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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06630299




Registration number
NCT06630299
Ethics application status
Date submitted
4/10/2024
Date registered
8/10/2024

Titles & IDs
Public title
Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1
Scientific title
A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Standard of Care
Secondary ID [1] 0 0
2024-514047-28
Secondary ID [2] 0 0
GS-US-563-5926
Universal Trial Number (UTN)
Trial acronym
ISLEND-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 - ISL/LEN
Treatment: Drugs - Antiretroviral Combinations

Experimental: ISL/LEN - Participants will receive an initial dose of ISL/LEN (Dose A), followed by once weekly ISL/LEN (Dose B) from Day 8 onwards up to Week 96.

Active comparator: Standard of Care Treatment - Participants will continue standard of care treatment with 2-3 ARVs up to Week 96:

* Integrase Strand Transfer Inhibitor (INSTI) class: INSTI combined with 1 or 2 nucleoside reverse transcriptase inhibitors (NRTIs; bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; coformulated; Biktarvy®), dolutegravir (DTG)/abacavir (ABC)/lamivudine (3TC), DTG+ TAF or TDF (TXF)/emtricitabine (FTC; Emtriva®), DTG/tenofovir disoproxil fumarate (TDF; Viread®)/3TC, DTG/3TC, raltegravir (RAL) + TXF/FTC, RAL+TDF/3TC, elvitegravir (EVG; Vitekta®)/cobicistat (c; Tybost®)/TXF/FTC), or
* PI class: Boosted protease inhibitor (PI) combined with 2 NRTIs (darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF; coformulated), boosted darunavir (DRV)+TXF/FTC, boosted DRV+TDF/3TC), or
* NNRTI class: Nonnucleoside reverse transcriptase inhibitor (NNRTI) combined with 2 NRTIs (doravirine (DOR)/TDF/3TC, DOR+TXF/FTC, DOR+TDF/3TC, rilpivirine (RPV)/TXF/FTC, RPV+TXF/FTC, RPV+TDF/3TC)

Experimental: Extension Phase - At the end of randomized treatment visit, if safety and efficacy of ISL/LEN are demonstrated following review of randomized data, participants will be given the option to receive ISL/LEN tablets in an extension phase until ISL/LEN becomes available or until the sponsor elects to discontinue the study, whichever occurs first.

Participants receiving ISL/LEN during the randomized phase will continue to take ISL/LEN weekly.

Participants receiving standard of care during the randomized phase will take an initial dose of ISL/LEN (Dose A), followed by once weekly ISL/LEN (Dose B) from Day 8 onwards.


Treatment: Drugs: ISL/LEN
Tablet administered orally

Treatment: Drugs: Antiretroviral Combinations
2 or 3 antiretrovirals (ARVs) administered as defined by the investigator, according to the prescribing information.
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 United States (US) Food and Drug Administration (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 96 as Determined by the US FDA-defined Snapshot Algorithm
Timepoint [1] 0 0
Week 96
Secondary outcome [2] 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 [2] 0 0
Week 48
Secondary outcome [3] 0 0
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
Change from Baseline in clusters of differentiation 4 (CD4) T-Cell Count at Week 48
Timepoint [4] 0 0
Baseline, Week 48
Secondary outcome [5] 0 0
Change from Baseline in CD4 T-Cell Count at Week 96
Timepoint [5] 0 0
Baseline, Week 96
Secondary outcome [6] 0 0
Proportion of Participants Discontinuing ISL/LEN due to Treatment-Emergent Adverse Events (TEAEs)
Timepoint [6] 0 0
First dose date up to Week 96

Eligibility
Key inclusion criteria
Key

* HIV-1 RNA < 50 copies/mL for = 6 months before screening, as documented by:

1. One HIV-1 RNA < 50 copies/mL immediately preceding the 24 weeks period prior to screening.
2. Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must be < 50 copies/mL.
3. During the 6 to 12 months period prior to screening, transient detectable viremia = 50 copies/mL is acceptable ("blip") as long as it is not confirmed on 2 consecutive visits.
* Plasma HIV-1 RNA levels < 50 copies/mL at screening.
* Are receiving guideline-recommended standard of care treatment such as International Antiviral Society (IAS), Department of Health and Human Services (DHHS), European AIDS Clinical Society (EACS) consisting of 2 or 3 ARVs for = 6 months prior to screening and willing to continue until Day 1. Individuals in Treatment Group 2 must also be willing to continue their standard of care through at least Week 96.
* Individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior virologic failure.
* Prior use of, or exposure to, ISL or LEN.
* Active, serious infections requiring parenteral therapy within 30 days before randomization.
* Active tuberculosis infection.
* Acute hepatitis within 30 days before randomization.
* Hepatitis B virus (HBV) infection, as determined below at the screening visit:

1. positive HBV surface antigen OR
2. positive HBV core antibody and negative HBV surface antibody. Note: individuals found to be susceptible to HBV infection (eg negative hepatitis B surface antibody at the screening visit, regardless of prior HBV vaccination history) should be recommended to receive HBV vaccination.
* Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA. Note: individuals with prior/inactive HCV infection (defined as undetectable HCV RNA) may be enrolled.
* Any of the following laboratory values at screening:

1. Creatinine clearance (CLcr) = 30 mL/min according to the Cockcroft-Gault formula
2. Alanine aminotransferase (ALT) > 5 x upper limit of normal (ULN)
3. Direct bilirubin > 1.5 x ULN
4. Platelets < 50,000/µL
5. Hemoglobin < 8.0 g/dL

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 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
8/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2030
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
East Sydney Doctors - Darlinghurst
Recruitment hospital [2] 0 0
Taylor Square Private Clinic - Darlinghurst
Recruitment hospital [3] 0 0
Prahran Market Clinic - South Yarra
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2011 - Darlinghurst
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
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New Mexico
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Japan
State/province [17] 0 0
Osaka Fu
Country [18] 0 0
Puerto Rico
State/province [18] 0 0
San Juan

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/NCT06630299