AELIX Therapeutics and Gilead Sciences have entered a joint clinical research collaboration for the analysis of proprietary investigational products.
Called AELIX-003, the strategic clinical study aims to achieve a functional cure for HIV infection.
It will investigate the safety, tolerability, immunogenicity and efficacy of a regimen containing AELIX Therapeutics's HTI T-cell vaccine and Gilead's toll-like receptor 7 (TLR7) agonist vesatolimod in patients with HIV.
Around 90 patients enrolled at various clinical trial sites in Spain will participate in the double-blind, placebo-controlled study. Patients will have started antiretroviral therapy during early HIV infection.
Once the study begins, participants will be on antiretroviral therapy and their HIV viral loads will be controlled under the limits of detection.
They will be exposed to the vaccine/vesatolimod under careful monitoring, and will temporarily stop their antiretroviral drugs to determine if the intervention is effective in controlling their HIV levels.
The trial is expected to start early next year.
AELIX chief medical officer Dr Lance Berman said: “Maintenance of viral remission without antiretroviral therapy represents the next frontier in HIV treatment.
“We are excited to be collaborating with Gilead on this project, our first step to show the potential of our HTI immunogen as the backbone of combination regimens for maintenance of viral remission.”
The investigational potent and selective oral TLR7 agonist Vesatolimod is capable of activating plasmacytoid dendritic cells directly.
It is expected to activate expression of HIV in the body, as well as improving the vaccine-induced immune response, resulting in the removal of virus-infected cells.
Gilead is currently evaluating vesatolimod in virally suppressed HIV patients.