ENTRANCE
Research type
Research Study
Full title
An exploratory Phase 1b, multicenter, randomised, open-label study to investigate the impact of the administration of intravenous VH3810109 with or without oral fostemsavir in combination with integrase inhibitor-based antiretroviral therapy on the viral reservoir in adults living with HIV-1.
IRAS ID
1012110
Contact name
N/A N/A
Contact email
Sponsor organisation
ViiV Healthcare UK Limited- London
Research summary
Human immunodeficiency virus (HIV) is a virus that affects the immune system. HIV is treated using antiretroviral therapy (ART). While ART is highly effective at controlling HIV, it does not eliminate the virus from the body, and the virus starts multiplying again when treatment is stopped. Because HIV can stay “hidden” and inactive in the body, it becomes very difficult to completely eliminate the virus, even with treatment. Understanding HIV that is hidden in the body is important for researchers aiming to eventually develop a cure. They are working on ways to target and eliminate the virus from these hiding spots. This study will look at the effects of 2 study medicines: N6LS (also known as VH3810109) and fostemsavir (FTR). Researchers want to find out if these medicines, given in addition to standard HIV treatment, will reduce the amount of HIV inside certain immune cells. In the second part of the study, participants will pause all HIV treatment (called an analytical treatment interruption [ATI]) for up to 12 weeks to see if having taken the study medicines helps control HIV without treatment. This study will include people with HIV who have never taken ART before, as well as people currently taking ART. About 100 participants (50 from each group) will be enrolled. The study is open label, meaning both the participants and the study doctors know which treatments are being administered. Participants will be randomly placed into one of three groups: Group 1: In this group, participants either start or continue taking standard HIV treatment (integrase inhibitor [INI]-based ART) for 15 months. Group 2: In addition to their INI-based ART, participants receive N6LS. Group 3: Participants receive the same treatment as Group 2 but also take FTR. Participants can be included in the study if they are between 18 and 70 years old, have a confirmed diagnosis of HIV and are taking INI-based ART and have been on HIV treatment for at least 2 years (already receiving treatment)
REC name
London - Central Research Ethics Committee
REC reference
25/LO/0477
Date of REC Opinion
29 Jul 2025
REC opinion
Further Information Favourable Opinion