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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

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ClinicalTrials.gov Identifier: NCT03110380
Recruitment Status : Completed
First Posted : April 12, 2017
Results First Posted : November 20, 2019
Last Update Posted : January 11, 2022
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 /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
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

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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
Actual Primary Completion Date : December 4, 2018
Actual Study Completion Date : February 10, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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 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

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®




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 [ 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.


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 [ 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.

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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.


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


Locations
Show Show 94 study locations
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
  Study Documents (Full-Text)

Documents provided by Gilead Sciences:
Study Protocol  [PDF] June 28, 2018
Statistical Analysis Plan  [PDF] April 30, 2021

Publications of Results:
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03110380    
Other Study ID Numbers: GS-US-380-4030
2017-000308-17 ( EudraCT Number )
First Posted: April 12, 2017    Key Record Dates
Results First Posted: November 20, 2019
Last Update Posted: January 11, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dolutegravir
Emtricitabine tenofovir alafenamide
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors