ISLEND-1
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir (B/F/TAF)
IRAS ID
1010681
Contact name
Sharline Madera
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2024-514046-37
Clinicaltrials.gov Identifier
Research summary
This is a randomised, double-blinded study with an optional open-label period. There will be about 600 participants in the study. The study will take place at about 110 locations around the world. Researchers are running this research study to learn about taking ISL/LEN once a week compared to taking Biktarvy® (B/F/TAF) every day in people living with HIV.
The purpose of this study is to learn more about the experimental drug, ISL/LEN. This will include:
⦁ Comparing ISL/LEN weekly to Biktarvy® daily and determining which of these treatments works better for treating HIV infection.
⦁ Determining how ISL/LEN and Biktarvy® affects the HIV infection in the body.
⦁ Testing and learning about the safety of ISL/LEN, how well ISL/LEN is tolerated, and how long it stays in the body using physical exam, blood and urine tests, and any symptoms or problems the participants might experience during the study.
Oral coadministration of ISL and LEN has the potential to offer a safe, efficacious, and well tolerated once weekly regimen to treat HIV-1 infection. The 2 agents in combination are predicted to be effective for treatment of HIV-1 infection due to their different mechanisms of action and nonoverlapping resistance profiles. The data from this study are intended to support the filing of an oral weekly regimen of ISL/LEN.An active control group of Biktarvy® (B/F/TAF) is included as a current standard of care comparator allowing those participants not randomized to ISL/LEN to continue to receive highly effective treatment.
Taking part in the randomized period of this study may last about 2 years. After the end of randomised treatment visit, if participants choose to take part in the extension period, they will be given ISL/LEN until one of the following things happen: ISL/LEN becomes available and can be accessed outside of this study, the study doctor has decided it is not in their best interest, or the participant chooses to no longer take part in the study.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
24/NE/0181
Date of REC Opinion
11 Nov 2024
REC opinion
Further Information Favourable Opinion