Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

An Open-Label, Multi-Centre, Randomised Study to Investigate Integrase Inhibitor Versus Boosted Protease Inhibitor Antiretroviral Therapy for Patients with Advanced HIV Disease -The Late Presenter Treatment Optimisation Study (LAPTOP)-

The LAPTOP study is looking into the best ways to treat people who are diagnosed with HIV when their immune system is already quite weakened. It's comparing two types of powerful anti-HIV medications: ones that include an 'integrase inhibitor' (like Biktarvy) and others that use a 'boosted protease inhibitor' (like Symtuza). Researchers want to see which treatment best controls the virus and helps people get healthier. They'll be checking how long treatments work, how much the virus reduces, and whether people's immune cells recover. The study also investigates side effects and overall quality of life to recommend the most effective and safest options for patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

NEAT ID Foundation

Enrolment target

357

Start

02 Nov 2023

Patients who present late on during their acquisition of the HIV-1 (Human Immunodeficiency Virus)

What is this study about?

This study, called LAPTOP (Late Presenter Treatment Optimisation), is all about finding the best combination of medicines for people who are diagnosed with HIV at a later stage, meaning their immune system has been affected for some time. When someone is diagnosed late, they often need help to get their health back on track quickly and effectively. This study aims to figure out which modern HIV therapies work best in these situations.

Researchers are comparing two main types of anti-HIV treatments. One group of patients will receive a medicine called Symtuza, which contains different drugs, including a 'boosted protease inhibitor.' Another group will receive Biktarvy, which includes a type of drug called an 'integrase inhibitor.' Both Biktarvy and Symtuza are 'film-coated tablets', which are just a fancy way of saying they are regular tablets with a coating. The study is designed to see if one approach is better than the other at controlling the HIV virus, helping the immune system recover, and improving general health.

This is a 'Phase 3' study, which means these treatments have already been tested and shown to be safe and promising in earlier stages. Now, the goal is to confirm their effectiveness against each other and gather more detailed information on how they perform in a larger group of people. The ultimate aim is to improve the lives of people living with HIV, especially those who come to medical attention later in their illness.

Key takeaways

Compares two leading HIV treatment approaches for people diagnosed with advanced HIV.
Aims to find the most effective and safest therapy.
Involves taking either Symtuza or Biktarvy tablets.
Requires regular medical check-ups and blood tests over 48 weeks.
You will receive close medical supervision throughout the study.
Participation could offer access to cutting-edge HIV care.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. The study is open to both men and women.

Crucially, you would need to be in a situation where you have been diagnosed with HIV-1, and your immune system is already quite weakened. This specific aspect of your health would be determined by a doctor based on your medical tests.

There might be other health conditions or medications that would prevent you from taking part, but these will be discussed in detail by the study doctor to make sure it's safe for you.

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 been diagnosed with HIV-1?
Has your doctor told you that your immune system is significantly weakened due to HIV?
Are you able to attend regular clinic appointments for about a year?

Answer every question to see your result.

What does participation involve?

If you join the study, you would be randomly assigned to receive one of the two different treatment combinations: either Symtuza or Biktarvy. You would take this medication as prescribed by the study doctors.

Your health would be closely monitored with regular visits to the clinic. During these visits, you would have blood tests to check your HIV levels (how much virus is in your blood), your immune cell counts (CD4 cells), and to make sure the medication isn't causing any problems. Doctors would also ask about any symptoms or side effects you might be experiencing. These check-ups would happen at specific times, such as at weeks 4, 8, 12, 24, 36, and 48 after starting the treatment.

The study also involves tracking your overall well-being, including how you feel, your quality of life, and any hospital visits or emergency room trips. The total duration of active study participation involving regular assessments would be for 48 weeks (around 11-12 months). After this, your doctors would continue to manage your care.

Potential risks and benefits

Taking part in this study could potentially offer you access to modern and effective HIV treatments, with very close medical monitoring, which could lead to better control of your HIV and an improved immune system. As with all medications, there's a chance of side effects, ranging from minor to more serious, which doctors will discuss with you. There's also a possibility that the treatment might not work as well for you as expected, or that you could develop resistance to the drugs. You have the full right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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

—
Unverified
Spain
—
Unverified
Ireland
—
Unverified
Italy
—
Unverified
Belgium
—
Unverified
Germany
—
Unverified
France

Common questions

What does 'late presenter' mean in this study?

It means you were diagnosed with HIV when your immune system had already become significantly weakened, as determined by your doctors.

Are the treatments in this study new or experimental?

These are current, modern HIV medications that are already approved for use. This study is comparing them to see which works best for people diagnosed late.

Will I know which treatment I'm receiving?

Yes, this is an 'open-label' study, which means both you and your doctor will know which medication you are assigned to.

What is 'virological failure'?

This term means the HIV virus is not being controlled effectively by the medication, and the amount of virus in your blood isn't decreasing as expected.

How long will I be on the study medication?

The main study follow-up period for tracking results is 48 weeks (about 11 months). Your doctor will discuss ongoing treatment plans after that.