Objectives

The main goal of HIVACAR is to change the current paradigm of HIV treatment by obtaining a functional cure for HIV (i.e., control of viral load to levels below the threshold of 50 copies/ml and maintenance of high CD4+ T-cell count after discontinuation of antiretroviral therapy) by effectively targeting residual virus replication and viral reservoirs. In order to do so, the proposed novel strategy is to successfully combine immune-based therapies, including therapeutic vaccines and broadly neutralizing antibodies with latency reversing agents, in a proof-of-concept phase I/IIa clinical trial. HIVACAR project will is expected to lead to a reduction of 15-30% of the actual costs related to HIV treatment and management, and 5-10% of the social public health, based on a conservative scenario on the rate of success and the proportion of the public health budget devoted to HIV, and a positive effect in economic growth4. The project will also lead to an improvement in the patients’ quality of life. HIVACAR project has been conceived under the framework of responsible research and innovation, so patients and other stakeholders will have a key role from the inception of the project until obtaining the results. Patients will be perfectly aware of how this therapy has been conceived and how it could impact and change their actual quality of life. They will also be informed of how the clinical trial has been designed and the consequences of participating in it. In addition, patients (and the general population) will tailor the project’s results dissemination and communication. This patient engagement will not be limited to the clinical trial but also to the rest of the activities of the project, so patients and the general society will be aware of how the research is developed and can include the patients’ point of view in the research activities. In addition, the socio-economic and psycho-social impact of the new treatment will also be analysed so that data on the benefits and impact of the new treatment will be obtained and made available to all the stakeholders.