A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Budigalimab and/or ABBV-382 in People Living with HIV on Stable Antiretroviral Therapy Undergoing Analytical Treatment Interruption.
This study is for people living with HIV who are currently taking their regular HIV medication and have their virus well-controlled. We are testing two new medicines, Budigalimab and ABBV-382, to see if they can help people keep HIV under control even after they stop their usual daily treatment for a time. Participants will be split into groups; some will receive one of the new medicines, some will receive both, and others will receive a placebo (a dummy drug). Doctors will carefully watch participants' health and HIV levels during this period. The main goal is to see if, after stopping regular HIV medication, the virus stays at very low levels (under 1000 copies/mL) for at least 24 weeks without needing to restart their usual treatment.
At a glance
What is this study about?
This study is testing new ways to manage HIV. Currently, people living with HIV take daily medication (ART) to keep the virus under control. While very effective, these treatments are lifelong. Researchers are looking for treatments that might allow people to take a break from daily ART, or even control the virus without it.
In this study, we are looking at two new potential medicines, Budigalimab and ABBV-382. These medicines work differently from current HIV treatments. We want to see if giving these new medicines can help a person's body control the HIV virus for a time, even after they stop taking their usual daily ART.
This is a 'Phase 2' study, which means we are trying to find out if these new medicines are effective and safe. We will compare them to a 'placebo', which looks like the real medicine but contains no active drug. This helps us understand if any changes we see are truly due to the new medicines.
Key takeaways
- This study explores new HIV treatments that might allow a break from daily medication.
- It tests two new medicines, Budigalimab and ABBV-382.
- Participants will temporarily stop their usual HIV medicine under strict medical watch.
- The main goal is to see if HIV stays low for 24 weeks without usual treatment.
- Your health and safety are closely monitored; you would restart daily ART if needed.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. Both men and women can take part.
You must be currently living with HIV and taking regular HIV medication (ART) that is successfully keeping your virus levels very low and stable. This means your HIV is well-controlled by your current medicines.
Your study doctor will check other health details to make sure this study is safe and right for you. They will explain everything clearly before you decide 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 18 years old or older?
- Do you have HIV?
- Are you currently taking regular HIV medication and is your virus well-controlled?
- Are you willing to temporarily stop your regular HIV medication under medical supervision as part of the study?
What does participation involve?
If you decide to join, you will be randomly assigned to one of several groups. Some groups will receive Budigalimab, some ABBV-382, some both, and others a placebo. You will not know which group you are in, and neither will your main doctor.
Initially, you will take the study medicine for a period. After this, under close medical supervision, you will temporarily stop your usual daily HIV medicine (this is called an 'analytical treatment interruption'). Doctors will very carefully monitor your HIV levels and general health throughout this entire period. If your HIV levels go up too much at any point, or if you become unwell, you will restart your regular HIV medication straight away. You will have regular visits to the clinic for blood tests and check-ups. The total duration of your participation, including follow-up, could last for several months to a year or more. The study team will explain the exact schedule of visits and treatments.
Potential risks and benefits
Locations (7)
- —UnverifiedGermany
- —UnverifiedDenmark
- —UnverifiedItaly
- —UnverifiedFrance
- —UnverifiedPoland
- —UnverifiedBelgium
- —UnverifiedSpain
Common questions
What is 'analytical treatment interruption'?
This is a carefully planned and monitored temporary pause from your usual HIV medication, done under strict medical supervision in a study setting.
What is a 'placebo'?
A placebo is a dummy drug that looks like the real medicine but has no active ingredients. It helps researchers see if the real medicine is truly making a difference.
Will I have to stop my current HIV medication forever if I join?
No, you will only stop your current HIV medication temporarily and under close supervision. If your HIV levels rise, you will restart your usual treatment immediately.
What happens if the new medicine doesn't work for me?
Your doctors will be monitoring you very closely. If the new medicine isn't working, or if your HIV levels start to go up, you will be taken off the study and will restart your standard HIV medication.
How long will I be in the study?
The study involves a period of taking the new medicine, followed by a period where your HIV levels are monitored after pausing your usual medication. The total time in the study could be several months to over a year, including follow-up visits.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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