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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
12/11/2024

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
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United States of America
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Arizona
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California
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Connecticut
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Michigan
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Missouri
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New Mexico
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Buenos Aires
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Argentina
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Santa Fe
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Decarie Montreal
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Montreal
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Ottawa
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Regina
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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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Brescia
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Foggia
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Monza
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Pavia
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Roma
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Japan
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Aichi
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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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Seoul
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Mexico
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Merida
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Mexico City
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Badalona Barcelona
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Barcelona
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Valencia
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Kaohsiung City
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Taipei City
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Taoyuan City
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United Kingdom
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Liverpool
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United Kingdom
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London

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06333808
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06333808