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NCT Number: NCT05502341

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV-1-infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Fundación Huésped, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bictegravir

Drug

Tablets administered orally without regard to food

Other names: GS-9883

Lenacapavir

Drug

Tablets administered orally without regard to food

Other names: GS-6207

BIC/LEN FDC

Drug

Tablets administered orally without regard to food

Stable Baseline Regimen

Drug

SBR will include a combination of antiretroviral (ARV) regimen. ARV regimen may include the following, except for participants taking a single tablet regimen or taking a complete parenteral regimen (Cabenuva).

  • Nucleos(t)ide Reverse Transcriptase Inhibitors:
  • Abacavir
  • Emtricitabine
  • Lamivudine
  • Tenofovir alafenamide
  • Tenofovir disoproxil fumarate
  • Zidovudine
  • Non-Nucleosite Reverse Transcriptase Inhibitors:
  • Delavirdine
  • Efavirenz
  • Nevirapine
  • Rilpivirine
  • Doravirine
  • Integrase Inhibitors:
  • Bictegravir
  • Cabotegravir
  • Dolutegravir
  • Elvitegravir
  • Raltegravir
  • Protease Inhibitors:
  • Atazanavir
  • Darunavir
  • Fosamprenavir
  • Indinavir
  • Lopinavir
  • Nelfinavir
  • Saquinavir
  • Tipranavir
  • Chemokine Co-receptor 5 (CCR5) Antagonist:
  • Maraviroc
  • Fusion Inhibitors:
  • Enfuvirtide
  • gp120 Attachment Inhibitor:
  • Fostemsavir
  • Anti-CD4 Monoclonal Antibodies:
  • Ibalizumab-uiyk

Primary outcomes

  1. Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm

    Time frame: Week 24

  2. Phase 3: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm

    Time frame: Week 48

Secondary outcomes

  1. Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm

    Time frame: Week 24

  2. Phase 2: Change From Baseline in CD4 Cell Count at Week 24

    Time frame: Baseline, Week 24

  3. Phase 2: Percentage of Participants Experiencing Treatment-emergent Adverse Events (AEs) Through Week 24

    Time frame: First dose date up to Week 24

  4. Phase 2: Pharmacokinetic (PK) Parameter: Cmax of Bictegravir (BIC) and Lenacapavir (LEN) at Steady State

    Time frame: Day 1 up to Week 24

    Cmax is defined as the maximum observed concentration of drug.

  5. Phase 2: PK Parameter: AUCtau of BIC and LEN at Steady State

    Time frame: Day 1 up to Week 24

    AUCtau is defined as the area under the concentration versus time curve over the dosing interval.

  6. Phase 2: PK Parameter: Ctau of BIC and LEN at Steady State

    Time frame: Day 1 up to Week 24

    Ctau is defined as the observed drug concentration at the end of the dosing interval.

  7. Phase 3: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm

    Time frame: Week 48

  8. Phase 3: Change From Baseline in CD4 Cell Count at Week 48

    Time frame: Baseline, Week 48

  9. Phase 3 (BIC/LEN 75 mg/50 mg FDC): Proportion of Participants from With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm

    Time frame: Week 96

  10. Phase 3 (BIC/LEN 75 mg/50 mg FDC): Change From Baseline in CD4 Cell Count at Week 96

    Time frame: Baseline, Week 96

  11. Phase 3: Percentage of Participants Experiencing Treatment-emergent AEs Through Week 48

    Time frame: First dose date up to Week 48

  12. Phase 3 (BIC/LEN 75 mg/50 mg FDC): Proportion of Participants from Experiencing Treatment-emergent AEs Through Week 96

    Time frame: Week 96

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Acronym: ARTISTRY-1

Important dates

Study start
2022
Primary completion
2025
Study completion
2028
First posted
Aug 16, 2022
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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