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 efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine (Emtriva®)/tenofovir alafenamide (Descovy®; F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (Truvada®; F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy®; B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance as determined by the proportion of participants with human immunodeficiency virus-1 ribonucleic acid (HIV-1 RNA) ≥ 50 copies/mL at Week 48

Official Title

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects Who Are Virologically Suppressed

Keywords

HIV-1-infectionTenofovirEmtricitabineEmtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationB/F/TAFF/TAFDTGDTG + F/TAF

Eligibility

For people ages 18 years and up

Key Inclusion Criteria:

  • Currently receiving an ARV regimen of DTG+F/TAF or DTG+F/TDF for the following minimum time periods:
  • ≥ 6 months (if there is documented or suspected nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance prior to the screening visit)
  • ≥ 3 months (if there is no documented or suspected NRTI resistance prior to the screening visit)
  • Documented plasma HIV-1 RNA < 50 copies/mL during treatment with DTG+F/TAF or DTG+F/TDF (for a minimum period of ≥ 6 or ≥ 3 months, as applicable) preceding the screening visit
  • Plasma HIV-1 RNA levels < 50 copies/mL at screening visit
  • Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance
  • No documented resistance to integrase stand transfer inhibitors (INSTIs) or confirmed virologic failure
  • Eligible adults with chronic hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection are permitted to enroll

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Locations

  • University of California Davis
    SacramentoCalifornia95817United States
  • Kaiser Permanente
    San FranciscoCalifornia94118United States
  • Positive Health Program SF General Hospital
    San FranciscoCalifornia94110United States
  • Mills Clinical Research
    Los AngelesCalifornia90069United States
  • Peter J. Ruane MD, Inc.
    Los AngelesCalifornia90036United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT03110380
Phase
Phase 3
Study Type
Interventional
Last Updated