Active not recruitingPHASE1INTERVENTIONAL

A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV

This research trial is investigating new approaches to reduce the 'viral reservoir' in people living with HIV. The viral reservoir refers to the hidden HIV that remains in the body even when standard treatments are working. The study is testing a new medication, VH3810109, by itself or combined with an existing drug called Fostemsavir (FTR). Participants will include two groups of adults: those who have recently been diagnosed with HIV and haven't started treatment yet, and those who have been on stable HIV treatment for a while and are doing well. The aim is to see if these new approaches can help further reduce the amount and activity of the hidden virus.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

ViiV Healthcare

Enrolment target

107

Start

10 Jul 2025

Estimated completion

06 Sep 2028

HIV Infections

What is this study about?

This study is designed to explore new ways of tackling HIV, specifically focusing on what doctors call the 'viral reservoir'. Even with very effective current HIV treatments, some of the virus remains hidden in certain cells in the body. This hidden virus is why people with HIV need to take medication continuously, as it can reactivate if treatment stops.

The main goal of this trial is to see if a new drug, called VH3810109, either alone or with another drug already in use for HIV (Fostemsavir), can help reduce the amount of this hidden HIV, or make it less active. If successful, this could be a big step forward in managing HIV.

The study includes two different groups of adults living with HIV. One group consists of people who are new to HIV treatment, meaning they haven't taken any HIV medicines before. The second group includes people who have been on standard HIV treatment for a long time, are doing well, and have very low levels of the virus in their blood. By studying both groups, researchers hope to understand how these new approaches might work in different situations.

Key takeaways

New study exploring ways to reduce hidden HIV in the body.
Tests a new drug (VH3810109) with or without an existing HIV drug.
Open to recently diagnosed individuals and those on stable treatment.
Goal is to decrease the amount and activity of the viral reservoir.
Participation involves clinic visits, blood tests, and taking study medication.
Voluntary participation with the right to withdraw at any time.

Who may be eligible?

To join this study, participants must be between 18 and 70 years old. You can be of any gender identity, but if you are able to become pregnant, you must not be pregnant or breastfeeding, and agree to use effective contraception throughout the study.

There are two main groups in this study. If you have been recently diagnosed with HIV and have not yet started any HIV treatment, your blood tests should show a certain level of HIV virus and your immune cell count (CD4) should be at a specific level. If you have been living with HIV for a while and are already on stable HIV treatment (specifically an INSTI-based regimen) for at least six months, and have had undetectable virus levels for a prolonged period, your immune cell count (CD4) also needs to be at a certain level, and your body weight must be between 50 kg and 115 kg.

You cannot join if you are pregnant or breastfeeding, or if you have HIV-2. You also can't participate if you have certain past or current serious health conditions, such as some cancers or severe illnesses related to HIV that have progressed to a late stage. The researchers will discuss all these criteria with you to ensure your safety and suitability for the study.

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 between 18 and 70 years old?
Are you living with HIV?
If you can become pregnant, are you not pregnant or breastfeeding and willing to use contraception?
If newly diagnosed, have you not started HIV treatment yet?
If already on treatment, have you been on stable HIV treatment (especially an INSTI-based one) for at least 6 months with undetectable virus?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve a number of visits to the clinic over a period of time. During these visits, you would have blood tests, physical examinations, and other health checks to monitor your progress and well-being. You would be given the study medication, VH3810109 (and potentially Fostemsavir), to take as directed. The study medications are taken in pill form. You would also receive support and guidance from the study team throughout your participation. The total duration of the study, including follow-up, will be explained in detail by the research team. At any point, you have the right to withdraw from the study without giving a reason.

Potential risks and benefits

Participating in this study might offer the potential benefit of accessing new HIV treatments that could help reduce your viral reservoir, possibly leading to better long-term health outcomes. However, as with any new medication, there may be side effects or risks that are currently unknown or that differ from standard treatments. These will be carefully monitored by the study team, and you will be fully informed of all known risks before you decide to participate. Remember, your participation is completely voluntary, and you have the right to leave the study at any time, for any reason, without affecting your regular medical care.

Locations (41)

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

GSK Investigational Site
Verified postcode
Bakersfield, United States
GSK Investigational Site
Verified postcode
San Diego, United States
GSK Investigational Site
Verified postcode
Ft. Pierce, United States
GSK Investigational Site
Verified postcode
Orlando, United States
GSK Investigational Site
Verified postcode
Chicago, United States
GSK Investigational Site
Verified postcode
Kansas City, United States
GSK Investigational Site
Verified postcode
St Louis, United States
GSK Investigational Site
Verified postcode
New York, United States
GSK Investigational Site
Verified postcode
Cincinnati, United States
GSK Investigational Site
Verified postcode
Philadelphia, United States
GSK Investigational Site
Verified postcode
Pittsburgh, United States
GSK Investigational Site
Verified postcode
Dallas, United States

Common questions

What is a 'viral reservoir' in HIV?

The viral reservoir refers to hidden HIV that stays in certain cells in your body even when standard treatments keep the virus in your blood very low. It's why people with HIV need continuous treatment.

What does 'treatment-naïve' mean?

This means you have recently been diagnosed with HIV and have not yet started taking any HIV medications.

What is an INSTI-based ART regimen?

This is a type of standard HIV treatment that uses a specific class of drugs called integrase strand transfer inhibitors, which are very effective at controlling the virus.

Will I know if I'm getting VH3810109 or the combination?

In some parts of the study, participants might receive VH3810109 on its own or with another drug called Fostemsavir. The study design will be fully explained to you before you agree to participate.

Can I stop my regular HIV medication if I join this study?

No, if you are already on HIV treatment, you would continue your current stable regimen, and the study medication would likely be added to it. Do not stop any prescribed medication without discussing it with the study team and your usual doctor.