AuthorisedTherapeutic exploratory (Phase II)Interventional

Phase II, Single-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial To Evaluate The Safety And Efficacy Of Dasatinib To Reduce HIV-1 Reservoir, Chronic Inflammation, And Immune Senescence In People With HIV On Long-Term Antiretroviral Treatment.

This clinical trial is designed for people living with HIV who are already on long-term antiretroviral therapy (HIV medication). The main goal is to explore whether a drug called dasatinib can help reduce the 'HIV reservoir' – which is hidden HIV in the body that current treatments can't get rid of. Researchers also want to see if dasatinib can lessen long-term inflammation and improve the health of the immune system, which can get tired over time in people with HIV. Participants will receive either dasatinib or a dummy pill (placebo) to compare their effects on immune cells and how well they are tolerated. The study is particularly interested in changes to different types of immune cells and markers of inflammation over several months.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Instituto De Salud Carlos III

Enrolment target

Start

08 Jun 2026

HIV-1 infection

What is this study about?

This study is looking into a new use for a medicine called dasatinib in people who have HIV. If you have HIV, you likely already take medicines to keep the virus under control. However, these medicines don't completely get rid of HIV; some of the virus can hide in certain cells in your body. This hidden virus is called the 'HIV reservoir'. This trial wants to see if dasatinib can reduce the amount of this hidden HIV.

Living with HIV, even when treated, can sometimes lead to ongoing inflammation in the body and cause the immune system to become 'tired' or age faster. This study also aims to find out if dasatinib can help calm this inflammation and make the immune system healthier and work better.

By carefully studying participants who take dasatinib compared to those who take a dummy pill (a placebo), the researchers hope to learn if dasatinib is safe and effective in tackling these long-term challenges for people living with HIV. This could potentially lead to better health outcomes in the future.

Key takeaways

This study evaluates a drug called dasatinib for adults with HIV already on long-term treatment.
It aims to see if dasatinib can reduce hidden HIV, calm inflammation, and improve immune health.
Participants will receive either dasatinib or a placebo (dummy pill).
Close monitoring of immune cells, inflammation, and potential side effects will occur over about a year.
The study seeks to understand long-term benefits beyond current HIV treatment.
Patient safety is a top priority, with regular health checks during participation.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old. Both men and women are welcome to participate.

Crucially, you must have HIV and already be taking your regular HIV medication (antiretroviral treatment) for a long time. The study is specifically for those who have been on stable HIV treatment.

Unfortunately, the study doesn't mention specific reasons why someone might *not* be able to join, such as other serious health conditions or medications you might be taking. If you're interested, your doctor will be able to check all the detailed 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.

Are you 18 years old or older?
Do you have HIV?
Are you currently taking long-term, stable HIV medication (antiretroviral treatment)?
Are you willing to attend regular clinic visits and have blood tests for about a year?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the study drug, dasatinib, or a placebo (a dummy pill that looks like the drug but has no active ingredients). You won't know which one you're taking, and neither will your study doctor. This is done to make sure the results are fair.

You will need to attend several clinic visits over a period of about a year (48 weeks). During these visits, the research team will take blood samples to check your immune cells and other markers. They will also ask about any side effects you might be experiencing. The study will involve checks within the first few days of starting treatment, and then at 4, 12, 24, 28, 36, and 48 weeks. Your health and safety will be monitored closely throughout the study.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as gaining access to a new treatment before it's widely available and receiving close medical monitoring. However, there are also potential risks; the study drug may cause side effects, some of which could be serious, or it might not work for you. You will be told about all known risks before you decide to join. Remember, participation is completely voluntary, 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
Spain

Common questions

What is the 'HIV reservoir'?

The HIV reservoir refers to a small amount of HIV that hides in certain cells of the body. Current HIV medicines can control the virus but can't completely get rid of this hidden HIV.

What does 'chronic inflammation' mean for people with HIV?

Even with treatment, people with HIV can sometimes have ongoing inflammation in their body, which means their immune system is constantly slightly activated. This can contribute to other health problems over time.

What is 'immune senescence'?

Immune senescence refers to the immune system becoming 'tired' or aging faster, which can happen in people living with HIV. This can make it harder for the body to fight off infections or respond to vaccines.

What is a 'placebo'?

A placebo is a dummy pill that looks like the study drug but doesn't contain any active medicine. It helps researchers compare the effects of the real drug fairly.

How long will I be in the study?

The active part of the study involves visits and taking medication over a period of about 48 weeks, which is roughly 11 months.