RecruitingPHASE3INTERVENTIONAL

A Study to Investigate Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA) in Adults and Adolescents With HIV Who Are Virologically Suppressed

This study is looking into a new way to treat HIV for people whose virus is already well-controlled. Currently, many people take daily pills. This research is testing a new injectable treatment that might be given less often – potentially every few months. It combines two medications, cabotegravir ultra long-acting (CAB ULA) and rilpivirine ultra long-acting (RPV ULA). Researchers want to see if this new, even longer-lasting injection works as well as, and is as safe as, the existing long-acting injectable treatments for HIV (CAB LA and RPV LA), which are given every one to two months. The goal is to make HIV treatment even more convenient and effective for adults and teenagers.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

ViiV Healthcare

Enrolment target

564

Start

25 Jun 2026

Estimated completion

04 Sep 2029

HIV Infections

What is this study about?

This research study is about finding better and more convenient ways to treat HIV. For many years, people with HIV have taken daily pills to keep the virus under control. More recently, long-acting injectable treatments have become available, meaning people can get injections every one or two months instead of taking daily pills.

This particular study is looking at an even newer type of long-acting injection. It uses medications called cabotegravir (CAB) and rilpivirine (RPV), but in a super long-acting form (ULA). The idea is that these ULA injections might be needed even less often than the current long-acting injections. The study wants to compare this new ultra long-acting combination to the current long-acting injections (CAB LA and RPV LA) to see if it works just as well, is safe, and easy for people to tolerate.

The reason this matters is that treatments that are given less often can make a big difference to people's lives. It can mean fewer clinic visits, less worry about remembering daily pills, and more freedom. This study aims to see if this super long-acting option can be a good choice for adults and teenagers who are already managing their HIV very well.

Key takeaways

Tests a new, super long-acting injectable HIV treatment.
Aims to make HIV treatment more convenient, potentially fewer injections.
For adults and teenagers whose HIV is already well-controlled.
Compares new injections to existing long-acting HIV injections.
Focuses on safety, effectiveness, and how well people tolerate the treatment.

Who may be eligible?

To join this study, you would need to be an adult or a teenager aged 12 or older, weighing more than 35 kilograms (about 5 and a half stone). It's important that your HIV has been well-controlled for a long time, meaning the amount of virus in your blood has been very low (undetectable) for at least the last 12 months, and still is when you join the study. You also need to have been taking your current daily HIV medication regularly for at least six months without any breaks. If you've changed your HIV medication in the past, it must have been for reasons like side effects, convenience, or access, and not because your previous treatment stopped working effectively.

There are also reasons why you might not be able to join. For example, if tests show that the HIV virus in your body has certain changes that might make the study drugs less effective (this is called 'resistance'). You also can't have had any special HIV 'vaccine' treatments in the last three months, or have ever received any long-acting HIV treatments before, including the specific medications (cabotegravir or rilpivirine) being tested. Finally, if you have other serious health problems that aren't well-controlled (like heart, liver, kidney, or mental health issues), you might not be able 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 12 years old or older and weigh more than 35 kg?
Has your HIV been undetectable (very well-controlled) for the last 12 months?
Are you currently taking daily HIV pills and have been for at least 6 months?
Have you never had long-acting HIV injections before?
Do you have any serious, uncontrolled health conditions (like heart, liver, or kidney problems)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medications as injections. You would have regular visits to the clinic for check-ups, blood tests, and to get your injections. The research team would monitor your health closely, including checking how well the treatment is working and looking for any side effects. The exact number of visits and the total length of time you'd be in the study would be explained in detail by the study team, but typically, clinical trials involve a period of active treatment followed by a follow-up period to ensure your safety and monitor long-term effects.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as access to a new, potentially more convenient treatment option before it's widely available. You'd also receive very close medical monitoring and care. However, like all medicines, the study treatments could have side effects, and some might be unknown. There's also no guarantee the new treatment will work as well for you as your current medication. The study team will explain all known risks. Remember, participation is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (88)

GSK Investigational Site
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Phoenix, United States· Recruiting
GSK Investigational Site
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Bakersfield, 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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San Diego, United States· Recruiting
GSK Investigational Site
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New Haven, United States· Recruiting
GSK Investigational Site
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Washington D.C., United States· Recruiting
GSK Investigational Site
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DeLand, United States· Recruiting
GSK Investigational Site
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Fort Lauderdale, United States· Recruiting
GSK Investigational Site
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Ft. Pierce, United States· Recruiting
GSK Investigational Site
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Miami, United States· Recruiting
GSK Investigational Site
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Orlando, United States· Recruiting

Common questions

What kind of treatment is being tested?

It's a new combination of two very long-acting injectable medicines for HIV, called cabotegravir and rilpivirine. They are given as injections, not daily pills.

Who is this study for?

It's for adults and teenagers (12 years or older) who have HIV that is already very well-controlled with their current daily medication.

What is 'virologically suppressed'?

This means the amount of HIV in your blood is so low it can't be detected by standard tests, showing your treatment is working very well.

What if I've changed my HIV medication recently?

You need to have been on your current daily HIV medication for at least six months without interruption, and any previous changes couldn't have been because your old treatment stopped working.

Will I have to stop my current HIV medicine?

If you join the study, you would switch from your daily pills to the study injections. This would be carefully managed by the study doctors.

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.