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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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02603120
First Posted: November 11, 2015
Last Update Posted: November 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
  Purpose
This study will 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 HIV-1 infected adults.

Condition Intervention 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 Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Proportion 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 ]

Secondary Outcome Measures:
  • Proportion of participants with HIV-1 RNA < 50 copies/mL as defined by the US FDA-defined 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 ]

Enrollment: 567
Actual Study Start Date: November 11, 2015
Estimated Study Completion Date: July 2019
Primary Completion Date: May 9, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: GS-9883/F/TAF
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 Name: GS-9883/F/TAF

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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
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


  Show 94 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02603120     History of Changes
Other Study ID Numbers: GS-US-380-1844
2015-004025-14 ( EudraCT Number )
First Submitted: November 10, 2015
First Posted: November 11, 2015
Last Update Posted: November 21, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Lamivudine
Dolutegravir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
HIV Integrase Inhibitors
Integrase Inhibitors