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

HIV-1-infection Clinical Trial

— ARTISTRY-2  

Official title:

Phase 3 Double-blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy® (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06333808
• Other study ID #: GS-US-621-6290
• Secondary ID: 2023-510022-33
• Status: Recruiting
• Phase: Phase 3
• Start date: March 25, 2024
• Est. completion date: December 2029

Study information

• Verified date: April 2024
• Source: Gilead Sciences
• Contact: Gilead Clinical Study Information Center
• Phone: 1-833-445-3230 (GILEAD-0)
• Email: GileadClinicalTrials[@]gilead.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH). The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 546
• Est. completion date: December 2029
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Currently receiving B/F/TAF for at least 6 months prior to screening.
• If plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) measurements in the last 6 months prior to screening are available, all levels must be < 50 copies/mL.
• At least one documented 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.
• No documented or suspected resistance to BIC (including integrase strand-transfer inhibitor resistant (INSTI-R) mutations T66A/I/K, E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene).
• No documented or suspected resistance to tenofovir alafenamide (TAF) (TAF; mutations K65R, K65N, K70E, Q151M or T69 insertion, or = 3 of the following thymidine analog mutations [M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R] in the reverse transcriptase gene).
• Estimated glomerular filtration rate = 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance.

Key Exclusion Criteria:

• Positive serum pregnancy test or pregnant at screening or a positive pregnancy test prior to Day 1 randomization.
• Breastfeeding (nursing).
• Prior use of, or exposure to, LEN.
• Active, serious infections (other than HIV-1) requiring parenteral therapy < 30 days prior to randomization.
• Active tuberculosis infection.
• Acute hepatitis < 30 days before randomization.
• Chronic hepatitis B virus (HBV) infection, as determined by either:
• Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit.
• Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit.
• Known hypersensitivity to the study drug, its metabolites, or any formulation excipient.
• History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
• Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as determined by the investigator.
• Active malignancy requiring acute systemic therapy.
• Any of the following laboratory values at screening:
• Alanine aminotransferase > 5 × upper limit of normal (ULN).
• Direct bilirubin > 1.5 × ULN.
• Platelets < 50,000/mm^3.
• Hemoglobin < 8.0 g/dL.
• Requirement for ongoing therapy with or prior use of any prohibited medications listed in the protocol.
• Participation or planned participation in any other clinical study (including observational studies) without prior approval from the sponsor.
• Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Drug:
• Bictegravir
Tablets administered orally without regard to food
• Lenacapavir
Tablets administered orally without regard to food
• B/F/TAF
Tablets administered orally without regard to food
• Placebo to match B/F/TAF
Tablets administered orally without regard to food
• Placebo to match BIC/LEN
Tablets administered orally without regard to food

Locations

Country	Name	City	State
United States	Infectious Disease Specialists of Atlanta	Decatur	Georgia
United States	Therafirst Medical Center	Fort Lauderdale	Florida
United States	Midway Immunology and Research Center	Fort Pierce	Florida
United States	The Crofoot research Center, INC.	Houston	Texas
United States	Ruane Medical and Clinical Research Institute	Los Angeles	California
United States	Southhampton Community Healthcare, Inc.	Saint Louis	Missouri
United States	South Jersey Infectious Disease	Somers Point	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants with HIV-1 RNA = 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm		Week 48
Secondary	Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm		Week 48
Secondary	Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 48		Baseline; Week 48
Secondary	Treatment Group 1: Proportion of Participants with HIV-1 RNA = 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm		Week 96
Secondary	Treatment Group 1: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 96 as Determined by US FDA-defined Snapshot Algorithm		Week 96
Secondary	Treatment Group 1: Change from Baseline in CD4 Cell Count at Week 96		Baseline; Week 96
Secondary	Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) through Week 48		From first dose date up to Week 48
Secondary	Treatment Group 1: Percentage of Participants Experiencing Treatment-Emergent AEs through Week 96		From first dose date up to Week 96

External Links

•   Gilead Clinical Trials Website