Community

This will be a pivotal study involving people living with HIV with specific characteristics. By “pivotal” we mean that, since this therapeutic intervention has not been studied before, the trial will only involve few participants and will take into particular consideration all the issues related to the participants’ safety.

The therapeutic intervention that the trial will investigate is an immune-based strategy. “Immune-based” means that this will involve treatments aimed at improving the response of participants’ immune system against HIV.

The immune-based strategy investigated in the HIVACAR trial will be a combination of these three treatments:

1. A therapeutic vaccine: this is a compound that is supposed to stimulate immune-system, helping it fight against HIV. A stronger immune response should be able to avoid spread of HIV infection in the body. The HIVACAR study will compare two different therapeutic vaccines.
2. A broadly neutralizing antibody: antibodies are part of the immune system and they fight against infectious agents. This antibody is called “broadly neutralising” because it is supposed to stop the replication of several types of HIV, since a single person can be infected with many different variants of the virus.
3. A latency reversing agent: HIV hides inactive in some cells; these cells do not look like the cells infected with an active HIV and therefore are not recognised by the immune system or antiretroviral drugs. In order to get rid of that inactive HIV, it should be “waken up” from its latent status. This compound is called “latency reversing agent” because it is supposed to reactivate HIV from its latent status.

Participants in the clinical study and the community of PLHIV at large will be asked to answer a questionnaire designed to investigate:

1. How much they know about the risks and the benefits of taking part to a clinical study investigating a strategy to control HIV infection without taking medicines every day, and how they think information about this should be given.
2. How they think their lives would be changed if they could be able to control HIV infection without taking medicines, and if this would impact also how they take care of their health.
3. How they think society as a large could change the way people living with HIV are looked at if they could control the virus without taking medications.

Alongside this survey, another analysis will investigate how economic resources could be allocated differently if HIV infection could be controlled without medications.