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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

Study Description
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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.

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 : 567 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 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
Actual Study Start Date : November 11, 2015
Actual Primary Completion Date : May 9, 2017
Actual Study Completion Date : October 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Lamivudine

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 48 weeks
 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
Active Comparator: Blinded Phase: ABC/DTG/3TC
ABC/DTG/3TC + B/F/TAF placebo for at least 48 weeks
 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 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 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.
 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]


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline; Week 48 ]
  3. Spine Bone Mineral Density (BMD) at Baseline [ Time Frame: Baseline ]
  4. Percentage Change From Baseline in Spine BMD at Week 48 [ Time Frame: Baseline; Week 48 ]
  5. Hip Bone Mineral Density at Baseline [ Time Frame: Baseline ]
  6. Percentage Change From Baseline in Hip BMD at Week 48 [ Time Frame: Baseline; Week 48 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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.

Contacts and Locations
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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): NCT02603120


Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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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 2  [PDF] October 19, 2016
Study Protocol: Amendment 1  [PDF] February 19, 2016
Statistical Analysis Plan  [PDF] May 8, 2017

More Information
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Publications of Results:

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

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02603120    
Other Study ID Numbers: GS-US-380-1844
2015-004025-14 ( EudraCT Number )
First Posted: November 11, 2015    Key Record Dates
Results First Posted: July 23, 2018
Last Update Posted: November 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
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
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tenofovir
Emtricitabine
Lamivudine
Emtricitabine tenofovir alafenamide
Triumeq
Antiviral Agents
Anti-Infective Agents
 Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents