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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

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

Watanabe Takanobu

Gilead Sciences K.K.

1-9-2, Marunouchi, Chiyoda-ku, Tokyo

ClinicalTrialGSJ@gilead.com

Clinical Operations

Gilead Sciences K.K.

1-9-2, Marunouchi, Chiyoda-ku, Tokyo

+81-3-6837-0740

JPClinicalOperations@gilead.com

Recruiting

Jan. 29, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

-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(R))(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.

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

Both

HIV-1-Infection

-Experimental: Phase 3: BIC/LEN 75 mg/50 mg Fixed-dose Combination (FDC)
Participants will switch from their SBR to a regimen of BIC/LEN 75 mg/50 mg FDC Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC/LEN 75 mg/50 mg FDC starting on Day 1 up to the ERT visit, participants will be treated for at least 48 weeks during the Randomized Period.

-Active Comparator: Phase 3: Stable Baseline Regimen
Participants will continue with their SBR per prescription for up to the ERT visit, participants will be treated for at least 48 weeks during the Randomized Period.

Following Randomized Period, the participants in both arms will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.

Proportion of participants with HIV-1 RNA 50 or more copies/mL at Week 48 as determined by the US FDA-defined snapshot algorithm

- Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 48, Week 96 as determined by the US FDA-defined snapshot algorithm
- Change from baseline in CD4 cell count at Week 48, Week 96.
- Proportion of participants experiencing treatment emergent AEs through Week 48, and Week 96.

No

US/Australia/Canada/Dominican Republic/Puerto Rico/France/Germany/Italy/Korea/South Africa/Spain/Taiwan/United Kingdom/Argentina