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
HIV-1 Infection
About this trial
This is an interventional treatment trial for HIV-1 Infection focused on measuring End stage renal disease, Hemodialysis, Open-label, HIV-1 Infection
Eligibility Criteria
Key Inclusion Criteria:
- Currently on a stable antiretroviral regimen for ≥ 6 consecutive months
- 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)
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 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Peter J Ruane MD Inc
- University of California Davis
- Midway Immunology & Research Center, LLC
- Infectious Disease Consultants, M.D., P.A. d/b/a Orlando Immunology Center
- Triple O Research Institute PA
- Medical College of Georgia
- Infectious Disease Specialists of Atlanta
- Mercer University School of Medicine
- The Research Institute
- Henry Ford Health System
- Prime Health Care Services - St Michael's LLC d/b/a Saint Michael's Medical Center
- University of North Carolina at Chapel Hill / UNC School of Medicine
- Duke University
- Wake Forest University Baptist Medical Center
- University of Cincinnati Med Center
- MetroHealth Medical Center IRB
- North Texas Infectious Diseases Consultants
- Trinity Health and Wellness Center
- Gordon E. Crofoot MD PA
- Otto Wagner Spital
- Hopital Henri Mondor
- CHU de Nice-l Archet
- Hopital Saint Louis
- Hopital Bichat-Claude Bernard
- Centre Hospitalier de Tourcoing
- Klinikum rechts der Isar, TUM
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
E/C/F/TAF
Open-Label Rollover Extension B/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.
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.