Active not recruitingPHASE3INTERVENTIONAL

Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults

This study is for adults with HIV who are currently taking daily medication to keep their virus under control. It investigates whether switching to a new treatment, involving long-acting injections of two medicines (cabotegravir and rilpivirine) given once a month, is as safe and effective as continuing their usual daily pills. Some participants will start with a short course of daily pills before moving to injections. The study will compare these injected treatments to the current daily pill routines to make sure the new approach works just as well to keep HIV levels low. After a year, those who continued their daily pills may also get the option to switch to the injections.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

ViiV Healthcare

Enrolment target

618

Start

28 Oct 2016

Estimated completion

31 Dec 2029

Infection, Human Immunodeficiency Virus HIV Infections

Results

Results from this study

Posted June 2019

Results have been published for this study.

Primary outcome

Number of Participants With Virologic Failure (HIV-1 Ribonucleic Acid [RNA] >=50 Copies Per Millilter [mL]) Using Snapshot Algorithm at Week 48

Number of participants with virologic failure endpoint (HIV-1 RNA\>=50 c/mL) as per Food and Drug Administration (FDA) snapshot algorithm at Week 48 was assessed to demonstrate the non-inferior antiviral activity of switching to intramuscular (IM) CAB LA+RPV LA every 4 weeks compared to continuation of current ART regimen over 48 weeks in HIV-1 infected ART-experienced participants. The HIV-1 RNA \>=50 copies/mL per snapshot algorithm was determined by the last available on-treatment HIV-1 RNA measurement within the analysis visit window of interest.

Full results on the registry

What is this study about?

This study, called ATLAS, is looking for a new way to treat HIV in adults. Right now, most people with HIV take daily pills to keep the virus levels very low, which is called being 'virally suppressed'. This study wants to see if switching from these daily pills to a new treatment that involves long-acting injections, given only once a month, works just as well. The injections use two medicines called cabotegravir and rilpivirine.

The main goal is to find out if these monthly injections can keep HIV levels suppressed just as effectively as the daily pills. This is called 'non-inferiority', meaning it's not worse than the current treatment. To do this, the study will compare people who switch to the injections with people who continue their usual daily pills. Both groups will be carefully monitored.

At the start, some participants will switch to the new treatment straight away, which involves taking oral pills of cabotegravir and rilpivirine for four weeks, then starting the monthly injections. Other participants will continue their current daily HIV medication for a year. After this year, those who stayed on their daily pills will then have the option to switch to the monthly injections, following the same four-week oral lead-in. This will help doctors understand if a long-acting injectable treatment could be a good and convenient option for people living with HIV, potentially reducing the need for daily pills.

Key takeaways

This study explores a new long-acting injectable HIV treatment given monthly.
It's for adults whose HIV is already well-controlled with daily pills.
The aim is to see if injections work as well as current daily medication.
Participation involves either switching to injections or continuing current pills, with possible switch later.
Regular clinic visits and monitoring will be part of the study.

Who may be eligible?

To join this study, you need to be an adult, 18 years or older, who is currently living with HIV. It’s important that your HIV has been well-controlled for at least 6 months using your current daily medication, meaning the virus levels in your blood are very low and stable. This also means you haven't recently changed your HIV medication because it wasn't working to control the virus.

Your current HIV treatment needs to include two specific types of medication (NRTIs) plus a third medicine, which could be an INI, NNRTI, or PI. The doctors running the study will check your medical history to make sure your past treatments and any changes were for reasons like side effects or convenience, not because your HIV wasn't being controlled.

For women, you must not be pregnant to take part in this study. The study team will carry out tests to confirm this. These criteria help ensure the study is safe and that results are clear for those who might benefit most from this new treatment approach.

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?
Is your HIV currently well-controlled (virally suppressed) with medication for at least 6 months?
Are you currently taking two NRTIs plus another HIV medicine (INI, NNRTI, or PI)?
Have you not changed your HIV medication recently because it wasn't working?
If you are a woman, are you not pregnant?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly put into one of two groups. One group will continue their current daily HIV pills for about a year. The other group will switch to the new treatment: you'll start with daily oral pills of cabotegravir and rilpivirine for four weeks, then receive monthly injections of these medicines for the rest of the study. After about a year, those who continued their daily pills will be given the option to also switch to the monthly injections, starting with the four weeks of oral pills.

Throughout the study, you'll have regular visits to the clinic for blood tests, physical exams, and to discuss how you're feeling and if you have any side effects. This will help the study team monitor your health and how well the treatment is working. The study is ongoing, so the total duration of your participation could vary, but you'll be told about the expected length during your initial discussions with the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit could be access to a new, long-acting HIV treatment that might make managing your condition more convenient by replacing daily pills with monthly injections. However, there's no guarantee the new treatment will work for you or be better than your current medication. Potential risks include side effects from the new medicines or injections, such as pain or reactions at the injection site, or other unforeseen side effects. Your current HIV medication might also have side effects. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (113)

GSK Investigational Site
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Birmingham, United States
GSK Investigational Site
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Phoenix, United States
GSK Investigational Site
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Bakersfield, United States
GSK Investigational Site
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Long Beach, United States
GSK Investigational Site
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Los Angeles, United States
GSK Investigational Site
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Los Angeles, United States
GSK Investigational Site
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Palm Springs, United States
GSK Investigational Site
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San Francisco, United States
GSK Investigational Site
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San Francisco, United States
GSK Investigational Site
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Denver, United States
GSK Investigational Site
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Washington D.C., United States
GSK Investigational Site
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Washington D.C., United States

Common questions

What is 'long-acting' treatment?

Long-acting treatment means medicine is given less often, like once a month by injection, instead of taking pills every day.

What does 'virally suppressed' mean?

It means your HIV is well under control and the amount of virus in your blood is very low, usually so low it can't be detected by standard tests.

Will I have to stop my current HIV medication?

If you're in the group that switches, you'll stop your current pills and start the study medication. If you're in the comparison group, you'll continue your current medication for a year before possibly switching.

Are the injections painful?

Some people might feel pain or discomfort at the injection site, similar to other injections you might have had.

What if the new treatment doesn't work for me?

The study team will monitor you closely. If the new treatment isn't working as it should, or if you experience significant side effects, you will be able to discuss options with your doctor.