AELIX will conduct a randomized, placebo-controlled phase 1/2 trial in HIV-1 infected participants. This AELIX-002 study will evaluate the ability of a combination of HIV-1 vaccines to induce functional cure of HIV infection. A total of 45 HIV-1 infected participants will be enrolled in the study, which will be conducted at the Hospital Universitari Germans Trias i Pujol (Badalona, Spain). After completion of a vaccine or placebo regimen, participants will undergo a 24-week analytical treatment interruption (ATI) period, during which plasma viral load (PVL) will be monitored on a weekly basis.
Biological samples (plasma, peripheral blood mononuclear cells and faeces) will be collected at baseline, after each vaccination, before the ATI, after the ATI and after 12 weeks of antiretroviral treatment resumption.
MISTRAL will determine whether the vaccine regimen modulates the baseline intestinal microbiome. Changes in microbial composition, richness, diversity and function will be longitudinally evaluated over the course of the AELIX-002 study. On study completion, researchers will make data available after taking necessary measures to protect intellectual property in the iVIHome integrated web resource (WP11). Predictors of HIV vaccine response will be entered for automated microbiome data analysis (WP8) in the Enthera software platform, which will furnish clinicians and clinical trial technologists with HIV-infected subjects most likely to respond to HIV-1 cure/immunotherapy interventions.
- To evaluate whether a therapeutic HIV vaccine regimen alters the gut microbiome.
- To determine whether the baseline microbiome defines immunological and virological responses to a vaccine regimen used to induce functional cure of HIV-1 infection.
- To determine whether baseline microbiome characteristics determine the immunological and virological responses to the vaccine regimen.
To create a comprehensive biorepository that can be used to evaluate interactions between the gut microbiome and the HIV-1 reservoir.