Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

Summary

The primary objectives of this study are to evaluate the efficacy of switching to a bictegravir (BIC) plus lenacapavir (LEN) regimen versus continuing on stable baseline regimen (SBR) in virologically suppressed people with human immunodeficiency virus (PWH) (Phase 2) and to evaluate the efficacy of switching to BIC/LEN fixed-dose combination (FDC) tablet regimen versus continuing on a SBR in virologically suppressed PWH (Phase 3).

Official Title

An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens

Keywords

HIV-1-infection, Bictegravir, Lenacapavir, BIC/LEN FDC, Stable Baseline Regimen, Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mg, BIC 75 mg + LEN 50 mg

Eligibility

You can join if…

Open to people ages 18 years and up

  • Documented plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels < 50 copies/mL during treatment with the baseline regimen for a minimum period of 6 months prior to the screening visit.
  • Plasma HIV-1 RNA levels < 50 copies/mL at screening.
  • Currently receiving a complex antiretroviral (ARV) regimen due to previous viral resistance, or intolerance, or contraindication to existing single-tablet regimens (STR). The criteria to define a complex regimen in this study are as follows:
  • A regimen containing a boosted protease inhibitor or a nonnucleos(t)ide reverse transcriptase inhibitor (NRTI) plus at least 1 other third agent (ie, an agent from a class other than NRTIs) (eg, bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®)(BVY) + darunavir/cobicistat, BVY + etravirine), or
  • A regimen of ≥ 2 pills/day, or a regimen requiring dosing more than once daily, or
  • A regimen containing parenteral agent(s) (excluding a complete long-acting injectable regimen, such as intramuscular cabotegravir plus rilpivirine) as well as oral agents.
  • No documented or suspected resistance to bictegravir (BIC).
  • Estimated glomerular filtration rate ≥ 15 mL/min according to the Cockcroft-Gault formula for creatinine clearance (CLcr) who are not on renal replacement therapy.

You CAN'T join if...

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

Locations

  • University of California San Diego (UCSD) accepting new patients
    San Diego California 92103 United States
  • Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center accepting new patients
    Torrance California 90502 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
Links
Gilead Clinical Trials Website
ID
NCT05502341
Phase
Phase 2/3 HIV/AIDS Research Study
Study Type
Interventional
Participants
Expecting 671 study participants
Last Updated