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
Condition: HIV-1 Infection
MeSH terms: Infections
Intervention: E/C/F/TAF; B/F/TAF
Intervention description: 150/150/200/10 mg FDC tablets administered orally once daily; 50/200/25 mg FDC tablets administered orally once daily
Intervention MeSH terms: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: End stage renal disease; Hemodialysis; Open-label; HIV-1 Infection

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 human immunodeficiency virus (HIV-1) infected adults with end-stage
      renal disease (ESRD) on chronic hemodialysis (HD).
    

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.