Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

The Italian Cohort (ITACO) and the Analytical Antiretroviral Treatment Interruption Italian Cohort (ITACO-ATI) study guided by molecular HIV-1 reservoir profiling

This research is for people who were born with HIV. The study has two main parts. The first part, ITACO, aims to understand more about how the HIV virus 'hides' silently in the body. Researchers are looking for specific signs in blood cells that might tell them if the virus is truly inactive, which they call 'PredictHIV negative'. The second part, ITACO-ATI, focuses on a small group of these 'PredictHIV negative' individuals who, under strict medical supervision, temporarily stop their usual HIV medication. This is to see how long it takes for the virus to become detectable again, or if it stays hidden. They are also looking at how safe this process is. This study could help us learn if some people with HIV might someday be able to stop daily medication.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Ospedale Pediatrico Bambino Gesu

Enrolment target

Start

31 Jan 2025

perinatally HIV infection

What is this study about?

This important study, named 'ITACO' and 'ITACO-ATI', is currently underway to learn more about HIV in people who have had the condition since birth. HIV medicine has come a long way, and many people live healthy lives with it, but stopping daily medication safely is a big goal for researchers. This study aims to get us closer to that.

The first part, ITACO, is like detectives looking for hidden clues. Scientists are carefully examining blood samples to find tiny pieces of HIV that are tucked away in a quiet part of your cells. They are trying to identify a special type of HIV absence they call 'PredictHIV negative'. This means the virus might be hidden in a way that makes it very unlikely to cause problems.

For the second part, ITACO-ATI, a small group of volunteers who are identified as 'PredictHIV negative' will take part in a carefully supervised break from their regular HIV medication. This is called an 'analytical treatment interruption' (ATI). During this time, doctors will watch them very closely to see what happens. They want to understand if the virus stays hidden, how long it takes for it to become detectable again, and if this process is safe. The ultimate goal is to find out if, for some people, stopping long-term HIV medication could become a safe option in the future. It's really important to remember that this is done under extremely strict medical supervision in a research setting, and nobody should stop their HIV medicine without their doctor's guidance.

Key takeaways

This study focuses on people who have had HIV since birth.
It aims to understand how HIV hides in the body and if safely stopping medication is possible.
Participation involves blood tests and close medical monitoring.
A small number of participants might temporarily stop medication under strict supervision.
The study could lead to new ways to manage HIV in the future.

Who may be eligible?

This study is looking for adults aged 18 or older. Both men and women are welcome to take part.

Specifically, the main requirement is that you were born with HIV. This means you have a type of HIV called 'perinatally HIV infection'.

There might be other health checks or requirements that the study doctors will go through with you to make sure it's safe for you to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Were you diagnosed with HIV that you got at birth?
Are you able to attend appointments and give blood samples?
Are you willing to potentially have your HIV medicine paused under strict medical guidance (if applicable for ATI part)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have some health checks to make sure the study is right for you. This will involve giving blood samples so researchers can look for specific signs of the HIV virus in your cells. You might return for further blood tests over time, and possibly undergo other assessments to track your health.

For some participants in the second part of the study (ITACO-ATI), there will be a period where medication might be temporarily stopped under very close medical supervision. This would involve frequent clinic visits and blood tests to monitor your viral load and overall health. You would return to your HIV medicine if the virus becomes detectable again or if other health concerns arise. The total duration of participation would be discussed with you by the study team, as it varies depending on which part of the study you are involved in.

Potential risks and benefits

Potential benefits of joining include contributing valuable knowledge that could help future generations of people with HIV, and getting very close medical monitoring of your condition. However, there are potential risks, especially for those who might temporarily stop medication in the ATI part of the study. The virus could become detectable again, and you would need to restart your medication. It's also possible to experience side effects from any procedures or tests. Your health and safety are the top priority, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What does 'perinatally HIV infection' mean?

It means you were born with HIV, meaning you got it from your mother during pregnancy, birth, or through breastfeeding.

Why are researchers looking at cells from blood?

They are looking for bits of the HIV virus hidden deep inside certain blood cells to understand how it 'sleeps' in the body.

Can I stop my HIV medicine if I join this study?

Only a small, very specific group of participants in one part of the study might temporarily stop their medicine, and this is done under extremely close medical supervision. You should never stop your medication without talking to your doctor first.

What is 'PredictHIV negative'?

It's a special term in this study meaning researchers can't find certain active parts of the HIV virus hidden in specific places in your cells.

Will I have to pay to be part of this study?

No, you should not have to pay to participate in a clinical trial. All study-related tests and medications would be provided by the research team.