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Trial record 1 of 4 for:    Emtricitabine/Tenofovir Alafenamide | Recruiting Studies | Phase 3 | Industry
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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

This study is currently recruiting participants.
Verified November 2017 by Gilead Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT03110380
First Posted: April 12, 2017
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
April 7, 2017
April 12, 2017
November 17, 2017
June 12, 2017
February 2019   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT03110380 on ClinicalTrials.gov Archive Site
  • Proportion of participants with HIV-1 RNA < 50 copies/mL as defined by the US FDA-defined snapshot algorithm [ Time Frame: Week 48 ]
  • Change from Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Week 48 ]
Same as current
Not Provided
Not Provided
 
Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Adults Who Are Virologically Suppressed
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 (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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
HIV-1-infection
  • Drug: B/F/TAF
    50/200/25 mg FDC tablet(s) administered orally once daily
    Other Name: GS-9883/F/TAF
  • 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: DTG Placebo
    Tablet(s) administered orally once daily
  • Drug: F/TAF Placebo
    Tablet(s) administered orally once daily
  • Drug: B/F/TAF Placebo
    Tablet(s) administered orally once daily
  • Experimental: B/F/TAF
    B/F/TAF + DTG placebo + F/TAF placebo for 48 Weeks
    Interventions:
    • Drug: B/F/TAF
    • Drug: DTG Placebo
    • Drug: F/TAF Placebo
  • Active Comparator: DTG + F/TAF
    DTG + F/TAF + B/F/TAF placebo for 48 Weeks
    Interventions:
    • Drug: F/TAF
    • Drug: DTG
    • Drug: B/F/TAF Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
520
March 2021
February 2019   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Gilead Study Team 1-833-GILEAD-0(1-833-445-3230) GS-US-380-4030@gilead.com
Canada,   France,   Germany,   Puerto Rico,   United States
 
 
NCT03110380
GS-US-380-4030
2017-000308-17 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Gilead Study Director Gilead Sciences
Gilead Sciences
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP