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



The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC) plus lenacapavir (LEN), versus current therapy (Phase 2) and BIC/LEN fixed-dose combination (FDC) versus current therapy (Phase 3) in people living with HIV (PWH).

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


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


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...

  • Prior use of, or exposure to, lenacapavir (LEN)
  • Active tuberculosis infection
  • Chronic hepatitis B virus (HBV) infection

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


  • University of California San Diego (UCSD)
    San Diego California 92103 United States
  • Bios Clinical Research
    Palm Springs California 92262 United States


in progress, not accepting new patients
Start Date
Completion Date
Gilead Sciences
Gilead Clinical Trials Website
Phase 2/3 HIV/AIDS Research Study
Study Type
Expecting 671 study participants
Last Updated