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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 : December 21, 2017
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 (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
U.S. FDA Resources

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 Name: 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 + 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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


  Show 94 Study Locations
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: December 21, 2017
Last Verified: December 2017

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