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

Study Description

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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.

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	631 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 Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults
Actual Study Start Date :	November 13, 2015
Actual Primary Completion Date :	May 9, 2017
Estimated Study Completion Date :	April 2020

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Blinded Phase: B/F/TAF; B/F/TAF + ABC/DTG/3TC placebo for at least 144 weeks	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
Active Comparator: Blinded Phase: ABC/DTG/3TC; ABC/DTG/3TC + B/F/TAF placebo for at least 144 weeks	Drug: ABC/DTG/3TC; 600/50/300 mg tablets administered orally, once daily, without regard to food; Other Name: Triumeq®; 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 tablets administered orally, once daily, without regard to food; Other Names: GS-9883/F/TAF; Biktarvy®

Outcome Measures

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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 ]
12. Hip Bone Mineral Density (BMD) at Baseline [ Time Frame: Baseline ]
13. Percentage Change From Baseline in Hip BMD at Week 48 [ Time Frame: Baseline; Week 48 ]
14. Percentage Change From Baseline in Hip BMD at Week 96 [ Time Frame: Baseline; Week 96 ]
15. Percentage Change From Baseline in Hip BMD at Week 144 [ Time Frame: Baseline; Week 144 ]
16. Spine BMD at Baseline [ Time Frame: Baseline ]
17. Percentage Change From Baseline in Spine BMD at Week 48 [ Time Frame: Baseline; Week 48 ]
18. Percentage Change From Baseline in Spine BMD at Week 96 [ Time Frame: Baseline; Week 96 ]
19. Percentage Change From Baseline in Spine BMD at Week 144 [ Time Frame: Baseline; Week 144 ]

Eligibility Criteria

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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 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*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.

Contacts and Locations

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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

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wohl D, Clarke A, Maggiolo F, Garner W, Laouri M, Martin H, Quirk E. Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir, and Lamivudine. Patient. 2018 Oct;11(5):561-573. doi: 10.1007/s40271-018-0322-8.

Gallant J, Lazzarin A, Mills A, Orkin C, Podzamczer D, Tebas P, Girard PM, Brar I, Daar ES, Wohl D, Rockstroh J, Wei X, Custodio J, White K, Martin H, Cheng A, Quirk E. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2063-2072. doi: 10.1016/S0140-6736(17)32299-7. Epub 2017 Aug 31.

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT02607930 History of Changes
Other Study ID Numbers:	GS-US-380-1489; 2015-004024-54 ( EudraCT Number )
First Posted:	November 18, 2015
Results First Posted:	July 23, 2018
Last Update Posted:	August 24, 2018
Last Verified:	July 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; Lamivudine; Emtricitabine; Dolutegravir; Abacavir; 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