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Safety, Tolerability, Pharmacokinetics, and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis

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ClinicalTrials.gov Identifier: NCT02600819
Recruitment Status : Active, not recruiting
First Posted : November 9, 2015
Results First Posted : October 16, 2018
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in HIV-1 infected adults with end-stage renal disease (ESRD) on chronic hemodialysis (HD) at Week 48.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: E/C/F/TAF Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Subjects on Chronic Hemodialysis
Actual Study Start Date : December 14, 2015
Actual Primary Completion Date : September 29, 2017
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis HIV/AIDS

Arm Intervention/treatment
Experimental: E/C/F/TAF
Participants will switch their current antiretroviral regimen to E/C/F/TAF and receive treatment for 96 weeks.
Drug: E/C/F/TAF
E/C/F/TAF (150/150/200/10 mg) FDC tablets administered orally once daily
Other Name: Genvoya®




Primary Outcome Measures :
  1. Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 48 [ Time Frame: Up to 48 weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 96 [ Time Frame: Up to 96 weeks ]
  2. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm [ Time Frame: Week 24 ]
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 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.

  3. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm [ Time Frame: Week 48 ]
    The percentage of participants with 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.

  4. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the FDA Snapshot Algorithm [ Time Frame: Week 96 ]
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 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.

  5. Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG), Cobicistat (COBI), Emtricitabine (FTC), and Tenofovir (TFV) [ Time Frame: 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose ]
    AUCtau is defined as area under the concentration versus time curve over the dosing interval (i.e., concentration of drug over time).

  6. PK Parameter: AUClast of EVG, COBI, FTC, Tenofovir Alafenamide (TAF), and TFV [ Time Frame: 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose ]
    AUClast is defined as the area under the concentration versus time curve from time zero to the last observable concentration.

  7. PK Parameter: Cmax of EVG, COBI, FTC, TAF, and TFV [ Time Frame: 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose ]
    Cmax is defined as the maximum concentration of drug.

  8. PK Parameter: Ctau of EVG, COBI, FTC, and TFV [ Time Frame: 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose ]
    Ctau is defined as the observed drug concentration at the end of the dosing interval. Ctau has been presented in lieu of Cmin (specified in the protocol) to align with other Gilead studies. This change has no impact on the PK analysis as Ctau and Cmin are equivalent for all analytes.



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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:

  • Currently on a stable antiretroviral regimen for ≥ 6 consecutive months
  • Plasma HIV-1 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
  • 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)

Key Exclusion Criteria:

  • Hepatitis B co-infection
  • 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 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

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): NCT02600819


Locations
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United States, California
Peter J Ruane MD Inc
Los Angeles, California, United States
University of California Davis
Sacramento, California, United States
United States, Florida
Midway Immunology & Research Center, LLC
Fort 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
United States, Georgia
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
United States, Massachusetts
The Research Institute
Springfield, Massachusetts, United States
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States
United States, New Jersey
Prime Health Care Services - St Michael's LLC d/b/a Saint Michael's Medical Center
Newark, New Jersey, United States
United States, North Carolina
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
United States, Ohio
University of Cincinnati Med Center
Cincinnati, Ohio, United States
MetroHealth Medical Center IRB
Cleveland, Ohio, United States
United States, Texas
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
Austria
Otto Wagner Spital
Wien, Austria
France
Hopital Henri Mondor
Creteil, France
CHU de Nice-l Archet
NICE Cedex 03, France
Hopital Saint Louis
Paris Cedex 10, France
Hopital Bichat-Claude Bernard
Paris, France
Centre Hospitalier de Tourcoing
Tourcoing Cedex, France
Germany
Klinikum rechts der Isar, TUM
Munchen, Germany
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] July 8, 2015
Study Protocol: Amendment 1  [PDF] October 13, 2015
Study Protocol: Amendment 2  [PDF] November 28, 2016
Statistical Analysis Plan  [PDF] October 13, 2017


Publications of Results:
Eron JJ Jr, Lelievre J-D, Kalayjian R, Slim J, Wurapa AK, Stephens JL, et al. Safety and Efficacy of E/C/F/TAF in HIV-Infected Adults on Chronic Hemodialysis. Accepted for presentation at the Conference on Retroviruses and Opportunistic Infections (CROI); 2018, Mar 04-07, Boston, MA

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02600819     History of Changes
Other Study ID Numbers: GS-US-292-1825
2015-002713-30 ( EudraCT Number )
First Posted: November 9, 2015    Key Record Dates
Results First Posted: October 16, 2018
Last Update Posted: April 3, 2019
Last Verified: March 2019

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

Keywords provided by Gilead Sciences:
end stage renal disease (ESRD)
hemodialysis (HD)
open-label
HIV-1 Infection