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

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT03110380
Collaborator
(none)
567
94
4
44
6
0.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
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 :
Jun 12, 2017
Actual Primary Completion Date :
Dec 4, 2018
Actual Study Completion Date :
Feb 10, 2021

Arms and Interventions

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:
  • 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 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:
  • GS-9883/F/TAF
  • Biktarvy®
  • 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:
  • GS-9883/F/TAF
  • Biktarvy®
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. Change From Baseline in CD4+ Cell Count at Week 48 [Baseline; Week 48]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT03110380
    Other Study ID Numbers:
    • GS-US-380-4030
    • 2017-000308-17
    First Posted:
    Apr 12, 2017
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled at study sites in North America and Europe. The first participant was screened on 12 June 2017. The last study visit occurred on 10 Feb 2021.
    Pre-assignment Detail 633 participants were screened.
    Arm/Group Title B/F/TAF DTG + F/TAF B/F/TAF From B/F/TAF B/F/TAF From DTG + F/TAF
    Arm/Group Description Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet + dolutegravir (DTG) placebo tablet + emtricitabine/tenofovir alafenamide (F/TAF) placebo tablet administered orally once daily without regard to food for at least 48 weeks. DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks. 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. 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.
    Period Title: Double-Blind Treatment Phase
    STARTED 284 283 0 0
    Safety Analysis Set 284 281 0 0
    COMPLETED 263 253 0 0
    NOT COMPLETED 21 30 0 0
    Period Title: Double-Blind Treatment Phase
    STARTED 0 0 125 116
    COMPLETED 0 0 121 113
    NOT COMPLETED 0 0 4 3

    Baseline Characteristics

    Arm/Group Title B/F/TAF DTG + F/TAF Total
    Arm/Group Description B/F/TAF (50/200/25 mg) FDC tablet + DTG placebo tablet + F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks. DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks. Total of all reporting groups
    Overall Participants 284 281 565
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    50
    (11.3)
    49
    (11.3)
    50
    (11.3)
    Sex: Female, Male (Count of Participants)
    Female
    39
    13.7%
    41
    14.6%
    80
    14.2%
    Male
    245
    86.3%
    240
    85.4%
    485
    85.8%
    Race/Ethnicity, Customized (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    1
    0.4%
    1
    0.2%
    Asian
    3
    1.1%
    3
    1.1%
    6
    1.1%
    Black
    68
    23.9%
    61
    21.7%
    129
    22.8%
    Native Hawaiian or Pacific Islander
    2
    0.7%
    1
    0.4%
    3
    0.5%
    White
    200
    70.4%
    199
    70.8%
    399
    70.6%
    Other
    9
    3.2%
    13
    4.6%
    22
    3.9%
    Not Permitted
    2
    0.7%
    3
    1.1%
    5
    0.9%
    Race/Ethnicity, Customized (Count of Participants)
    Hispanic or Latino
    61
    21.5%
    49
    17.4%
    110
    19.5%
    Not Hispanic or Latino
    220
    77.5%
    229
    81.5%
    449
    79.5%
    Not Permitted
    3
    1.1%
    3
    1.1%
    6
    1.1%
    Region of Enrollment (Count of Participants)
    Canada
    24
    8.5%
    25
    8.9%
    49
    8.7%
    Austria
    2
    0.7%
    1
    0.4%
    3
    0.5%
    United States
    197
    69.4%
    202
    71.9%
    399
    70.6%
    France
    12
    4.2%
    14
    5%
    26
    4.6%
    Germany
    30
    10.6%
    26
    9.3%
    56
    9.9%
    Puerto Rico
    19
    6.7%
    13
    4.6%
    32
    5.7%
    HIV-1 RNA Category (Count of Participants)
    < 50 copies/mL
    276
    97.2%
    275
    97.9%
    551
    97.5%
    ≥ 50 copies/mL
    8
    2.8%
    6
    2.1%
    14
    2.5%
    CD4 Cell Count (Cells/μL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Cells/μL]
    714
    (309.1)
    658
    (294.7)
    686
    (303.1)
    CD4 Cell Count Category (Count of Participants)
    < 50 Cells/ μL
    0
    0%
    1
    0.4%
    1
    0.2%
    ≥ 50 to < 200 Cells/μL
    6
    2.1%
    6
    2.1%
    12
    2.1%
    ≥ 200 to < 350 Cells/μL
    18
    6.3%
    34
    12.1%
    52
    9.2%
    ≥ 350 to < 500 Cells/μL
    53
    18.7%
    44
    15.7%
    97
    17.2%
    ≥ 500 Cells/ μL
    207
    72.9%
    196
    69.8%
    403
    71.3%

    Outcome Measures

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

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.
    Arm/Group Title B/F/TAF DTG + F/TAF
    Arm/Group Description B/F/TAF (50/200/25 mg) FDC tablet + DTG placebo tablet + F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks. DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.
    Measure Participants 284 281
    Number [percentage of participants]
    0.4
    0.1%
    1.1
    0.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
    Comments The null hypothesis was that the B/F/TAF group is at least 4% higher than the DTG + F/TAF group with respect to the percentage of participants with HIV-1 RNA ≥ 50 copies/mL as determined by the US FDA-defined snapshot algorithm at Week 48; the alternative hypothesis was that the B/F/TAF group is less than 4% higher than the DTG + F/TAF group with respect to the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48.
    Type of Statistical Test Non-Inferiority
    Comments A sample size of 260 participants per treatment group would provide at least 90% power to detect a non-inferiority margin of 4% in difference in percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 between the two treatment groups. This was based on the assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 (based on Gilead Genvoya and Stribild studies) and that the significance level of the test is at a one-sided 0.025 level.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95.001%
    -2.8 to 1.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments The differences in percentages of participants between treatment groups and their 95.001% confidence intervals (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.37
    Comments
    Method Fisher Exact
    Comments
    2. Secondary Outcome
    Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
    Description 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.
    Time Frame Week 48

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set were analyzed.
    Arm/Group Title B/F/TAF DTG + F/TAF
    Arm/Group Description B/F/TAF (50/200/25 mg) FDC tablet + DTG placebo tablet + F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks. DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.
    Measure Participants 284 281
    Number [percentage of participants]
    93.3
    32.9%
    91.1
    32.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
    Comments
    Type of Statistical Test Non-Inferiority
    Comments It would be concluded that B/F/TAF is noninferior to DTG+F/TAF if the lower bound of the 2-sided 95.001% CI of the difference between treatment groups (B/F/TAF group -DTG+F/TAF group) in the percentage of participants with HIV-1 RNA < 50 copies/mL is greater than -10%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 2.2
    Confidence Interval (2-Sided) 95.001%
    -2.3 to 6.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments The differences in percentages of participants between treatment groups and their 95.001% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.
    3. Secondary Outcome
    Title Change From Baseline in CD4+ Cell Count at Week 48
    Description
    Time Frame Baseline; Week 48

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title B/F/TAF DTG + F/TAF
    Arm/Group Description B/F/TAF (50/200/25 mg) FDC tablet + DTG placebo tablet + F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks. DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.
    Measure Participants 262 256
    Mean (Standard Deviation) [cells/µL]
    18
    (179.1)
    36
    (152.6)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.23
    Comments
    Method ANOVA
    Comments P-value, difference in least squares means (LSM), and its 95% CI were from ANOVA model with treatment group as a fixed effect in the model.
    Method of Estimation Estimation Parameter Difference in LSM
    Estimated Value -18
    Confidence Interval (2-Sided) 95%
    -46 to 11
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks
    Adverse Event Reporting Description Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
    Arm/Group Title Double-Blind Treatment Phase B/F/TAF Double-Blind Treatment Phase DTG + F/TAF Open-label Extension Phase B/F/TAF From B/F/TAF Open-label Extension Phase B/F/TAF From DTG + F/TAF
    Arm/Group Description B/F/TAF (50/200/25 mg) FDC tablet + DTG placebo tablet + F/TAF placebo tablet administered orally once daily without regard to food for atleast 48 weeks. DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for atleast 48 weeks. 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. 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.
    All Cause Mortality
    Double-Blind Treatment Phase B/F/TAF Double-Blind Treatment Phase DTG + F/TAF Open-label Extension Phase B/F/TAF From B/F/TAF Open-label Extension Phase B/F/TAF From DTG + F/TAF
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/284 (1.1%) 2/283 (0.7%) 0/125 (0%) 0/117 (0%)
    Serious Adverse Events
    Double-Blind Treatment Phase B/F/TAF Double-Blind Treatment Phase DTG + F/TAF Open-label Extension Phase B/F/TAF From B/F/TAF Open-label Extension Phase B/F/TAF From DTG + F/TAF
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 36/284 (12.7%) 27/281 (9.6%) 12/125 (9.6%) 11/116 (9.5%)
    Blood and lymphatic system disorders
    Lymphocytic infiltration 0/284 (0%) 0/281 (0%) 0/125 (0%) 1/116 (0.9%)
    Cardiac disorders
    Acute myocardial infarction 0/284 (0%) 0/281 (0%) 2/125 (1.6%) 0/116 (0%)
    Angina pectoris 0/284 (0%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Cardiac failure congestive 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Cardio-respiratory arrest 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Coronary artery disease 2/284 (0.7%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Myocardial infarction 0/284 (0%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Sinus tachycardia 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Ventricular tachycardia 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Gastrointestinal disorders
    Abdominal pain 0/284 (0%) 1/281 (0.4%) 0/125 (0%) 1/116 (0.9%)
    Colitis 0/284 (0%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Inguinal hernia 0/284 (0%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Large intestine perforation 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Obstructive pancreatitis 0/284 (0%) 0/281 (0%) 1/125 (0.8%) 0/116 (0%)
    Vomiting 0/284 (0%) 1/281 (0.4%) 1/125 (0.8%) 0/116 (0%)
    General disorders
    Chest pain 1/284 (0.4%) 0/281 (0%) 1/125 (0.8%) 1/116 (0.9%)
    Death 0/284 (0%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Non-cardiac chest pain 0/284 (0%) 0/281 (0%) 0/125 (0%) 1/116 (0.9%)
    Hepatobiliary disorders
    Biliary dyskinesia 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Cholangitis acute 0/284 (0%) 0/281 (0%) 0/125 (0%) 1/116 (0.9%)
    Cholecystitis 1/284 (0.4%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Cholecystitis acute 0/284 (0%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Immune system disorders
    Anti-neutrophil cytoplasmic antibody positive vasculitis 0/284 (0%) 0/281 (0%) 0/125 (0%) 1/116 (0.9%)
    Infections and infestations
    Appendicitis 0/284 (0%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Bronchitis 0/284 (0%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Cellulitis 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Cellulitis orbital 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Colonic abscess 0/284 (0%) 0/281 (0%) 0/125 (0%) 1/116 (0.9%)
    Covid-19 pneumonia 0/284 (0%) 0/281 (0%) 1/125 (0.8%) 0/116 (0%)
    Device related infection 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Diarrhoea infectious 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Diverticulitis 2/284 (0.7%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Epididymitis 0/284 (0%) 0/281 (0%) 0/125 (0%) 1/116 (0.9%)
    Gastroenteritis 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Meningitis 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Perirectal abscess 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Pneumonia 1/284 (0.4%) 2/281 (0.7%) 0/125 (0%) 2/116 (1.7%)
    Post procedural infection 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Pyelonephritis 1/284 (0.4%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Sepsis 0/284 (0%) 0/281 (0%) 0/125 (0%) 1/116 (0.9%)
    Viral upper respiratory tract infection 0/284 (0%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Wound infection 0/284 (0%) 0/281 (0%) 1/125 (0.8%) 0/116 (0%)
    Injury, poisoning and procedural complications
    Ankle fracture 0/284 (0%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Clavicle fracture 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Concussion 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Facial bones fracture 0/284 (0%) 0/281 (0%) 1/125 (0.8%) 0/116 (0%)
    Foreign body in gastrointestinal tract 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Hip fracture 0/284 (0%) 0/281 (0%) 0/125 (0%) 1/116 (0.9%)
    Ligament rupture 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Lisfranc fracture 0/284 (0%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Overdose 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Rib fracture 0/284 (0%) 0/281 (0%) 1/125 (0.8%) 0/116 (0%)
    Subdural haematoma 0/284 (0%) 0/281 (0%) 1/125 (0.8%) 0/116 (0%)
    Subdural haemorrhage 0/284 (0%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Tendon rupture 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Investigations
    Blood glucose increased 0/284 (0%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Lipase increased 0/284 (0%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Liver function test increased 0/284 (0%) 0/281 (0%) 0/125 (0%) 1/116 (0.9%)
    Transaminases increased 0/284 (0%) 0/281 (0%) 1/125 (0.8%) 0/116 (0%)
    Metabolism and nutrition disorders
    Dehydration 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Hyperglycaemia 0/284 (0%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Hypokalaemia 0/284 (0%) 0/281 (0%) 1/125 (0.8%) 0/116 (0%)
    Musculoskeletal and connective tissue disorders
    Lumbar spinal stenosis 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Myalgia 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Osteonecrosis 0/284 (0%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Osteoporosis 0/284 (0%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Rhabdomyolysis 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Spondylolisthesis 0/284 (0%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm malignant 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Metastases to spine 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Yolk sac tumour site unspecified 0/284 (0%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Nervous system disorders
    Cerebrovascular accident 0/284 (0%) 0/281 (0%) 1/125 (0.8%) 1/116 (0.9%)
    Sciatica 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Seizure 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Vertebral artery dissection 0/284 (0%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Psychiatric disorders
    Alcohol withdrawal syndrome 0/284 (0%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Drug abuse 2/284 (0.7%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Psychotic disorder 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Rebound psychosis 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Renal and urinary disorders
    Acute kidney injury 0/284 (0%) 0/281 (0%) 0/125 (0%) 1/116 (0.9%)
    Nephrolithiasis 0/284 (0%) 0/281 (0%) 1/125 (0.8%) 0/116 (0%)
    Urinary tract obstruction 0/284 (0%) 0/281 (0%) 1/125 (0.8%) 0/116 (0%)
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Chronic obstructive pulmonary disease 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Dyspnoea 2/284 (0.7%) 1/281 (0.4%) 0/125 (0%) 0/116 (0%)
    Pneumonia aspiration 0/284 (0%) 0/281 (0%) 0/125 (0%) 1/116 (0.9%)
    Pneumonitis 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Pneumothorax 1/284 (0.4%) 0/281 (0%) 0/125 (0%) 0/116 (0%)
    Skin and subcutaneous tissue disorders
    Purpura 0/284 (0%) 0/281 (0%) 0/125 (0%) 1/116 (0.9%)
    Other (Not Including Serious) Adverse Events
    Double-Blind Treatment Phase B/F/TAF Double-Blind Treatment Phase DTG + F/TAF Open-label Extension Phase B/F/TAF From B/F/TAF Open-label Extension Phase B/F/TAF From DTG + F/TAF
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 181/284 (63.7%) 170/281 (60.5%) 30/125 (24%) 33/116 (28.4%)
    Gastrointestinal disorders
    Diarrhoea 26/284 (9.2%) 35/281 (12.5%) 4/125 (3.2%) 7/116 (6%)
    General disorders
    Fatigue 22/284 (7.7%) 9/281 (3.2%) 1/125 (0.8%) 7/116 (6%)
    Infections and infestations
    Bronchitis 18/284 (6.3%) 14/281 (5%) 4/125 (3.2%) 5/116 (4.3%)
    Influenza 19/284 (6.7%) 17/281 (6%) 2/125 (1.6%) 1/116 (0.9%)
    Nasopharyngitis 44/284 (15.5%) 32/281 (11.4%) 3/125 (2.4%) 1/116 (0.9%)
    Sinusitis 16/284 (5.6%) 11/281 (3.9%) 1/125 (0.8%) 4/116 (3.4%)
    Upper respiratory tract infection 33/284 (11.6%) 40/281 (14.2%) 9/125 (7.2%) 10/116 (8.6%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 24/284 (8.5%) 21/281 (7.5%) 4/125 (3.2%) 4/116 (3.4%)
    Back pain 20/284 (7%) 15/281 (5.3%) 2/125 (1.6%) 3/116 (2.6%)
    Pain in extremity 15/284 (5.3%) 15/281 (5.3%) 1/125 (0.8%) 4/116 (3.4%)
    Nervous system disorders
    Headache 16/284 (5.6%) 23/281 (8.2%) 1/125 (0.8%) 4/116 (3.4%)
    Psychiatric disorders
    Insomnia 19/284 (6.7%) 14/281 (5%) 1/125 (0.8%) 3/116 (2.6%)
    Respiratory, thoracic and mediastinal disorders
    Cough 11/284 (3.9%) 16/281 (5.7%) 4/125 (3.2%) 2/116 (1.7%)
    Skin and subcutaneous tissue disorders
    Rash 9/284 (3.2%) 15/281 (5.3%) 0/125 (0%) 2/116 (1.7%)
    Vascular disorders
    Hypertension 15/284 (5.3%) 11/281 (3.9%) 3/125 (2.4%) 0/116 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years

    Results Point of Contact

    Name/Title Gilead Clinical Study Information Center
    Organization Gilead Sciences
    Phone 1-833-445-3230 (GILEAD-0)
    Email GileadClinicalTrials@gilead.com
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT03110380
    Other Study ID Numbers:
    • GS-US-380-4030
    • 2017-000308-17
    First Posted:
    Apr 12, 2017
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Dec 1, 2021