Clinical Research
Longview, Texas, United States, 75605
United States, Washington
Peter Shalit, MD
Seattle, Washington, United States, 98104
Premier Clinical Research
Spokane, Washington, United States, 99204
Austria
Medizinische Universitat Wien, Universitätsklinik fur Dermatologie
Wien, Austria, 1090
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2G3
Canada, British Columbia
Spectrum Health Group
Vancouver, British Columbia, Canada, 6Z 2T1
Canada, Manitoba
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario
Maple Leaf Research
Toronto, Ontario, Canada, M5G 1K2
Canada, Quebec
CHU Bichat
Montréal, Quebec, Canada, H2L 5B1
McGill University
Montréal, Quebec, Canada, H4A 3J1
France
Hopital Saint-Andre
Bordeaux, France, 33075
Hôpital de la Croix Rousse - Maladie Infectieuses et Topicales
Lyon, France, 69004
Hôpital Gui de Chauliac, CHU de Montpellier
Montpellier, France, 34295
CHU de Nice-l Archet
Nice, France, 6202
CHU Bichat
Paris, France, 75018
Hôpital Saint Louis - Hopital Saint Antoine - Maladie Infectieuses et Topicales
Paris, France, 75475
Hopital Saint Antoine - Maladie Infectieuses et Topicales
Paris, France, 75571
AP-HP Hôpital Tenon
Paris, France, 75970
Germany
MIB Dienstleistung GmbH
Berlin, Germany, 10439
Epimed GmbH
Berlin, Germany, 12157
University Hospital Bonn
Bonn, Germany, 53127
Universitatsklinik Koln
Cologne, Germany, 50937
Universitatsklinikum Essen
Essen, Germany, 45122
ICH Study Center Hamburg
Frankfurt am main, Germany, 20146
Universitätsklinikum Frankfurt, Medizinische Klinik
Frankfurt am Main, Germany, 60590
Infektio Research
Frankfurt am main, Germany, 60956
Universitatsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Puerto Rico
Instituto de Investigacion Cientifica del Sur
Ponce, Puerto Rico, 00730
Clinical Research Puerto Rico Inc
San Juan, Puerto Rico, 00909-1711
Hope Clinical Research
San Juan, Puerto Rico, 00909
University of Puerto Rico School of Medicine
San Juan, Puerto Rico, 00935
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03110380     History of Changes
Other Study ID Numbers: GS-US-380-4030
2017-000308-17 ( EudraCT Number )
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents