Summary

for people ages 18 years and up (full criteria)
at UC Davis
study started
estimated completion:

Description

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.

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

Keywords

HIV-1 Infection end stage renal disease (ESRD) hemodialysis (HD) open-label E/C/F/TAF

Eligibility

For people ages 18 years and up

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/mm3; platelets ≥50,000/mm3; 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.

Locations

  • University of California Davis
    Sacramento California United States
  • Peter J Ruane MD Inc
    Los Angeles California United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT02600819
Phase
Phase 3
Study Type
Interventional
Last Updated