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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05502341




Registration number
NCT05502341
Ethics application status
Date submitted
5/08/2022
Date registered
16/08/2022

Titles & IDs
Public title
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen
Scientific 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
Secondary ID [1] 0 0
2022-500929-33
Secondary ID [2] 0 0
GS-US-621-6289
Universal Trial Number (UTN)
Trial acronym
ARTISTRY-1
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 - BIC/LEN FDC
Treatment: Drugs - Stable Baseline Regimen

Experimental: Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mg - Participants will switch from their stable baseline regimen (SBR) to a regimen of BIC 75 mg + LEN 25 mg. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC 75 mg + LEN 25 mg starting on Day 1 up to the end of randomized treatment (ERT) visit, participants will be treated for at least 24 weeks during the Randomized Period.

Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg fixed dose combination (FDC).

Experimental: Phase 2: BIC 75 mg + LEN 50 mg - Participants will switch from their SBR to a regimen of BIC 75 mg + LEN 50 mg. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC 75 mg + LEN 50 mg starting on Day 1 up to the ERT visit, participants will be treated for at least 24 weeks during the Randomized Period.

Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.

Active comparator: Phase 2: Stable Baseline Regimen (SBR) - Participants will continue with their SBR per prescription for up to the ERT visit, participants will be treated for at least 24 weeks during the Randomized Period.

Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.

Experimental: Phase 3: BIC/LEN 75 mg/50 mg Fixed-dose Combination (FDC) - Participants will switch from their SBR to a regimen of BIC/LEN 75 mg/50 mg FDC. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC/LEN 75 mg/50 mg FDC starting on Day 1 up to the ERT visit, participants will be treated for at least 48 weeks during the Randomized Period.

Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.

Active comparator: Phase 3: Stable Baseline Regimen - Participants will continue with their SBR per prescription for up to the ERT visit, participants will be treated for at least 48 weeks during the Randomized Period.

Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.


Treatment: Drugs: Bictegravir
Tablets administered orally without regard to food

Treatment: Drugs: Lenacapavir
Tablets administered orally without regard to food

Treatment: Drugs: BIC/LEN FDC
Tablets administered orally without regard to food

Treatment: Drugs: Stable Baseline Regimen
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 2: Proportion of Participants With HIV-1 RNA = 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm
Timepoint [1] 0 0
Week 24
Primary outcome [2] 0 0
Phase 3: Proportion of Participants With HIV-1 RNA = 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
Timepoint [2] 0 0
Week 48
Secondary outcome [1] 0 0
Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Phase 2: Change From Baseline in CD4 Cell Count at Week 24
Timepoint [2] 0 0
Baseline, Week 24
Secondary outcome [3] 0 0
Phase 2: Percentage of Participants Experiencing Treatment-emergent Adverse Events (AEs) Through Week 24
Timepoint [3] 0 0
First dose date up to Week 24
Secondary outcome [4] 0 0
Phase 2: Pharmacokinetic (PK) Parameter: Cmax of Bictegravir (BIC) and Lenacapavir (LEN) at Steady State
Timepoint [4] 0 0
Day 1 up to Week 24
Secondary outcome [5] 0 0
Phase 2: PK Parameter: AUCtau of BIC and LEN at Steady State
Timepoint [5] 0 0
Day 1 up to Week 24
Secondary outcome [6] 0 0
Phase 2: PK Parameter: Ctau of BIC and LEN at Steady State
Timepoint [6] 0 0
Day 1 up to Week 24
Secondary outcome [7] 0 0
Phase 3: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
Timepoint [7] 0 0
Week 48
Secondary outcome [8] 0 0
Phase 3: Change From Baseline in CD4 Cell Count at Week 48
Timepoint [8] 0 0
Baseline, Week 48
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Week 96
Secondary outcome [10] 0 0
Phase 3 (BIC/LEN 75 mg/50 mg FDC): Change From Baseline in CD4 Cell Count at Week 96
Timepoint [10] 0 0
Baseline, Week 96
Secondary outcome [11] 0 0
Phase 3: Percentage of Participants Experiencing Treatment-emergent AEs Through Week 48
Timepoint [11] 0 0
First dose date up to Week 48
Secondary outcome [12] 0 0
Phase 3 (BIC/LEN 75 mg/50 mg FDC): Proportion of Participants from Experiencing Treatment-emergent AEs Through Week 96
Timepoint [12] 0 0
Week 96

Eligibility
Key inclusion criteria
Key

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

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2028
Actual
Sample size
Target
Accrual to date
Final
689
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St.Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Taylor Square Private Clinic - Darlinghurst
Recruitment hospital [3] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [4] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2011 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
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New Mexico
Country [10] 0 0
United States of America
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New York
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United States of America
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North Carolina
Country [12] 0 0
United States of America
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Pennsylvania
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South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Argentina
State/province [16] 0 0
Buenos Aires
Country [17] 0 0
Canada
State/province [17] 0 0
Decarie Montreal
Country [18] 0 0
Canada
State/province [18] 0 0
Montreal
Country [19] 0 0
Canada
State/province [19] 0 0
Ottawa
Country [20] 0 0
Canada
State/province [20] 0 0
Regina
Country [21] 0 0
Canada
State/province [21] 0 0
Toronto
Country [22] 0 0
Canada
State/province [22] 0 0
Vancouver
Country [23] 0 0
Dominican Republic
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Santo Domingo
Country [24] 0 0
France
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Nice Cedex 03
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France
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Paris Cedex 13
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France
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Paris
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Germany
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Berlin
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Germany
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Bonn
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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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München
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Italy
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Milano
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Italy
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Modena
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Italy
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Roma
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Italy
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Torino
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Japan
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Nagoya
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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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Daejeon
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Korea, Republic of
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Seoul
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Puerto Rico
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San Juan
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South Africa
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Cape Town
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South Africa
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Ga Rankuwa
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South Africa
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Johannesburg
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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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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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New Taipei City
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Taiwan
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Taoyuan City
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United Kingdom
State/province [53] 0 0
Birmingham
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Brighton
Country [55] 0 0
United Kingdom
State/province [55] 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/NCT05502341