Active not recruitingPHASE3INTERVENTIONAL

Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants

This study, called FLAIR, explores a new way to manage HIV-1. It's for adults whose HIV is already well-controlled with their current daily tablet treatment (specifically, a type called an integrase inhibitor single tablet regimen). The main goal is to see if switching to a new treatment plan – monthly injections of two medicines (cabotegravir and rilpivirine) – can keep the virus just as well under control. Participants will first take a standard HIV tablet for 20 weeks. If their HIV stays suppressed, they will then either continue their daily tablet or switch to a short period of new tablets, followed by monthly injections. This aims to find out if injections could be a convenient and effective long-term treatment option for HIV.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

ViiV Healthcare

Enrolment target

631

Start

27 Oct 2016

Estimated completion

31 Dec 2029

HIV Infections

What is this study about?

This study is called FLAIR, which stands for a new type of treatment for HIV-1. HIV is a virus that attacks the body's immune system. To keep healthy with HIV, people usually need to take antiretroviral medicines every day. This study is exploring a different way to take these medicines: through long-lasting injections given once a month.

The main aim of the FLAIR study is to find out if these monthly injections work as well as the daily tablets for people whose HIV is already under good control. They want to see if changing from a tablet you take every day to an injection once a month can keep the amount of virus in your body very low. This could potentially make managing HIV simpler and more convenient for some people, as they wouldn't have to remember to take a tablet every single day.

In this study, adults living with HIV who are new to treatment (meaning they haven't taken many HIV medicines before) will first start on a standard daily tablet. If their HIV levels become very low and stay low with this tablet, they will then be split into two groups. One group will continue with their daily tablet, and the other group will switch to a short course of new tablets, followed by the monthly injections. This comparison will help researchers understand if the monthly injections are just as effective and safe as the well-established daily tablet treatment.

Key takeaways

This study tests monthly HIV injections versus daily tablets.
It's for adults with HIV whose virus is already well-controlled.
Participation involves initial tablets, then either continued tablets or injections.
The study lasts at least 48 weeks, potentially longer.
The goal is a more convenient HIV treatment option.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with HIV-1. You must not have taken many HIV medicines before and your HIV levels in your blood must be relatively high when you first join the study (though they will be lowered with treatment during the study).

If you have previously taken certain types of HIV medicines (like an integrase inhibitor or a non-nucleoside reverse transcriptase inhibitor), you won't be able to join this study. If you're a woman, you can join if you're not pregnant or breastfeeding, and you must either be past childbearing age or agree to use highly effective birth control throughout the study and for a long time afterwards.

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 taken very few HIV medicines before?
Are you able to commit to regular hospital visits?
If you are a woman, are you not pregnant or breastfeeding, and willing to use effective birth control if needed?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll first take a daily HIV tablet for 20 weeks. During this time, the medical team will check your health and make sure your HIV is under control. If your HIV levels are very low after 20 weeks, you'll then be randomly assigned to one of two groups. One group will continue taking the same daily tablet. The other group will switch to a new set of daily tablets for about 4 weeks, and then receive monthly injections of the study medicines.

You'll have regular hospital visits for check-ups, blood tests, and to receive your medication (if you're in the injection group). The main part of the study will last for 48 weeks. If things go well, you might be offered the chance to continue in an 'extension phase', still receiving the monthly injections for a longer period. The total duration in the study could be several years, depending on various factors.

Potential risks and benefits

Taking part in this study could offer some benefits, such as receiving close medical care and potentially having a new, more convenient way to manage your HIV through monthly injections. However, like all medicines, there can be risks. The study medicines might have side effects, which the medical team will explain to you in detail. There's also the chance the new treatment might not work as well for you as your current medication. You are free to withdraw from the study at any time and for any reason, without it affecting your medical care.

Locations (44)

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

GSK Investigational Site
Verified postcode
Long Beach, United States
GSK Investigational Site
Verified postcode
Los Angeles, United States
GSK Investigational Site
Verified postcode
Los Angeles, United States
GSK Investigational Site
Verified postcode
Augusta, United States
GSK Investigational Site
Verified postcode
Macon, United States
GSK Investigational Site
Verified postcode
Austin, United States
GSK Investigational Site
Verified postcode
Bellaire, United States
GSK Investigational Site
Verified postcode
Dallas, United States
GSK Investigational Site
Verified postcode
Fort Worth, United States
GSK Investigational Site
Verified postcode
Aichi, Japan
GSK Investigational Site
Verified postcode
Osaka, Japan
GSK Investigational Site
Verified postcode
Tokyo, Japan

Common questions

What is HIV-1 RNA?

HIV-1 RNA is a measure of how much HIV virus is in your blood. Doctors aim for this number to be very low, meaning the virus is well under control.

What does 'integrase inhibitor' mean?

An integrase inhibitor is a type of medicine that stops the HIV virus from multiplying in your body. It's a common and effective part of HIV treatment.

What are 'antiretroviral-naive' participants?

This means people who have not taken many HIV medicines before, often meaning they are newly diagnosed or haven't had much previous treatment.

Will I have to pay for the medicines?

No, all study-related medicines and tests will be provided free of charge during the study.

What happens if the injections don't work for me?

Your health will be closely monitored. If the injections aren't keeping your HIV under control, the study team will discuss alternative treatment options with you, which may include going back to daily tablets.