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

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.