AuthorisedTherapeutic use (Phase IV)Interventional

CLINIC-CURE, a pilot exploratory clinical trial of analytical treatment interruption in people with HIV with a highly favorable profile

Modern HIV treatments work brilliantly to keep the virus suppressed, but people usually need to take tablets every day for life. The CLINIC-CURE trial is exploring whether some people with HIV can pause their medication safely under close medical watch. Researchers are looking for adults who have a 'highly favourable' immune profile, meaning their body shows strong signs of being able to fight the virus naturally. Participants will temporarily stop their regular combination therapy. Doctors will monitor them with frequent blood tests over 24 weeks to see if the virus remains at undetectable levels (below 50 copies). If the virus begins to rise, standard medication will be restarted straight away. The goal is to learn how natural immune control works, helping scientists move closer towards an eventual cure for HIV.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Enrolment target

Start

06 Aug 2026

HIV

What is this study about?

Today, HIV is a manageable long-term condition thanks to modern antiretroviral tablets. These medicines stop HIV from multiplying, reducing it to undetectable levels in the blood. When the virus is undetectable, it cannot damage the immune system or be passed on to sexual partners. However, the virus stays hidden in a dormant state inside the body, which is why treatment usually has to continue for life.

Scientists have observed that a small number of people seem to have immune systems capable of keeping HIV asleep even without tablets. The CLINIC-CURE study is an exploratory trial designed to investigate this. It focuses on individuals whose immune markers suggest they might have natural control over the virus.

During the study, volunteers will undergo an 'analytical treatment interruption'—a planned, temporary pause of their daily HIV medication. The medical team will check their blood regularly to see if the virus stays below 50 copies per millilitre for 24 weeks, and to study how their natural defence cells react.

Participant safety is the highest priority throughout. If blood tests show that the virus is waking up, treatment is restarted immediately to protect the immune system. By studying the blood of participants before, during, and after this treatment pause, researchers hope to uncover valuable clues that could guide the development of future HIV cures.

Key takeaways

CLINIC-CURE is investigating whether selected people with HIV can pause medication safely.
The study involves a planned 24-week pause in treatment under very close medical supervision.
Only people with specific, strong immune profiles are eligible to take part.
If the virus rebounds at any point, regular HIV treatment is restarted immediately.
Taking part is voluntary, and participants can restart their medication at any time.

Who may be eligible?

This trial is designed for adults aged 18 and older who are living with HIV and currently taking standard triple-therapy medication (such as bictegravir, emtricitabine, and tenofovir alafenamide). Participants must have had a stable, undetectable viral load for a sustained period.

Because stopping medication involves careful management, this study is only open to people with a 'highly favourable' immune system profile. This means your blood must show specific immune features, such as very low levels of hidden virus and strong natural killer cell activity, which suggest your body might keep the virus under control on its own.

People who have other serious health conditions, a weakened immune system, or who do not match these specific biological markers will not be able to take part. Your HIV specialist would need to perform specialised laboratory tests to see if your immune profile matches the trial's requirements.

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.

I am aged 18 or older.
I am living with HIV and currently taking daily antiretroviral medication.
My viral load has been undetectable for a long time.
I am willing to attend frequent hospital visits for blood tests.
I am comfortable temporarily pausing my medication under strict doctor supervision.

Answer every question to see your result.

What does participation involve?

Taking part lasts for around 48 weeks (just under a year). You will be asked to pause your daily HIV tablets while staying under close medical observation. In the first few months after stopping treatment, you will need to attend the clinic frequently for blood tests to measure your viral load and check your CD4 immune cells. If your viral load rises above a safe threshold, or if you feel unwell, you will restart your regular medication immediately. Throughout the trial, you will have regular check-ups, health reviews, and follow-up appointments to ensure your long-term health remains fully protected.

Potential risks and benefits

Taking part does not guarantee any personal medical benefit, though it offers an opportunity to contribute to vital research that could help find a cure for HIV. The primary risk is that pausing treatment can cause the virus to rebound, which may temporarily lower your immune defences, cause mild flu-like symptoms, or increase the risk of passing the virus to partners. To minimise these risks, your blood will be monitored very frequently and treatment will be restarted at the first sign of viral activity. Joining the study is completely voluntary, and you have the right to withdraw and restart your tablets at any time without your normal NHS care being affected.

Locations (1)

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

—
Unverified
Spain

Common questions

Why are doctors asking participants to stop taking their medication?

Pausing medication in a controlled setting is currently the only way to see if a person's immune system can keep HIV suppressed on its own, providing key clues for future cure research.

What happens if my viral load starts to go up?

Your viral load will be checked very frequently. If it rises above the safety cut-off, your doctors will restart your standard HIV treatment straight away to bring it back under control.

Can I pass HIV to my partner during the study?

Yes, there is a risk. Because you are pausing treatment, your viral load could rise, meaning the 'Undetectable = Untransmittable' (U=U) principle cannot be guaranteed. You would need to use barrier protection, such as condoms.

How often will I need to have blood tests?

You will need regular clinic visits and blood tests, especially in the first weeks after stopping your tablets, so doctors can spot any changes in viral levels immediately.

Can I leave the study if I feel uncomfortable?

Yes. You can withdraw from the study at any time, for any reason, and go back onto your normal HIV treatment without it affecting your ongoing care.