RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

This study is for people in the UK living with HIV. We are looking into a new long-acting (meaning you don't take it every day) treatment called Cabotegravir (CAB) + Rilpivirine (RPV) for those whose current daily oral HIV medicine isn't keeping the virus fully under control. The main goals are to see how effective this new injection-based treatment is at lowering the amount of HIV in the blood and how safe it is over time. We also want to understand what it's like for patients to use this new treatment based on their experiences. This is a Phase 3 study, which means it’s one of the final steps before a medicine might become widely available.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

ViiV Healthcare

Enrolment target

332

Start

02 Dec 2024

Estimated completion

18 Aug 2028

HIV Infections

What is this study about?

Imagine you're managing HIV, and even though you've been taking your daily pills, the virus levels in your blood are still a bit higher than doctors would like. This study is exploring a new approach for people in that very situation. Instead of daily pills, this trial is testing a long-acting treatment, which means you receive injections less frequently.

The specific medicines being tested together are called Cabotegravir (CAB) and Rilpivirine (RPV). The study aims to find out if this long-acting combination is effective at bringing down the amount of HIV in the blood to very low levels, and if it's generally safe for people to use. It's a key step in understanding if this new method could be a good option for future HIV treatment.

Beyond just the numbers and safety data, the study also places importance on patient feedback. Your experiences and thoughts about receiving and living with this long-acting treatment are incredibly valuable. This helps researchers understand the real-world impact and whether it makes managing HIV easier for people.

Key takeaways

New long-acting treatment for HIV being tested.
Aims to help people whose current pills aren't fully controlling their virus.
Will assess how effective and safe the new treatment is.
Patient experiences are an important part of the study.
May offer an alternative to daily oral medication.

Who may be eligible?

To join this study, you generally need to be at least 12 years old and weigh at least 35 kilograms. You must have been diagnosed with HIV-1, and importantly, despite taking your current daily HIV medication, tests show that the amount of HIV in your blood is still detectable, but not extremely high. This means your current treatment isn't working as well as it could be, and doctors understand why (for example, if you've missed doses or had side effects with your current pills).

If you're able to become pregnant, you'll need to have a negative pregnancy test before starting. Everyone taking part, or their parent/guardian if they are under 18, must agree to join the study after understanding all the details.

There are also other medical checks that the study doctors will go through to make sure this trial is right for you and safe for you to take part.

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 at least 12 years old and weigh at least 35 kg?
Do you have HIV-1?
Is your current daily HIV medication not fully controlling the virus, meaning your virus levels are still detectable?
Are you willing and able to continue your current daily HIV medication for a period before potentially switching to the study treatment?
If you can become pregnant, are you willing to have a pregnancy test and use birth control?
Are you able to agree to take part after fully understanding the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue your current daily HIV medication for a period, typically until about a week after a specific visit around month six of the study. During this time, you will have regular visits to the clinic for health checks, blood tests to measure your HIV levels and general health, and to discuss how you're feeling.

Eventually, you would receive the study medication, which is a combination of two medicines given as injections. The study team will explain exactly when and how often these injections would be given. You'll continue to have medical appointments and tests throughout the study to monitor the treatment's effectiveness and safety. Patient feedback on your experiences with the treatment will also be collected at various points. The total duration of the study, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in this study could offer you the potential benefit of trying a new long-acting HIV treatment that might better control your HIV than your current medication. It could also mean fewer daily pills, which some people find easier. However, like all medicines, the study medication might have side effects, and some may be unexpected. The study doctors will carefully monitor your health throughout. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (89)

GSK Investigational Site
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Birmingham, United States· Recruiting
GSK Investigational Site
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Beverly Hills, United States· Withdrawn
GSK Investigational Site
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Los Angeles, United States· Recruiting
GSK Investigational Site
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Los Angeles, United States· Recruiting
GSK Investigational Site
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Los Angeles, United States· Recruiting
GSK Investigational Site
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Aurora, United States· Recruiting
GSK Investigational Site
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Denver, United States· Recruiting
GSK Investigational Site
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New Haven, United States· Recruiting
GSK Investigational Site
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Newark, United States· Recruiting
GSK Investigational Site
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Washington D.C., United States· Recruiting
GSK Investigational Site
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Jacksonville, United States· Recruiting
GSK Investigational Site
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Miami, United States· Recruiting

Common questions

What does 'long-acting' mean for this medicine?

It means you wouldn't take a pill every day. Instead, you'd receive injections less often, which could make managing your treatment easier.

Why is this study important for people with HIV?

It's important because it's looking for new, potentially more convenient and effective ways to control HIV, especially for those whose current daily pills aren't working as well as hoped.

What happens if the study medicine doesn't work for me?

The study team will closely monitor your health. If the medicine isn't working or if you have significant side effects, they will discuss other treatment options with you immediately.

Will I have to pay to be in this study?

No, you will not have to pay for the study medication or for appointments directly related to the study.

What if I get pregnant during the study?

If you are able to become pregnant, you'll need to use effective contraception throughout the study. If you do become pregnant, you should tell the study team immediately so they can discuss the best steps forward with you.

How to find out more

US GSK Clinical Trials Call Center

gskclinicalsupporthd@gsk.com 877-379-3718 Official trial record

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