Study to Compare Bictegravir/​Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy (ARTISTRY-2)

STUDY OVERVIEW

The goal of this clinical study sponsored by Gilead Sciences is to evaluate the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN) fixed-dose combination (FDC), compared to continuing with current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in virologically suppressed people living with HIV-1 (PWH).

STUDY GOALS

The goal of this study is to evaluate the effectiveness of switching to bictegravir/lenacapavir fixed-dose combination versus continuing on bictegravir/emtricitabine/tenofovir alafenamide fixed-dose combination in virologically suppressed individuals living with HIV-1.

LOCATION

El Paso, Texas: AXCES Research Group

INCLUSION CRITERIA

  • Currently on B/F/TAF for at least 6 months before screening.

  • HIV-1 RNA levels < 50 copies/mL in all measurements in the last 6 months.

  • Documented HIV-1 RNA level < 50 copies/mL between 6 and 12 months prior to screening.

  • Plasma HIV-1 RNA levels < 50 copies/mL at screening.

  • No resistance to BIC or TAF.

  • Estimated glomerular filtration rate ≥ 30 mL/min (Cockcroft-Gault formula).

exclusion criteria

  • Positive pregnancy test at screening or before Day 1 randomization.

  • Breastfeeding.

  • Prior use or exposure to LEN.

  • Serious infections (other than HIV-1) needing parenteral therapy within 30 days before randomization.

  • Active tuberculosis.

  • Acute hepatitis within 30 days before randomization.

  • Chronic hepatitis B virus (HBV) infection.

  • Known hypersensitivity to study drug or its components.

  • History or current decompensated liver cirrhosis.

  • Clinically significant abnormal ECG.

  • Active malignancy needing acute systemic therapy.

  • Abnormal lab values at screening (ALT > 5× ULN, direct bilirubin > 1.5× ULN, platelets < 50,000/mm³, hemoglobin < 8.0 g/dL).

  • Need for ongoing or prior use of prohibited medications.

  • Participation in another clinical study without sponsor approval.

  • Any condition or prior therapy deemed unsuitable by the investigator.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

For more information, visit ClinicalTrials.gov.