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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06333808
Registration number
NCT06333808
Ethics application status
Date submitted
20/03/2024
Date registered
27/03/2024
Date last updated
25/03/2025
Titles & IDs
Public title
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
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Scientific 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
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Secondary ID [1]
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2023-510022-33
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Secondary ID [2]
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GS-US-621-6290
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Universal Trial Number (UTN)
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Trial acronym
ARTISTRY-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV-1-infection
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bictegravir
Treatment: Drugs - Lenacapavir
Treatment: Drugs - B/F/TAF
Treatment: Drugs - Placebo to match B/F/TAF
Treatment: Drugs - Placebo to match BIC/LEN
Experimental: Treatment Group 1: Bictegravir (BIC)/ Lenacapavir (LEN) (75/50 mg) + PTM B/F/TAF - Blinded Phase: Participants will switch from bictegravir/emtricitabine/tenofovir (B/F/TAF) FDC tablets to BIC/LEN (75/50 mg) FDC tablets and placebo-to-match (PTM) B/F/TAF. Participants will receive a 2-day oral loading dose of LEN 600 mg on Day 1 and on Day 2, in addition to the daily doses of BIC/LEN FDC tablet starting on Day 1 up to end of blinded treatment (EBT) visit.
Open-label (OL) Phase: Following treatment in the Blinded Phase, participants from Treatment Group 1 will receive BIC/LEN FDC tablets through Week 48 in the Open-label Phase. At the OL Week 48 visit, participants from Treatment Group 1 will be given the option to continue to receive BIC/LEN FDC tablets until the conclusion of the OL Phase.
Experimental: Treatment Group 2: B/F/TAF (50/200/25 mg) + PTM BIC/LEN - Blinded Phase: Participants will continue with their B/F/TAF (50/200/25 mg) FDC tablets and start PTM BIC/LEN tablets on Day 1. Participants will receive PTM LEN tablets for 2 days (2 PTM LEN tablets on Day 1 and on Day 2. The blinded phase will continue until the EBT visit.
Open Label Phase: Participants in Treatment Group 2 who complete the EBT visit will be given the option to enter the OL phase to receive BIC/LEN FDC tablets until the conclusion of the OL Phase.
Treatment: Drugs: Bictegravir
Tablets administered orally without regard to food
Treatment: Drugs: Lenacapavir
Tablets administered orally without regard to food
Treatment: Drugs: B/F/TAF
Tablets administered orally without regard to food
Treatment: Drugs: Placebo to match B/F/TAF
Tablets administered orally without regard to food
Treatment: Drugs: Placebo to match BIC/LEN
Tablets administered orally without regard to food
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of Participants with HIV-1 RNA = 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
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Assessment method [1]
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Timepoint [1]
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Week 48
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Secondary outcome [1]
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Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
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Assessment method [1]
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Timepoint [1]
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Week 48
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Secondary outcome [2]
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Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 48
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Assessment method [2]
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Timepoint [2]
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Baseline; Week 48
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Secondary outcome [3]
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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
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Assessment method [3]
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Timepoint [3]
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Week 96
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Secondary outcome [4]
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Treatment Group 1: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 96 as Determined by US FDA-defined Snapshot Algorithm
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Assessment method [4]
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Timepoint [4]
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Week 96
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Secondary outcome [5]
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Treatment Group 1: Change from Baseline in CD4 Cell Count at Week 96
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Assessment method [5]
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Baseline; Week 96
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Secondary outcome [6]
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Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) through Week 48
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Assessment method [6]
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Timepoint [6]
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From first dose date up to Week 48
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Secondary outcome [7]
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Treatment Group 1: Percentage of Participants Experiencing Treatment-Emergent AEs through Week 96
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Assessment method [7]
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Timepoint [7]
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From first dose date up to Week 96
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Eligibility
Key inclusion criteria
Key
* 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/03/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2029
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Actual
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Sample size
Target
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Accrual to date
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Final
577
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Taylor Square Private Clinic - Darlinghurst
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Alfred Hospital(Alfred Health) - Melbourne
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Prahran Market Clinic - South Yarra
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2011 - Darlinghurst
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3004 - Melbourne
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3141 - South Yarra
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT06333808
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gilead Study Director
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Address
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Gilead Sciences
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Contact person for public queries
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Gilead Clinical Study Information Center
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Phone
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1-833-445-3230 (GILEAD-0)
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06333808
Download to PDF