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Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

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ClinicalTrials.gov Identifier: NCT02607956
Recruitment Status : Active, not recruiting
First Posted : November 18, 2015
Results First Posted : June 5, 2018
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
This 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 dolutegravir (DTG) + a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral treatment-naive adults at Week 48.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: DTG Drug: F/TAF Drug: B/F/TAF Drug: DTG Placebo Drug: F/TAF Placebo Drug: B/F/TAF Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 657 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 GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults
Actual Study Start Date : November 11, 2015
Actual Primary Completion Date : May 12, 2017
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Blinded Phase: B/F/TAF
B/F/TAF + DTG placebo + F/TAF placebo for at least 144 weeks
Drug: B/F/TAF
50/200/25 mg FDC tablets administered orally, once daily, without regard to food
Other Names:
  • GS-9883/F/TAF
  • Biktarvy®

Drug: DTG Placebo
Tablets administered orally, once daily, without regard to food

Drug: F/TAF Placebo
Tablets administered orally, once daily, without regard to food

Experimental: Blinded Phase: DTG+F/TAF
DTG+F/TAF + B/F/TAF placebo for at least 144 weeks
Drug: DTG
50 mg tablets administered orally, once daily, without regard to food
Other Name: Tivicay®

Drug: F/TAF
200/25 mg tablets administered orally, once daily, without regard to food
Other Name: Descovy®

Drug: B/F/TAF Placebo
Tablets administered orally, once daily, without regard to food

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 48 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.
Drug: B/F/TAF
50/200/25 mg FDC tablets administered orally, once daily, without regard to food
Other Names:
  • GS-9883/F/TAF
  • Biktarvy®




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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.

  4. 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 ]
  5. 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 ]
  6. Change From Baseline in log10 HIV-1 RNA at Week 48 [ Time Frame: Baseline; Week 48 ]
  7. Change From Baseline in log10 HIV-1 RNA at Week 96 [ Time Frame: Baseline; Week 96 ]
  8. Change From Baseline in log10 HIV-1 RNA at Week 144 [ Time Frame: Baseline; Week 144 ]
  9. Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline; Week 48 ]
  10. Change From Baseline in CD4+ Cell Count at Week 96 [ Time Frame: Baseline; Week 96 ]
  11. Change From Baseline in CD4+ Cell Count at Week 144 [ Time Frame: Baseline; Week 144 ]


Information from the National Library of Medicine

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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:

  • Antiretroviral treatment naive (≤ 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 ≥ 30 mL/min (≥ 0.50 mL/sec) according to the Cockcroft-Gault formula

Key Exclusion Criteria:

  • An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
  • Decompensated cirrhosis (eg, 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

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): NCT02607956


  Show 123 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  Study Documents (Full-Text)

Documents provided by Gilead Sciences:
Study Protocol: Original  [PDF] October 21, 2015
Study Protocol: Amendment 1  [PDF] February 19, 2016
Study Protocol: Amendment 2  [PDF] October 19, 2016
Statistical Analysis Plan  [PDF] May 10, 2017


Publications of Results:
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02607956     History of Changes
Other Study ID Numbers: GS-US-380-1490
2015-003988-10 ( EudraCT Number )
First Posted: November 18, 2015    Key Record Dates
Results First Posted: June 5, 2018
Last Update Posted: June 5, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gilead Sciences:
HIV

Additional relevant MeSH terms:
Tenofovir
Emtricitabine
Dolutegravir
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
HIV Integrase Inhibitors
Integrase Inhibitors