Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Randomized, Double-Blind, Placebo-Controlled, Trial to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Orally Administered Capsid Inhibitors in HIV-1 Infected Treatment-Naïve Adults

This research is a Phase II clinical trial investigating a new oral medicine for adults who have recently been diagnosed with HIV and haven't started treatment yet. The main goal is to see how effectively the medicine, called a capsid inhibitor, lowers the amount of HIV in the blood over 11 days. Researchers also want to understand if the medicine is safe and well-tolerated, noting any side effects that might occur. They will also track how the body processes the medicine. This is an important step in finding new and potentially more effective ways to manage HIV infection.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Viiv Healthcare UK Limited

Enrolment target

Start

01 Dec 2023

HIV Infections

What is this study about?

This study is a clinical trial, which means it's a careful way of testing new medicines to see if they work and if they are safe for people. In this particular study, scientists are looking at new tablets for adults living with HIV. These are people who have been recently diagnosed and haven't yet started taking other HIV medicines.

The medicine being tested is called a 'capsid inhibitor'. Without getting too technical, this type of medicine works by stopping the HIV virus from building its protective shell, which makes it harder for the virus to multiply in the body. The tablets themselves are simple — white to off-white, oval, and smooth. Some people in the study will receive the active medicine, while others will receive a 'placebo', which looks identical but contains no active drug. This is a common way to properly test if the medicine itself is having an effect.

The main aim over the first 11 days of the study is to see how much the medicine can reduce the amount of HIV in a person's blood. The researchers will also be keeping a very close eye on any side effects, how severe they are, and if anyone needs to stop taking the medicine because of them. They'll also check liver function and how the body absorbs and uses the medicine. All of this information helps doctors understand if this new treatment could be a good option for people with HIV in the future.

Key takeaways

This study tests a new oral medicine (capsid inhibitor) for adults recently diagnosed with HIV.
It aims to see how well the medicine reduces the virus and if it's safe.
Participants will receive either the new medicine or a dummy pill (placebo).
Close monitoring, including blood tests, will track the virus and any side effects.
You must be an adult with HIV, not previously treated for it, to be eligible.
Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. Both men and women can take part. A key requirement is that you must have been recently diagnosed with HIV and not yet started any treatment for it. The study is specifically looking for people who are 'treatment-naive', meaning they haven't taken other HIV medicines before.

There might be other specific health checks or criteria that the study doctors will go through with you. These are to make sure the study is safe for you and that the results will be clear. For example, they might check your current health or other medicines you're taking.

It's important to discuss your full medical history with the study team. They will determine if you meet all the requirements. This ensures the safety of all participants and the quality of the research.

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 recently been diagnosed with HIV?
Have you *not* taken any HIV medicines before?
Are you able to take tablets by mouth?
Are you willing to attend regular clinic visits for checks and blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given tablets to take by mouth – either the new medicine or a placebo (a dummy pill). You won't know which one you're getting, and neither will the study doctors. You'll have regular visits to the clinic, especially in the first 11 days, for blood tests to check how the virus is responding and how your body is handling the medicine. These blood tests will help measure the amount of HIV in your blood and how much of the study drug is in your system. Doctors will also carefully monitor you for any side effects and check your overall health, including liver function, with further blood tests. The total duration of your participation, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial can have potential benefits. You might be among the first to receive a new medicine that could help manage your HIV. You'll also receive close medical attention and monitoring from a dedicated research team. However, there are also potential risks; the new medicine might have side effects that aren't yet fully known, or it might not work for you. The placebo also means you might not receive active treatment initially. All procedures, like blood tests, carry small risks. You will be given all the information about these risks and benefits before you decide to join, and remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (4)

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

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Unverified
Germany
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Unverified
Italy
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Unverified
Spain
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Unverified
France

Common questions

What is HIV?

HIV (Human Immunodeficiency Virus) is a virus that attacks the body's immune system. Without treatment, it can make it harder for your body to fight off infections and diseases.

What is a 'capsid inhibitor'?

It's a type of medicine designed to stop the HIV virus from making its protective outer shell, which helps prevent it from multiplying in your body.

What is a placebo?

A placebo is a tablet that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real medicine's effects.

Will I know if I'm getting the actual medicine or the placebo?

No, this study is 'double-blind,' meaning neither you nor the study doctors will know who gets the active medicine and who gets the placebo until the study is over.

How long will the study last?

While the main look at the virus's response is over 11 days, the total length of your participation, including follow-up, will be explained by the study team.