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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

Titles & IDs
Public title
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
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
Secondary ID [1] 0 0
2023-510022-33
Secondary ID [2] 0 0
GS-US-621-6290
Universal Trial Number (UTN)
Trial acronym
ARTISTRY-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-1-infection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Participants with HIV-1 RNA = 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
Timepoint [1] 0 0
Week 48
Secondary outcome [1] 0 0
Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
Timepoint [1] 0 0
Week 48
Secondary outcome [2] 0 0
Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 48
Timepoint [2] 0 0
Baseline; Week 48
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Week 96
Secondary outcome [4] 0 0
Treatment Group 1: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 96 as Determined by US FDA-defined Snapshot Algorithm
Timepoint [4] 0 0
Week 96
Secondary outcome [5] 0 0
Treatment Group 1: Change from Baseline in CD4 Cell Count at Week 96
Timepoint [5] 0 0
Baseline; Week 96
Secondary outcome [6] 0 0
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) through Week 48
Timepoint [6] 0 0
From first dose date up to Week 48
Secondary outcome [7] 0 0
Treatment Group 1: Percentage of Participants Experiencing Treatment-Emergent AEs through Week 96
Timepoint [7] 0 0
From first dose date up to Week 96

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.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2029
Actual
Sample size
Target
546
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Taylor Square Private Clinic - Darlinghurst
Recruitment hospital [2] 0 0
Alfred Hospital(Alfred Health) - Melbourne
Recruitment hospital [3] 0 0
Prahran Market Clinic - South Yarra
Recruitment postcode(s) [1] 0 0
2011 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
3141 - South Yarra
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
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United States of America
State/province [4] 0 0
Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Missouri
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United States of America
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New Jersey
Country [11] 0 0
United States of America
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New Mexico
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United States of America
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New York
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North Carolina
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Pennsylvania
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South Carolina
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Texas
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Utah
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Virginia
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Washington
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Canada
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Decarie Montreal
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Canada
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Montreal
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Canada
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Ottawa
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Canada
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Regina
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Canada
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Vancouver
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Canada
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Victoria
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Dominican Republic
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Santo Domingo
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Germany
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Aachen
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Germany
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Berlin
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Köln
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Germany
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Munchen
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Germany
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Munich
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Italy
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Brescia
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Italy
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Foggia
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Italy
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Milano
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Italy
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Monza
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Italy
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Pavia
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Italy
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Roma
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Japan
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Aichi
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Japan
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Osaka
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Japan
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Tokyo
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Mexico
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Merida
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Mexico
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Mexico City
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Puerto Rico
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San Juan
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Spain
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Badalona Barcelona
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Taiwan
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Kaohsiung City
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Taiwan
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Kaohsiung
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Taiwan
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Taipei City
Country [58] 0 0
Taiwan
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Taoyuan City
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Liverpool
Country [60] 0 0
United Kingdom
State/province [60] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gilead Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-833-445-3230 (GILEAD-0)
Fax 0 0
Email 0 0
GileadClinicalTrials@gilead.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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