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Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naïve Adults

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ClinicalTrials.gov Identifier: NCT02607930
Recruitment Status : Completed
First Posted : November 18, 2015
Results First Posted : July 23, 2018
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE November 10, 2015
First Posted Date  ICMJE November 18, 2015
Results First Submitted Date  ICMJE May 2, 2018
Results First Posted Date  ICMJE July 23, 2018
Last Update Posted Date July 28, 2021
Actual Study Start Date  ICMJE November 13, 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 Who Achieved 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
Proportion of participants who achieve HIV-1 RNA < 50 copies/mL as defined by the US FDA snapshot algorithm [ Time Frame: Week 48 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2021)
  • Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 96 ]
    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 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.
  • Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 144 ]
    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 144 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.
  • Percentage of Participants Who Achieved HIV-1 RNA < 20 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 < 20 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.
  • Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 96 ]
    The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 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.
  • Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 144 ]
    The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 144 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 log10 HIV-1 RNA at Week 48 [ Time Frame: Baseline; Week 48 ]
  • Change From Baseline in log10 HIV-1 RNA at Week 96 [ Time Frame: Baseline; Week 96 ]
  • Change From Baseline in log10 HIV-1 RNA at Week 144 [ Time Frame: Baseline; Week 144 ]
  • Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline; Week 48 ]
  • Change From Baseline in CD4+ Cell Count at Week 96 [ Time Frame: Baseline; Week 96 ]
  • Change From Baseline in CD4+ Cell Count at Week 144 [ Time Frame: Baseline; Week 144 ]
  • Percentage Change From Baseline in Hip BMD at Week 48 [ Time Frame: Baseline; Week 48 ]
  • Percentage Change From Baseline in Hip BMD at Week 96 [ Time Frame: Baseline; Week 96 ]
  • Percentage Change From Baseline in Hip BMD at Week 144 [ Time Frame: Baseline; Week 144 ]
  • Percentage Change From Baseline in Spine BMD at Week 48 [ Time Frame: Baseline; Week 48 ]
  • Percentage Change From Baseline in Spine BMD at Week 96 [ Time Frame: Baseline; Week 96 ]
  • Percentage Change From Baseline in Spine BMD at Week 144 [ Time Frame: Baseline; Week 144 ]
  • Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm [ Time Frame: Baseline; open-label Week 48 ]
    The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with non-missing HIV-1 RNA value at that visit.
  • Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm [ Time Frame: Baseline; open-label Week 48 ]
    The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set.
  • Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded and Missing = Failure Algorithm [ Time Frame: Baseline; open-label Week 96 ]
  • Change From Baseline in CD4+ Cell Count at Week 48 Open-Label [ Time Frame: Baseline; open-label Week 48 ]
  • Change From Baseline in CD4+ Cell Count at Week 96 Open-Label [ Time Frame: Baseline; open-label Week 96 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
  • Proportion of participants who achieve HIV-1 RNA < 50 copies/mL as defined by the US FDA snapshot algorithm [ Time Frame: Week 96 ]
  • Proportion of participants who achieve HIV-1 RNA < 20 copies/mL as defined by the US FDA snapshot algorithm [ Time Frame: Weeks 48 and 96 ]
  • Change from baseline in log10 HIV-1 RNA [ Time Frame: Baseline; Weeks 48 and 96 ]
  • Change from baseline in CD4+ cell count [ Time Frame: Baseline; Weeks 48 and 96 ]
  • Percentage change from baseline in hip and spine bone mineral density (BMD) [ Time Frame: Baseline; Weeks 48 and 96 ]
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 Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naïve Adults
Official Title  ICMJE A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Brief Summary The primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus a FDC containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment naive-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 tablets administered orally, once daily, without regard to food
    Other Name: Triumeq®
  • Drug: B/F/TAF
    50/200/25 mg tablets administered orally, once daily, without regard to food
    Other Names:
    • GS-9883/F/TAF
    • Biktarvy®
  • 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 144 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 144 weeks
    Interventions:
    • Drug: ABC/DTG/3TC
    • Drug: B/F/TAF Placebo
  • Experimental: Open-Label (OL) Phase
    After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead 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: June 25, 2018)
631
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2015)
600
Actual Study Completion Date  ICMJE July 2, 2021
Actual Primary Completion Date May 9, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Antiretroviral treatment naïve (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening
  • Plasma HIV-1 RNA levels ≥ 500 copies/mL at screening
  • Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec) according to the Cockcroft-Gault formula
  • Negative screening test for human leukocyte antigen (HLA) -B x 5701 allele provided by Gilead Sciences

Key Exclusion Criteria:

  • An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening (refer to study protocol)
  • Decompensated cirrhosis (e.g, ascites, encephalopathy, or variceal bleeding)
  • Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
  • Females who are pregnant (as confirmed by positive serum pregnancy test)
  • Females who are breastfeeding
  • 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 Belgium,   Canada,   Dominican Republic,   France,   Germany,   Italy,   Puerto Rico,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02607930
Other Study ID Numbers  ICMJE GS-US-380-1489
2015-004024-54 ( 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.gileadclinicaltrials.com/transparency-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.gileadclinicaltrials.com/transparency-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 July 2021

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