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Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen

NCT05502341

Active Not RecruitingPhase 2, Phase 3

Sponsor: Gilead Sciences

Conditions: HIV-1-infection

Interventions: Bictegravir, Lenacapavir, BIC/LEN FDC, Stable Baseline Regimen

Countries: United States, Argentina, Australia, Canada, Dominican Republic, France, Germany, Italy

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

* If plasma HIV-1 RNA measurements in the 6 months prior to screening are available, all levels must be \< 50 copies/mL.
* At least one documented plasma HIV-1 RNA level measured between 6 and 12 months (± 2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be \< 50 copies/mL
* 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), and on this regimen for at least 6 months prior to the screening visit. 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.

Key Exclusion Criteria:

* 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.

Locations (94)

Berkeley, California, United States
Beverly Hills, California, United States
Los Angeles, California, United States
Oakland, California, United States
Palm Springs, California, United States
San Diego, California, United States
Torrance, California, United States
West Hollywood, California, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
DeLand, Florida, United States
Fort Lauderdale, Florida, United States
Fort Lauderdale, Florida, United States
Ft. Pierce, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Macon, Georgia, United States
Chicago, Illinois, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Newark, New Jersey, United States
Santa Fe, New Mexico, United States
Flushing, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Greenville, North Carolina, United States
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