Evaluating a Combination of Immune-based Therapies to achieve a Functional Cure of HIV infection

Study Objective

Currently, over 36 million people worldwide are infected with HIV, most of them living in developing countries. 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.

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.

Source : study website: http://www.hivacar.org
 

Participation conditions

1. ≥ 18 years of age

2. Voluntarily signed informed consent

3. Proven HIV-1 infection (with documented antibodies against HIV-1 and a detectable plasma HIV-1 RNA before initiation of therapy)

4. On stable treatment with cART regimen (antiretroviral therapy consisting of at least three registered antiretroviral agents) for at least 3 years

5. Nadir CD4+ ≥ 350 cells/μl (up to 2 occasional determinations ≤ 350 cells/μl are allowed)

6. Current CD4+ cell count ≥ 450 cells/μl

7. HIV-RNA below 50 copies/mL in the last 6 months prior to randomization, during at least two measurements (occasional so called 'blips' ≤ 500 copies/mL are permitted)

For more details please contact study center

This Project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 731626

Universiteit Ziekenhuis Brussel (UZ Brussel) – Belgium (Prof Dr Sabine Allard)