A study of islatravir and ulonivirine for adults with HIV who have not received previous treatment

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What is this study about?

This study is being conducted to investigate a new treatment approach for people living with HIV. The research focuses on testing the effectiveness and safety of two experimental drugs, islatravir and ulonivirine, which are combined in a single medication known as MK-8591B. This combination is intended to be taken once a week. The study will compare this weekly regimen against a standard daily medication containing bictegravir, emtricitabine, and tenofovir alafenamide.

The goal of the study is to evaluate how well the experimental treatment controls the HIV-1 RNA, which is a measure of the amount of virus in the blood. The research also aims to monitor the safety and how well the body tolerates the medications over time. During the course of the study, participants will be observed for a set period to track changes in their viral levels and their CD4+ T-cell count, which is a type of white blood cell that helps the body fight infections.

The study is divided into two stages. In the first stage, the effectiveness and safety of the weekly treatment are assessed in an open manner. In the second stage, a more controlled method is used where neither the participants nor the researchers know which specific treatment is being administered to ensure unbiased results. Participants will be monitored through various stages of the study to collect data on how the virus responds to the treatment and to identify any potential side effects.

Who Can Join the Study?

  • You must be positive for HIV-1, which is a specific type of the human immunodeficiency virus.
  • For the second stage of the study, the amount of HIV-1 RNA (the genetic material of the virus) in your blood must be between 500 and 100,000 copies per milliliter.
  • For the third stage of the study, the amount of HIV-1 RNA in your blood must be 500 copies per milliliter or more.
  • For the second stage of the study, you must have a CD4+ T-cell count of at least 200 cells per cubic millimeter. CD4+ T-cells are a type of white blood cell that helps your body fight infections.
  • You must be naïve to antiretroviral therapy, which means you have never taken any antiretroviral medication (drugs used to treat HIV) after being diagnosed with the virus.
  • You must be between the ages of 3 and 12 years old.

Who Cannot Join the Study?

  • You have an infection caused by human immunodeficiency virus type 2 (HIV-2), which is a different type of virus than the more common HIV-1.
  • You have been diagnosed with an opportunistic infection, which is a serious infection that occurs more frequently or more severely in people with weakened immune systems, specifically those with AIDS (acquired immune deficiency syndrome).
  • You have an active infection of the hepatitis C virus (HCV) or the hepatitis B virus (HBV), which are viruses that cause inflammation of the liver.
  • You have had malignancy, which is another word for cancer, within the last 5 years, unless it was a specific type of skin cancer or early-stage cancer that has been properly treated.
  • You have previously taken islatravir (ISL) or ulonivirine (ULO) at any time before starting this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier De Tourcoing Tourcoing France
Centre Hospitalier Universitaire De Nimes Nimes France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Pellegrin Hospital Bordeaux France
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Hospital General Universitario De Valencia Valencia Spain
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Hopital Beaujon Clichy France
Hospital Universitario Virgen De La Victoria Malaga Spain
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Hkledrak Uoyxwkcyalxyj Hhgnoxbl Thwoj y Pwakek Inxdxfee Cznpvl dffstbhmcspktcmzn (nzcb Badalona Spain
Cuy Cmizn Razqtokppmh Lyon France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
15.02.2026
Spain Spain
Recruiting
15.02.2026

Trial locations

Islatravir is an experimental medication being tested for its ability to help manage HIV by preventing the virus from replicating in the body.

Ulonivirine is an experimental medication being tested to see how well it works as a treatment to control HIV levels.

MK-8591B is a combination of two experimental medicines, islatravir and ulonivirine, being studied together to evaluate their effectiveness in treating HIV.

Bictegravir, emtricitabine, and tenofovir alafenamide is a standard daily medication used as a comparison to see how the new experimental treatments perform in controlling the HIV virus.

Human Immunodeficiency Virus Type 1 – This is a virus that attacks the body’s immune system, specifically the cells that help the body fight off infections. As the virus replicates, it gradually reduces the number of these important immune cells. Over time, the decreasing cell count makes the body more susceptible to various illnesses. The virus remains in the body and continues to multiply throughout the course of the infection.

Trial ID:
2025-522519-40-00
Protocol code:
MK-8591B-062
Trial Phase:
Therapeutic use (Phase IV)

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