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Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed

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ClinicalTrials.gov Identifier: NCT02603120
Recruitment Status : Completed
First Posted : November 11, 2015
Results First Posted : July 23, 2018
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE November 10, 2015
First Posted Date  ICMJE November 11, 2015
Results First Submitted Date  ICMJE May 1, 2018
Results First Posted Date  ICMJE July 23, 2018
Last Update Posted Date November 12, 2020
Actual Study Start Date  ICMJE November 11, 2015
Actual Primary Completion Date May 9, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2018)
Percentage 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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
Proportion of participants with virologic failure (HIV-1 RNA ≥ 50 copies/mL) as defined by the modified US FDA snapshot algorithm [ Time Frame: Week 48 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2018)
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL 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.
  • Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline; Week 48 ]
  • Spine Bone Mineral Density (BMD) at Baseline [ Time Frame: Baseline ]
  • Percentage Change From Baseline in Spine BMD at Week 48 [ Time Frame: Baseline; Week 48 ]
  • Hip Bone Mineral Density at Baseline [ Time Frame: Baseline ]
  • Percentage Change From Baseline in Hip BMD at Week 48 [ Time Frame: Baseline; Week 48 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
  • Proportion of participants with HIV-1 RNA < 50 copies/mL as defined by the US FDA snapshot algorithm [ Time Frame: Week 48 ]
  • Change from baseline in CD4+ cell count at Week 48 [ Time Frame: Baseline and Week 48 ]
  • Percentage change from baseline in hip and spine bone mineral density (BMD) at Week 48 [ Time Frame: Baseline and Week 48 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed
Official Title  ICMJE A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed
Brief Summary The primary objective of this study is to evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus- 1 (HIV-1) infected adults.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE HIV-1 Infection
Intervention  ICMJE
  • Drug: ABC/DTG/3TC
    600/50/300 mg FDC tablets administered orally once daily without regard to food
    Other Name: Triumeq®
  • Drug: B/F/TAF
    50/200/25 mg FDC tablets administered orally once daily without regard to food
    Other Names:
    • Bictegravir (previously referred to as GS-9883)/Emtricitabine/Tenofovir Alafenamide
    • Biktarvy® [BVY]
  • Drug: ABC/DTG/3TC Placebo
    Tablets administered orally once daily without regard to food
  • Drug: B/F/TAF Placebo
    Tablets administered orally once daily without regard to food
Study Arms  ICMJE
  • Experimental: Blinded Phase: B/F/TAF
    B/F/TAF + ABC/DTG/3TC placebo for at least 48 weeks
    Interventions:
    • Drug: B/F/TAF
    • Drug: ABC/DTG/3TC Placebo
  • Active Comparator: Blinded Phase: ABC/DTG/3TC
    ABC/DTG/3TC + B/F/TAF placebo for at least 48 weeks
    Interventions:
    • Drug: ABC/DTG/3TC
    • Drug: B/F/TAF Placebo
  • Experimental: Open-Label Phase
    At the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF is demonstrated following review of unblinded data, participants in a country where B/F/TAF FDC is not available will be given the option to receive B/F/TAF FDC in an open-label extension phase for up to 96 weeks, or until the product becomes accessible to subjects through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever occurs first.
    Intervention: Drug: B/F/TAF
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2017)
567
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2015)
520
Actual Study Completion Date  ICMJE October 23, 2019
Actual Primary Completion Date May 9, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec).
  • Currently receiving an antiretroviral regimen of DTG + ABC/3TC, or ABC/DTG/3TC FDC for ≥ 3 months prior to the screening visit.
  • HIV ribonucleic acid (RNA) < 50 copies/mL at the screening visit.
  • Currently on a stable regimen for ≥ 3 months preceding the screening visit with documented plasma HIV-1 RNA < 50 copies/mL for ≥ 3 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
  • Have no documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), DTG, ABC or 3TC.

Key Exclusion Criteria:

  • Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance.
  • Active tuberculosis infection.
  • Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
  • Females who are pregnant.
  • Females who are breastfeeding.
  • Acute hepatitis in the 30 days prior to study entry.
  • Chronic Hepatitis B Virus (HBV) infection.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   France,   Germany,   Italy,   Puerto Rico,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02603120
Other Study ID Numbers  ICMJE GS-US-380-1844
2015-004025-14 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date October 2020

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