RecruitingPhase IVInterventional

A study looking at using two drugs as dual anti-HIV therapy in people who have previously had brain injury caused by HIV

This study is investigating a two-drug HIV treatment called Dovato. It's for people living with HIV who have previously had problems with their brain health because of the virus, but are now stable. Traditionally, HIV treatment uses three drugs, but newer, more effective medications mean two-drug combinations are now recommended. Switching from three drugs to two might lead to fewer side effects. The study wants to find out how safe and effective Dovato is for this specific group of people, and if it continues to control the virus and keep their brain health stable. The findings could help improve future care for people with HIV.

At a glance

Status

Recruiting

Phase

Phase IV

Sponsor

Imperial College London

Enrolment target

Start

01 Oct 2025

Estimated completion

15 Jun 2026

HIV infection

What is this study about?

You might be seeing this information because you or someone you know is living with HIV. We know that living with HIV can be complicated, and sometimes the virus can affect different parts of the body, including the brain. In the past, if the HIV virus wasn't fully controlled, it could cause damage to the brain, which doctors call HIV-associated brain injury (or HABI). While modern HIV medicines are very good at stopping the virus from causing new damage, the effects of past injury can sometimes remain.

This study is looking at a new way to treat HIV in people who have experienced this past brain injury, but where the virus is now well-controlled and not causing any new brain problems. Historically, HIV treatment involved taking three different medications together every day. However, new medications are much more powerful, meaning it might be possible to control the virus effectively with just two drugs. This two-drug therapy is called Dovato, which combines dolutegravir and lamivudine.

The main goal of this study is to see if changing from a three-drug treatment to a two-drug treatment like Dovato is safe and effective for people who have had HIV-related brain issues in the past. Researchers want to ensure that switching to fewer medications continues to keep the virus under control and maintains your brain health. The information gathered from this study could help doctors decide on the best treatment options for similar patients in the future.

Key takeaways

This study evaluates a two-drug HIV treatment (Dovato) for people with past HIV-related brain issues.
It aims to see if Dovato is safe and effective in this specific group, as switching to fewer drugs might reduce side effects.
Participation involves regular clinic visits, blood tests, brain function tests, lumbar punctures, and MRI scans over two years.
There are no direct personal benefits, but findings could improve future HIV care.
Careful monitoring will ensure the treatment keeps your HIV controlled.
Women who can become pregnant must use effective contraception due to potential risks to an unborn child.

Who may be eligible?

For this study, we're looking for adults aged 18 and over who are living with HIV. A key part of joining is that at some point in the past, your HIV must have affected your brain health. However, at the time of joining the study, there should be no sign that the virus is currently harming your brain.

To take part, you must currently be taking a three-drug HIV treatment and have never tried a two-drug treatment before. Your HIV should be well-controlled with your current medication. If you are female and able to become pregnant, you will need to take a pregnancy test and use very reliable birth control throughout the study to protect any unborn child, as the study drugs might not be safe during pregnancy.

We would not be able to include you if you've recently had signs of HIV activity in your brain or spinal fluid, or if the virus has shown resistance to HIV drugs in the past. This study aims to ensure the new treatment is safe for a specific group of people.

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?
Have you ever had HIV affect your brain health in the past?
Are you currently on a three-drug HIV treatment?
Have you *never* taken a two-drug HIV treatment before?
If you can get pregnant, are you willing to use very reliable birth control throughout the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll need to attend at least 11 appointments over about two years. Most of these will be at your regular clinic. During these visits, you'll fill out some questionnaires, do some simple brain exercises (cognitive tests), and have blood samples taken.

You will also have at least two lumbar punctures, sometimes called a spinal tap. This is where a small amount of fluid is taken from around your spine. Additionally, you will have two brain scans (MRI scans) at a different location specializing in imaging.

At the beginning of the study, your HIV treatment will be switched from your current three-drug therapy to the two-drug Dovato. You might switch back to a different treatment at the end, if recommended by the study team. Throughout the study, the team will closely monitor you to make sure your new treatment is working effectively.

Potential risks and benefits

There are no direct personal benefits for participating in this study. However, the information we learn could help improve future treatments for other people living with HIV, especially those who have experienced past brain health issues due to HIV. There are some potential risks. The most common side effect after a lumbar puncture is a headache, which can affect 1 to 3 out of every 10 people. This headache usually gets worse when you sit or stand up. Other temporary effects can include nausea or dizziness. Rarely, a more involved procedure called a 'blood patch' might be needed to stop a fluid leak. Taking blood samples can cause slight discomfort, bruising, or feeling faint. You will be switching your HIV medication, which is generally safe, but there's always a small chance that changing treatments could lead to unexpected issues. The study team will closely monitor you for this. If you are a woman who could become pregnant, it's very important to use effective birth control throughout the study, as the drugs could harm an unborn baby. You have the right to withdraw from the study at any time.

Locations (3)

St Mary's Hospital
Approximate
London, England
Royal Sussex County Hospital
Approximate
Brighton, England
Royal London Hospital
Approximate
London, England

Common questions

What is 'legacy HABI'?

Legacy HABI means you've had problems with your brain health in the past because of HIV, but the virus is no longer actively damaging your brain now.

What is Dovato?

Dovato is a combination of two medicines, dolutegravir and lamivudine, used as a powerful two-drug treatment for HIV.

Why is this study important if two-drug therapies are already recommended?

This study specifically looks at whether this two-drug therapy is safe and effective for people who have *previously* had HIV-related brain issues, which hasn't been studied fully before.

Will I have to pay for anything if I take part?

No, all study-related visits, tests, and medications will be provided as part of the research.

What if I get pregnant during the study?

If you are a woman who could get pregnant, you must use highly effective birth control. If you become pregnant, you must tell the study team immediately as you would need to stop the study treatment.

How to find out more

Nicki Doyle

n.doyle@imperial.ac.uk +44 (0)20 7594 3351 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.