HIVACAR – Evaluating a Combination of Immune-Based Therapies to Achieve a Functional Cure of HIV Infection

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Why?

Currently, over 36 million people worldwide are infected with HIV, most of them living in developing countries1. In 2014, 1.2 million people died of AIDS-related illnesses. Combined antiretroviral therapy (cART) has proven to be highly effective to prevent clinical progression and death, but HIV-1 infection is considered a chronic disease and antiretroviral treatment on its own is unable to eradicate the infection. The patients hence necessitate therapy throughout their lives. Moreover, viral resistance development, adverse effects in the medium-long term, and its significant cost are important limitations for lifelong adherence to antiretroviral treatment and for widespread use mainly in developing countries, but also in the developed world. Therefore, for an effective control of the HIV epidemic new cost-effective and viable therapeutic strategies need to be evaluated. A safe, affordable and scalable cure could address both the individual and public health limitations that are associated with lifelong cART.

 

What?

HIVACAR aims to provide a new therapeutic alternative to “cART for life” (combined antiretroviral therapy) and will address the individual and public health limitations associated with this standard of care:

  • Cost of the medication.
  • Mandatory high adherence to medication for life.
  • Side effects.
  • Risk of resistances development.

An innovative strategy based on the patient’s immune system, safe, affordable and scalable to achieve the functional cure of HIV-1 infection will be tested in a Phase I / IIa clinical trial. In addition, the ethical, economic and psychosocial challenges associated with a functional HIV cure will be investigated to provide a complementary alternative to the current treatment standard.

 

With whom?

You can find the project partners here.

 

How?

The project has been divided into seven Work Packages that will lead to the achievement of the ambitious goals of HIVACAR:

  1.  Scientific coordination and project management
  2.  Design of a personalized mRNA vaccine
  3.  Clinical Trial Management and Development
  4. Clinical Trial Phase IIa implementation
  5.  Data Analysis
  6. Socio Economic and Psycho-Social Impact and Patient Engagement
  7. Dissemination and exploitation

EATG is co-leading with the Complutense University of Madrid (UCM), the research on economical and psychosocial challenges associated with a functional HIV. The project takes in account the view of the patient for the design of the clinical trial, the ethical problems raised by a functional cure or the generation of false and high expectations but also the socio-economic consequences of the new approach compared with the traditional therapies. EATG is ensuring the real participation and engagement of patients and other stakeholders. EATG is also involved in the dissemination and communication of the project, the research and the concept to HIV community, policy makers and the general public in Europe.

 

Involvement of EATG: Leaders for WP6 (Socio-Economic and Psycho-Social Impact and Patient Engagement); Contribution for WP4: Clinical Trial phase I/lla Implementation and WP7: Dissemination and Exploitation

 

For what outcome?

The main goal of HIVACAR is to change the current paradigm of HIV treatment by obtaining a functional cure for HIV 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. 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.

 

EATG contact person(s):Giorgio Barbareschi – giorgio.barbareschi@eatg.org
Duration of the project/initiative:January 2017 – Summer 2022
Project/Initiative Leader:Consorci Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain
Project/initiative Main Partner(s):eTHERNA NV (eTheRNA), Belgium, Fundació Privada Institut de Recerca de La Sida-Caixa (IRSICAIXA), Spain, Aarhus University Hospital Skejby, Denmark Institute of Clinical Medicine, Aarhus University (AARHUS), Denmark, Vrije Universiteit Brussel (VUB), Belgium, Laboratory of Molecular Immunology, The Rockefeller University (LMI), US, Centro Nacional de Biotecnología, CSIC (CNB), Spain, Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia Centre for Excellence in HIV/AIDS (SFU), Canada, EATG, Facultad de Ciencias Económicas y Empresariales. Universidad Complutense de Madrid (UCM), Spain, European Clinical Research Infrastructure Network- European Clinical Research Consortium (ECRIN-ERIC), France, Asphalion, S.L. (ASPHALION), Spain, Assistance Publique Hôpitaux de Paris (APHP), France, Zabala Innovation Consulting, S.A (ZABALA), Spain, Aelix Therapeutics, S.L. (AELIX), Spain
Budget:Total: 6.685.111 € / EATG: 150.000 €
Main Funding Sources:The European Commission – Horizon 2020 (Call H2020-SC1-2016-RTD)
Links:http://www.hivacar.org/
Communication Disclaimer:This Project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 731626

 

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