ISLEND-2
Research type
Research Study
Full 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
IRAS ID
1010678
Contact name
Hadas Dvory-Sobol
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2024-514047-28
Clinicaltrials.gov Identifier
Research summary
This is a randomized, open-label, active-controlled study to evaluate taking ISL/LEN once a week compared to taking a prescribed treatment 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 weekly oral ISL/LEN to daily oral prescribed treatment and determining which of these treatments works better for treating HIV infection
• Determining how ISL/LEN affects the HIV infection in the body
• Testing and learning about the safety of ISL/LEN, how well it is tolerated, and how long it stays in the body using physical exams, blood and urine tests, and any symptoms or problems 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. An active control group including people receiving guideline-recommended oral therapy (per guidelines such as IAS, DHHS, and EACS) consisting of 2 or 3 ARVs is included as a current standard of care comparator allowing those participants not randomized to ISL/LEN FDC to continue to receive highly effective treatment. This study will allow comparison of the once weekly ISL/LEN with once daily regimens that are commonly used today.
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 1 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
London - Hampstead Research Ethics Committee
REC reference
24/LO/0755
Date of REC Opinion
3 Dec 2024
REC opinion
Further Information Favourable Opinion