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

Gilead Sciences

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: HIV-1-infection

Treatments: Drug: BIC/LEN FDC; Drug: Bictegravir; Drug: Lenacapavir; Drug: Stable Baseline Regimen

Study type: Interventional

Funder types: Industry

Identifiers

NCT05502341

GS-US-621-6289

Details and patient eligibility

About

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).

Enrollment: 689 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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689 participants in 6 patient groups

Phase 2: Treatment Group 1: BIC 75 mg + LEN 25 mg

Experimental group

Description:

Participants will switch from their Stable Baseline Regimen (SBR) to a regimen of BIC 75 mg + LEN 25 mg, tablets administered orally once daily for up to 24 weeks. Participants will receive a 2-day pharmacokinetic (PK) oral loading dose of LEN 600 mg, on Days 1 and 2, in addition to the daily doses of BIC 75 mg + LEN 25 mg starting on Day 1. Participants who discontinue early or complete the Randomized Phase (RP) will have an option to continue in Extension Period (EP)

Treatment:

Drug: Lenacapavir

Drug: Bictegravir

Phase 2: Treatment Group 2: BIC 75 mg + LEN 50 mg

Experimental group

Description:

Participants will switch from their SBR to a regimen of BIC 75 mg + LEN 50 mg, tablets administered orally once daily for up to 24 weeks. Participants will receive a 2-day PK oral loading dose of LEN 600 mg, on Days 1 and 2, in addition to the daily doses of BIC 75 mg + LEN 50 mg starting on Day 1. Participants who discontinue early or complete the RP will have an option to continue in EP.

Treatment:

Drug: Lenacapavir

Drug: Bictegravir

Phase 2: Treatment Group 3: SBR

Active Comparator group

Description:

Participants will continue with their SBR for up to 24 weeks. Participants who discontinue early or complete the RP will have an option to continue in EP.

Treatment:

Drug: Stable Baseline Regimen

Phase 3: Treatment Group 1: BIC/LEN 75 mg/50 mg FDC

Experimental group

Description:

Participants will switch from their SBR to a regimen of BIC/LEN 75mg/50mg FDC, administered orally once daily for up to 48 weeks. Participants will receive a 2-day PK oral loading dose of LEN 600 mg, on Days 1 and 2, in addition to the daily doses of BIC/LEN 75 mg/50 mg FDC starting on Day 1. Participants who discontinue early or complete the RP will have an option to continue in EP.

Treatment:

Drug: BIC/LEN FDC

Phase 3: Treatment Group 2: SBR

Active Comparator group

Description:

Participants will continue with their SBR for up to 48 weeks. Participants who will discontinue early or complete the RP had an option to continue in EP.

Treatment:

Drug: Stable Baseline Regimen

Phase 2/Phase 3:BIC/LEN 75/50 mg FDC

Experimental group

Description:

At the end of randomized treatment, participants in Phase 2 and Phase 3 treatment groups who discontinue early or complete the RP will be given an option to enter in EP and will receive BIC/LEN 75/50 mg FDC until the drug is available in market or Gilead elects to withdraw the study. Participants in the SBR groups (Phase 2 Treatment Group 3 and Phase 3 Treatment Group 2 will also receive a 2-day PK oral loading dose of LEN 600 mg, on Days 1 and 2 of EP).

Treatment:

Drug: Lenacapavir

Drug: BIC/LEN FDC