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

December 14, 2021 updated by: Gilead Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

567

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1090
        • Medizinische Universitat Wien, Universitatsklinik fur Dermatologie
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2G3
        • Kaye Edmonton Clinic
    • British Columbia
      • Vancouver, British Columbia, Canada, 6Z 2T1
        • Spectrum Health Clinic
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg
    • Ontario
      • Toronto, Ontario, Canada, M5G 1K2
        • Maple Leaf Research / Maple Leaf Medical Clinic
    • Quebec
      • Montréal, Quebec, Canada, H2L 5B1
        • Clinique de médecine Urbaine du Quartier Latin
      • Montréal, Quebec, Canada, H4A 3J1
        • Chronical Viral Illness Service/McGill University Health Care (MUHC)
  • France
      • Bordeaux, France, 33075
        • Hôpital Saint-André
      • Lyon, France, 69004
        • Hôpital Croix-Rousse
      • Montpellier, France, 34295
        • Hôpital Gui de Chauliac, CHU de Montpellier
      • Nice, France, 06202
        • CHU de Nice-l'Archet
      • Paris, France, 75475
        • Hopital Saint-Louis
      • Paris, France, 75571
        • Hopital Saint-Antoine
      • Paris, France, 75018
        • CHU Bichat
      • Paris, France, 75020
        • AP-HP Hôpital Tenon
  • Germany
      • Berlin, Germany, 10439
        • zibp Zentrum für Infektiologie Berlin Prenzlauer Berg
      • Berlin, Germany, 12157
        • EPIMED Gesellschaft fur epidemiologische und klinische Forschung in der Medizin mbH
      • Bonn, Germany, 53127
        • Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Klinisches Studienzentrum Immunologie
      • Cologne, Germany, 50937
        • Universitätsklinikum Köln - Klinik I fur Innere Medizin - Klinisches Studienzentrum fur Infektiologie I
      • Essen, Germany, 45122
        • Universitätsklinikum Essen - Klinik fur Dermatologie und Venerologie - HPSTD Ambulanz
      • Frankfurt am Main, Germany, 60590
        • Universitätsklinikum Frankfurt, Medizinische Klinik II, Schwerpunkt Infektiologie, Haus 68
      • Frankfurt am Main, Germany, 60596
        • Infektiologikum Frankfurt
      • Hamburg, Germany, 20146
        • ICH Study Center GmbH & Co. KG
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg- Eppendorf - Ambulanzzentrum des Universitatsklinikums Eppendorf GmbH - Bereich Infektiologie
  • Puerto Rico
      • Ponce, Puerto Rico, 00730
        • Instituto De Investigacion Cientifica Del Sur
      • San Juan, Puerto Rico, 00909
        • Hope Clinical Research
      • San Juan, Puerto Rico, 00935
        • Proyecto ACTU
      • San Juan, Puerto Rico, 909
        • Clinical Research Puerto Rico
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Spectrum Medical Group
    • California
      • Los Angeles, California, United States, 90069
        • Mills Clinical Research
      • Los Angeles, California, United States, 90036
        • Ruane Clinical Research Group Inc.
      • Oakland, California, United States, 94602
        • Highland Hospital - Alameda Health System
      • Sacramento, California, United States, 95825
        • Kaiser Permanente
      • Sacramento, California, United States, 95814
        • Cares Community Health
      • San Francisco, California, United States, 94118
        • Kaiser Permanente
      • San Francisco, California, United States, 94110
        • Hepatitis/HIV Clinical Trials Group (HHCTG)
      • San Leandro, California, United States, 94577
        • Kaiser Permanente, Department of Infectious Diseases
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver, University of Colorado Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
        • Dupont Circle Physician's Group
      • Washington, District of Columbia, United States, 20037
        • The GW Medical Faculty Associates
      • Washington, District of Columbia, United States, 20005
        • Whitman-Walker Institute
      • Washington, District of Columbia, United States, 20017
        • Providence Hospital Center for Infectious Diseases
    • Florida
      • DeLand, Florida, United States, 32720
        • Midland Florida Clinical Research Center, LLC
      • Fort Lauderdale, Florida, United States, 33308
        • Therafirst Medical Center
      • Fort Lauderdale, Florida, United States, 33316
        • Gary J. Richmond, M.D., P.A.
      • Fort Pierce, Florida, United States, 34982
        • Midway Immunology and Research Center
      • Miami, Florida, United States, 33136
        • University of Miami Divison of Infectious Diseases Clinical Research Unit
      • Miami Beach, Florida, United States, 33140
        • AIDS Healthcare Foundation - South Beach
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center
      • Pensacola, Florida, United States, 32503
        • AHF-Pensacola
      • Tampa, Florida, United States, 33614
        • Infectious Disease Research Institute Inc
      • Tampa, Florida, United States, 33614
        • St. Joseph's Hospital Comprehensive Research Institute
      • Vero Beach, Florida, United States, 32960
        • AIDS Research and Treatment Center of the Treasure Coast
      • West Palm Beach, Florida, United States, 33407
        • Triple O Research Institute, P.A.
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory Hospital Midtown Infectious Disease Clinic
      • Atlanta, Georgia, United States, 30312
        • AIDS Research Consortium of Atlanta
      • Augusta, Georgia, United States, 30912
        • AU Medical Center
      • Decatur, Georgia, United States, 30033
        • Infectious Disease Specialists of Atlanta
      • Macon, Georgia, United States, 31201
        • Mercer University, Department of Internal Medicine
      • Savannah, Georgia, United States, 31401
        • Chatham County Health Department
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • John A. Burns School of Medicine, University of Hawaii Clinics at Kaka'ako
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville 550 Clinic
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Boston, Massachusetts, United States, 02129
        • Community Research Initiative of New England
      • Framingham, Massachusetts, United States, 01702
        • Metro West Medical Center
      • Springfield, Massachusetts, United States, 01105
        • Claudia T Martorell, MD., LLC d/b/a The Research Institute
    • Michigan
      • Berkley, Michigan, United States, 48072
        • Be Well Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital part of Allina Health
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center, Positive Care Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Kansas City Care Clinic
      • Saint Louis, Missouri, United States, 63139
        • Southampton Healthcare, Inc.
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Prime Healthcare Services - St. Michael's LLC d/b/a Saint Michael's Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Southwest CARE Center
      • Santa Fe, New Mexico, United States, 87505
        • Southwest CARE Center
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Bronx, New York, United States, 10461
        • Jacobi Medical Center
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital/Division of Infectious Diseases
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University Heath System
      • Greenville, North Carolina, United States, 27834
        • East Carolina University (ECU), The Brody School of Medicine, Adult Specialty Care
      • Huntersville, North Carolina, United States, 28078
        • Rosedale Infectious Diseases
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina (MUSC)
      • Columbia, South Carolina, United States, 29203
        • Palmetto Health Richland (Regulatory and Study Supply Shipping)
    • Texas
      • Austin, Texas, United States, 78705
        • Central Texas Clinical Research
      • Dallas, Texas, United States, 75246
        • North Texas Infectious Diseases Consultants, P.A.
      • Dallas, Texas, United States, 75208
        • AIDS Arms Inc/ Trinity Health and Wellness Center
      • Houston, Texas, United States, 77098
        • The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA)
      • Houston, Texas, United States, 77004
        • Therapeutic Concepts, PA
      • Houston, Texas, United States, 77098
        • Research Access Network
      • Longview, Texas, United States, 75605
        • DCOL Center for Clinical Research
    • Washington
      • Seattle, Washington, United States, 98104
        • Peter Shalit, M.D.
      • Spokane, Washington, United States, 99204
        • MultiCare Rockwood HIV Critical Care Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: B/F/TAF
50/200/25 mg FDC tablet(s) administered orally once daily
Other Names:
  • Biktarvy®
  • GS-9883/F/TAF
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 50 mg tablet + F/TAF FDC tablet + B/F/TAF placebo tablet administered without regard to food for at least 48 weeks.
Drug: F/TAF
200/25 mg FDC tablet(s) administered orally once daily
Other Names:
  • Descovy®
Drug: DTG
50 mg tablet(s) administered orally once daily
Other Names:
  • Tivicay®
Drug: B/F/TAF Placebo
Tablet(s) administered orally once daily
Experimental: 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.
Drug: B/F/TAF
50/200/25 mg FDC tablet(s) administered orally once daily
Other Names:
  • Biktarvy®
  • GS-9883/F/TAF
Experimental: 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.
Drug: B/F/TAF
50/200/25 mg FDC tablet(s) administered orally once daily
Other Names:
  • Biktarvy®
  • GS-9883/F/TAF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
Time Frame: 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.
Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in CD4+ Cell Count at Week 48
Time Frame: Baseline; Week 48
Baseline; Week 48
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
Time Frame: 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.
Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2017

Primary Completion (Actual)

December 4, 2018

Study Completion (Actual)

February 10, 2021

Study Registration Dates

First Submitted

April 7, 2017

First Submitted That Met QC Criteria

April 7, 2017

First Posted (Actual)

April 12, 2017

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

December 14, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-380-4030
  • 2017-000308-17 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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