Active not recruitingPHASE3INTERVENTIONAL

A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)

This research study is investigating a new combination of two medicines, Doravirine and Islatravir (DOR/ISL), for people with HIV-1. Currently, participants in this study are managing their HIV very well on a different, established treatment called Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF). The main goal of this study is to find out if switching from BIC/FTC/TAF to the new DOR/ISL combination is just as good at keeping the HIV virus under control after 48 weeks. Researchers will also be carefully checking for any side effects or safety concerns with the new treatment. This is important to see if DOR/ISL could be another effective and safe option for people living with HIV.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

514

Start

17 Feb 2023

Estimated completion

04 Aug 2028

HIV-1 Infection

What is this study about?

This study is for people living with HIV-1 infection. HIV-1 is a virus that attacks the body's immune system. Luckily, there are many effective medicines available today that can help people with HIV lead long and healthy lives by keeping the virus under control.

Currently, many people with HIV are treated with a combination medicine called Bictegravir/Emtricitabine/Tenofovir Alafenamide (which we’ll call BIC/FTC/TAF for short). This medicine is very good at reducing the amount of HIV in the body to very low, undetectable levels, meaning the virus is well-controlled. This study is looking at a new combination of two drugs, Doravirine and Islatravir (which we'll call DOR/ISL), as a potential alternative.

The main aim is to see if switching to DOR/ISL is just as effective as continuing with BIC/FTC/TAF in keeping the HIV virus under control. Researchers also want to make sure that DOR/ISL is safe and well-tolerated. Finding new and equally effective treatment options is always important because it gives people more choices and can help tailor treatment to individual needs.

Key takeaways

This study evaluates a new two-drug HIV treatment called DOR/ISL.
It's for people with HIV-1 who are currently well-controlled on BIC/FTC/TAF.
The main goal is to see if DOR/ISL is as effective and safe as current treatment.
The study lasts for 48 weeks with regular clinic visits.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you must be 18 years or older and have HIV-1. A key requirement is that you must have been taking a specific HIV medicine called BIC/FTC/TAF for at least three months, and it must be successfully keeping your HIV under control (meaning the virus levels in your blood are very low and stable). You also shouldn't have a history of your HIV treatment failing in the past.

There are also some reasons why you might not be able to join. For example, if you have other serious health conditions like active hepatitis B, certain types of hepatitis C, or specific cancers, you might not be eligible. If you've recently had certain severe infections or are taking medications that could interfere with the study drugs, that would also prevent you from joining. Women who are pregnant, breastfeeding, or could become pregnant during the study would need to use effective contraception or avoid sex.

Finally, you cannot have HIV-2, and if you've ever taken certain long-acting HIV treatments or participated in another study involving a new experimental treatment recently, you might not be able to take part. The research team will carefully check all these details with you.

Quick self-check

Are you 18 years or older?
Do you have HIV-1?
Have you been taking BIC/FTC/TAF for at least 3 months with very low HIV levels?
Are you female and not pregnant, breastfeeding, or willing to use effective contraception if you could become pregnant?
Do you have any other serious health conditions like active hepatitis B or specific cancers?
Are you taking any other long-acting HIV treatments or certain strong medications?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will either switch from your current medication (BIC/FTC/TAF) to the new study medication (DOR/ISL), or you will continue taking your BIC/FTC/TAF. You won't know which one you're on, and neither will your study doctor, as this is a 'blinded' study. The study goes on for 48 weeks, which is about 11 months.

During this time, you will have regular visits to the clinic so the study team can check on your health, how well the treatment is working, and if you're experiencing any side effects. These visits will involve blood tests to measure your HIV levels and other health markers, physical examinations, and questions about how you are feeling. The study team will provide all the necessary medication, and some visits might include discussions about your general wellbeing. A full commitment for the 48-week period is essential, with continued follow-up if needed.

Potential risks and benefits

Participating in any clinical study has potential benefits and risks. You might benefit from closer medical attention and access to a potentially new and effective treatment option (DOR/ISL) that could offer advantages, such as a different side effect profile. However, there's always a possibility that the new treatment might not be as effective as your current one or could cause unexpected side effects. Researchers will be carefully monitoring your health throughout the study. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (49)

Pueblo Family Physicians ( Site 1425)
Phoenix, United States
Pacific Oaks Medical Group ( Site 1400)
Beverly Hills, United States
Ruane Clinical Research Group, Inc ( Site 1414)
Los Angeles, United States
Mills Clinical Research ( Site 1433)
Los Angeles, United States
Whitman-Walker Institute ( Site 1431)
Washington D.C., United States
Therafirst Medical Center ( Site 1402)
Fort Lauderdale, United States
Midway Immunology and Research Center ( Site 1401)
Ft. Pierce, United States
AHF The Kinder Medical Group ( Site 1426)
Miami, United States
Orlando Immunology Center ( Site 1407)
Orlando, United States
Triple O Research Institute, P.A ( Site 1417)
West Palm Beach, United States
Infectious Disease Specialists of Atlanta ( Site 1403)
Decatur, United States
Mercer University, Department of Internal Medicine ( Site 1411)
Macon, United States

+37 more sites — see the official record for the full list.

Common questions

What is HIV-1?

HIV-1 is a type of virus that affects the body's immune system, making it harder to fight off infections and diseases. Medicines help keep the virus under control.

What does 'virologically suppressed' mean?

It means the amount of HIV in your blood is very low, usually undetectable with standard tests, because your current medication is working very well.

Why is this study 'blinded'?

A 'blinded' study means neither you nor your study doctor knows if you're getting the new treatment or continuing your current one. This helps ensure the results are fair and unbiased.

How long will I be in the study?

The main part of the study lasts for 48 weeks, which is just under a year. There might be some follow-up after that.

Will I have to pay for the study medication or visits?

No, all study-related medication, tests, and visits will be provided at no cost to you.