Active not recruitingPHASE3INTERVENTIONAL

DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)

This research study, called MK-8591A-053, is looking at a new combination medicine, DOR/ISL, for adults who have recently been diagnosed with HIV-1 and have not yet started any HIV treatment. The study aims to see how well this new medicine works, if it's safe, and how people tolerate it, compared to a commonly used existing HIV treatment called BIC/FTC/TAF. Researchers want to find out if DOR/ISL can lower the amount of HIV in the blood to very low levels, similar to the existing treatment, after 48 weeks. This is a Phase 3 study, meaning it's one of the final steps before a new medicine might be approved for wider use.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

537

Start

08 Mar 2023

Estimated completion

05 Aug 2029

HIV-1 Infection

What is this study about?

This study is a clinical trial exploring a new medication combination for people living with HIV-1. The new medicine is called DOR/ISL. It's designed for individuals who have recently found out they have HIV-1 and haven't started any treatment for it yet. The main goal is to see if DOR/ISL can effectively reduce the level of HIV in the blood, known as the 'viral load', to a very low, undetectable level. This is important because reducing the viral load helps people with HIV stay healthy and also greatly reduces the risk of passing the virus to others.

The study will compare DOR/ISL to an existing, approved HIV treatment called BIC/FTC/TAF. By comparing it to an established medicine, researchers can determine if DOR/ISL is at least as good at controlling HIV, while also monitoring for any side effects and how well people tolerate it. This type of study is called 'double-blind,' which means neither you nor your study doctor will know whether you are receiving DOR/ISL or the existing treatment. This helps ensure the results are as fair and unbiased as possible.

This is a 'Phase 3' study, which means the new medication has already been tested in smaller groups of people and shown some promising results. Phase 3 trials involve larger groups and are usually the last step before a new medicine can be considered for approval by health authorities to be used more widely. Participating in this study could help advance our understanding of HIV treatment options.

Key takeaways

This study is testing a new HIV medicine (DOR/ISL) against an existing treatment.
It's for adults newly diagnosed with HIV-1 who haven't started treatment yet.
The main goal is to see if the new medicine works as well as the existing one in reducing HIV levels.
Your health will be closely monitored throughout the study.
You will either receive the new medicine or an existing, proven HIV treatment.
Participation is voluntary, and you can leave at any time.

Who may be eligible?

To join this study, you must be an adult aged 18 or older with HIV-1. Your HIV-1 must be active, meaning there's a certain amount of the virus in your blood. You also must not have taken any HIV medication before.

There are several reasons why someone might not be able to join. For example, if you are also infected with HIV-2, or if you have severe allergies to any of the medicines in the study. You also can't have active hepatitis B, or chronic hepatitis C with signs of severe liver damage. If you've had certain cancers recently, or have any other health conditions that your study doctor thinks might make it unsafe for you to participate or might affect the study's results, you might not be able to join. If you are pregnant or breastfeeding, or planning to become pregnant during the study, you also cannot participate, unless you commit to using reliable contraception.

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-1 and have never taken HIV medication before?
Is your HIV active (a certain level of virus in your blood)?
Are you not pregnant or breastfeeding, and willing to use contraception if needed?
Do you *not* have active hepatitis B or certain liver problems due to hepatitis C?
Have you *not* had certain cancers or other serious health issues recently?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the new medicine combination (DOR/ISL) or an existing HIV medicine (BIC/FTC/TAF). You won't know which one you're receiving, and neither will your study doctor. You will need to take the study medicine regularly as instructed. You can expect to have regular visits to the clinic for check-ups, blood tests, and to make sure you're feeling well and the treatment is working. The study will last for a specific period, and during that time, your health and the levels of HIV in your blood will be carefully monitored. The study will assess the main outcome after 48 weeks, but follow-up will continue after this point. More specific details about the frequency of visits and tests will be explained by the study team.

Potential risks and benefits

By taking part, you could potentially benefit from receiving a new HIV treatment or a proven existing one, and your health will be closely monitored by medical professionals. However, there are potential risks, as with any medication, including possible side effects from the study drugs. These will be fully explained to you before you consent to participate. You will always have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (131)

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

Pueblo Family Physicians ( Site 5674)
Verified postcode
Phoenix, United States
Pacific Oaks Medical Group ( Site 5681)
Verified postcode
Beverly Hills, United States
Ruane Clinical Research Group, Inc ( Site 5658)
Verified postcode
Los Angeles, United States
Vivent Health ( Site 5694)
Verified postcode
Denver, United States
Washington Health Institute ( Site 5689)
Verified postcode
Washington D.C., United States
Midway Immunology and Research Center ( Site 5657)
Verified postcode
Ft. Pierce, United States
AHF The Kinder Medical Group ( Site 5672)
Verified postcode
Miami, United States
AHF South Beach ( Site 5663)
Verified postcode
Miami Beach, United States
Orlando Immunology Center ( Site 5654)
Verified postcode
Orlando, United States
CAN Community Health - Sarasota ( Site 5668)
Verified postcode
Sarasota, United States
Triple O Research Institute, P.A ( Site 5666)
Verified postcode
West Palm Beach, United States
Emory University and Grady Health System-Medicine ( Site 5690)
Verified postcode
Atlanta, United States

Common questions

What is HIV-1?

HIV-1 is a type of human immunodeficiency virus, which can weaken your immune system if not treated.

What does 'treatment-naïve' mean?

It means you have recently been diagnosed with HIV-1 and have never taken any medication for HIV before.

What is a 'Phase 3' study?

Phase 3 is usually the last step in testing a new medicine in a larger group of people before it might be approved for wider use.

Will I know which medicine I'm getting?

No, neither you nor your doctor will know which medicine you're receiving. This is called 'double-blind' and helps make the study fair.

How long will the study last?

The study will track results for at least 48 weeks (almost a year), but your participation might continue for longer check-ups. The study team will give you exact details.