Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Randomized, Double-Blind (Sponsor-Unblinded), Placebo-Controlled, Adaptive Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in Treatment-Naïve Adults Living with HIV-1

This study, called "A Randomized, Double-Blind, Placebo-Controlled, Adaptive Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in Treatment-Naïve Adults Living with HIV-1", is designed to test a new medicine, VH3739937, for adults who have recently been diagnosed with HIV-1 and haven't started treatment yet. The main aim is to see how much the medicine can reduce the amount of the HIV virus in the blood over 8 days. We will also be carefully checking for any side effects and how the body handles the medicine. To make sure the results are fair, some participants will receive the actual medicine, while others will get a 'dummy' pill (placebo) that looks exactly the same but contains no active drug. Neither the participants nor most of the study staff will know who is getting which. This is an early-stage study, meaning it's one of the first times this medicine is being tested in people.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Viiv Healthcare UK Limited

Enrolment target

Start

12 Dec 2023

HIV Infections

What is this study about?

This study is looking into a new treatment for HIV, the virus that causes AIDS. The treatment is called VH3739937, and it's being tested for adults who have recently found out they have HIV-1 and haven't yet started any other HIV medicines. Think of it like a very early test drive for a new car – we're trying to understand how it works and if it's safe.

The main goal of this study is to see how effectively VH3739937 can reduce the amount of the HIV virus in a person's blood. We'll be doing blood tests over 8 days to measure this. We also want to understand if the medicine causes any side effects and how the body processes it. This information is really important because it helps scientists decide if the medicine is promising enough to be tested in larger groups of people in the future.

To make sure the results are as fair and accurate as possible, some participants will receive the actual VH3739937 medicine, while others will be given a placebo. A placebo is a tablet that looks identical to the actual medicine but doesn't contain any active drug. This helps us compare the effects of the active medicine against no treatment. Neither you nor most of the study doctors will know who is getting which tablet – this is called 'double-blinded' and helps prevent bias in the results.

Key takeaways

This study is testing a new, experimental medicine (VH3739937) for HIV.
It's for adults recently diagnosed with HIV-1 who haven't started treatment.
The main goal is to see how well the medicine reduces the virus and if it's safe.
Some participants will receive a dummy pill (placebo); neither you nor staff will know who gets what.
Participation involves taking daily tablets and attending regular clinic visits for blood tests and check-ups.
You can stop participating in the study at any time.

Who may be eligible?

This study is looking for volunteers who are adults, aged 18 years or older. There is no upper age limit.

To join, you must have been recently diagnosed with HIV-1 and, importantly, you must not have started any treatment for HIV yet. This is especially important as we want to see how this new medicine works on its own, without being affected by other HIV medications.

Both men and women can take part in this study. The study team will review your medical history and conduct some tests to make sure that taking part is safe and appropriate 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?
Have you NOT started any treatment for your HIV yet?
Are you able to attend clinic visits regularly?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given tablets to take by mouth. Some will contain the active medicine, and others will be a dummy pill (placebo). You will take these tablets once a day.

Throughout the study, you will have regular visits to the clinic, especially during the first 8 days, to have blood samples taken. These samples will help us measure the amount of virus in your blood and how your body is handling the medicine. We'll also be checking for any side effects.

The initial period of the study will last for 8 days, but there will likely be follow-up appointments after this to continue monitoring your health and the effects of the medicine. The research team will explain the full schedule of visits and tests during your first appointment.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you might receive access to a new medicine for HIV that could be effective in reducing the virus. However, as this is an early-stage study, we don't know for certain how well it will work or what side effects it might cause. There's also a chance you could receive a placebo, meaning you wouldn't get the active medicine during this part of the study. Possible risks include side effects from the medicine, or discomfort from blood tests. Your safety is our top priority, and you'll be closely monitored by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Poland
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Unverified
Italy
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Unverified
Greece
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Unverified
Spain

Common questions

What is HIV-1?

HIV-1 is the most common type of Human Immunodeficiency Virus, which can lead to AIDS if not treated. This virus attacks the body's immune system.

What does 'placebo-controlled' mean?

It means some people will get the actual new medicine, and others will get a 'dummy' pill that looks the same but contains no active drug. This helps us compare the real effects of the medicine.

Why is it important that I haven't started HIV treatment yet?

The study wants to see how this new medicine works on its own, without other HIV medications influencing the results. This helps us understand its specific effects.

How long will I be in the study?

The initial intense part of the study is for 8 days, with daily tablets and regular check-ups. There will likely be follow-up appointments after this period, and the team will explain the total duration.

Will I miss work or school if I join?

You will need to attend regular clinic visits, especially during the first 8 days, which may require time away from work or school. The study team can provide more details about the schedule.