Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis
NCT ID: NCT02600819
Last Updated: 2020-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
55 participants
INTERVENTIONAL
2015-12-14
2019-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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E/C/F/TAF
Participants will switch their current antiretroviral regimen to E/C/F/TAF and receive treatment for 96 weeks. After Week 96, participants in the United States (US) who wish to participate in the open-label (OL) rollover extension will continue to take E/C/F/TAF FDC until the End of E/C/F/TAF Visit.
E/C/F/TAF
150/150/200/10 mg FDC tablets administered orally once daily
Open-Label Rollover Extension B/F/TAF
At Week 96 or the End of E/C/F/TAF Visit (whichever occurs last), participants will be given the option to receive open-label bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for at least 48 weeks.
B/F/TAF
50/200/25 mg FDC tablets administered orally once daily
Interventions
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E/C/F/TAF
150/150/200/10 mg FDC tablets administered orally once daily
B/F/TAF
50/200/25 mg FDC tablets administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Plasma HIV-1 ribonucleic acid (RNA) concentrations \< 50 copies/mL for ≥ 6 months preceding the screening visit and have HIV-1 RNA \< 50 copies/mL at screening
* No documented history of HIV-1 resistance to elvitegravir (EVG), emtricitabine (FTC), lamivudine (3TC) or tenofovir (TFV) and no history of switching off EVG, FTC, 3TC or TFV due to concern for resistance
* Cluster determinant 4 (CD4+) T cell count ≥ 200 cells/μL
* ESRD with estimated glomerular filtration rate (eGFR) \< 15 mL/min by Cockcroft-Gault formula for creatinine clearance
* On chronic HD for ≥ 6 months prior to screening
* Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm\^3; platelets ≥ 50,000/mm\^3; hemoglobin ≥ 8.5 g/dL)
Exclusion Criteria
* Any clinical history, condition, or test result that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements
* Administration of other investigational agents (unless approved by Gilead Sciences). Participation in any other clinical trial, including observational trials, without prior approval from the sponsor is prohibited while participating in this trial.
* History or presence of allergy or intolerance to the study drugs or their components
* A new acquired immunodeficiency syndrome (AIDS)-defining condition (excluding CD4+ T cell count and percentage criteria) diagnosed within the 30 days prior to screening, with the exception of oropharyngeal candidiasis
* Received solid organ or bone marrow transplant
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Peter J Ruane MD Inc
Los Angeles, California, United States
University of California Davis
Sacramento, California, United States
Midway Immunology & Research Center, LLC
Ft. Pierce, Florida, United States
Infectious Disease Consultants, M.D., P.A. d/b/a Orlando Immunology Center
Orlando, Florida, United States
Triple O Research Institute PA
West Palm Beach, Florida, United States
Medical College of Georgia
Augusta, Georgia, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States
Mercer University School of Medicine
Macon, Georgia, United States
The Research Institute
Springfield, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Prime Health Care Services - St Michael's LLC d/b/a Saint Michael's Medical Center
Newark, New Jersey, United States
University of North Carolina at Chapel Hill / UNC School of Medicine
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
University of Cincinnati Med Center
Cincinnati, Ohio, United States
MetroHealth Medical Center IRB
Cleveland, Ohio, United States
North Texas Infectious Diseases Consultants
Dallas, Texas, United States
Trinity Health and Wellness Center
Fort Worth, Texas, United States
Gordon E. Crofoot MD PA
Houston, Texas, United States
Otto Wagner Spital
Vienna, , Austria
Hopital Henri Mondor
Créteil, , France
CHU de Nice-l Archet
Nice, , France
Hopital Bichat-Claude Bernard
Paris, , France
Hopital Saint Louis
Paris, , France
Centre Hospitalier de Tourcoing
Tourcoing, , France
Klinikum rechts der Isar, TUM
München, , Germany
Countries
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References
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Eron JJ Jr, Lelievre JD, Kalayjian R, Slim J, Wurapa AK, Stephens JL, McDonald C, Cua E, Wilkin A, Schmied B, McKellar M, Cox S, Majeed SR, Jiang S, Cheng A, Das M, SenGupta D. Safety of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in HIV-1-infected adults with end-stage renal disease on chronic haemodialysis: an open-label, single-arm, multicentre, phase 3b trial. Lancet HIV. 2018 Dec 13:S2352-3018(18)30296-0. doi: 10.1016/S2352-3018(18)30296-0. Online ahead of print.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Study Protocol: Amendment 2
Document Type: Study Protocol: Amendment 2.1
Other Identifiers
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2015-002713-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-292-1825
Identifier Type: -
Identifier Source: org_study_id