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Study on Switching to Doravirine and Islatravir for People with HIV-1 on Antiretroviral Therapy

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What is this study about?

This clinical trial is focused on studying the treatment of HIV-1 infection, a virus that attacks the immune system. The study involves participants who are currently taking antiretroviral therapy, which is a type of medication used to manage HIV. The trial will explore the effects of switching to a new combination of medications called doravirine and islatravir, which are taken together in a single tablet. Doravirine is a medication that helps prevent the virus from multiplying, while islatravir is a new type of medication being studied for its potential to enhance the treatment of HIV.

The purpose of the study is to evaluate how effective and safe this new combination is compared to the participants’ current antiretroviral therapy. Participants will be randomly assigned to either continue their current treatment or switch to the new combination of doravirine and islatravir. The study will last for about 96 weeks, during which participants will take their assigned medication daily. Regular check-ups will be conducted to monitor the health and progress of the participants, focusing on the amount of virus in their blood and any side effects they may experience.

Throughout the study, the researchers will pay close attention to the participants’ health, ensuring that the new treatment is both effective in controlling the virus and safe for long-term use. The trial aims to provide valuable information on whether switching to this new combination can offer a better treatment option for people living with HIV-1. Participants will be closely monitored to ensure their well-being and to gather data on the effectiveness of the new treatment approach.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose and procedures. You will be asked to provide your consent to participate.

You must meet certain criteria, such as having HIV-1 with a viral load of less than 50 copies/mL and being on a stable antiretroviral therapy for at least three months.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes a review of your medical history and a physical examination.

A blood test will be performed to measure your HIV-1 viral load and other health indicators.

3 treatment switch

If eligible, you will switch from your current antiretroviral therapy to a new combination of doravirine and islatravir (100 mg/0.25 mg) taken once daily as a film-coated tablet.

You will continue this new treatment for the duration of the study, which is up to 96 weeks.

4 regular follow-up visits

You will attend regular follow-up visits to monitor your health and the effectiveness of the new treatment. These visits will occur at specified intervals, such as every few weeks.

During these visits, blood tests will be conducted to check your HIV-1 viral load and other health markers.

5 safety and tolerability assessment

Throughout the study, your safety and how well you tolerate the new treatment will be closely monitored.

You will be asked to report any side effects or adverse events you experience during the study.

6 final evaluation

At the end of the study period, a final evaluation will be conducted to assess the overall effectiveness and safety of the treatment switch.

This will include a comprehensive review of your health status and any changes in your HIV-1 viral load.

Who Can Join the Study?

  • The patient must be HIV-1 positive and have less than 50 copies of HIV-1 RNA (a type of genetic material from the virus) per milliliter in their blood at the time of screening.
  • The patient must have been taking a stable combination of 2 or 3 HIV medications (with or without a booster to help the drugs work better) for at least 3 months before joining the study. During this time, their HIV-1 RNA levels must have been consistently below 50 copies per milliliter, and they must not have had any previous treatment failures with these medications.
  • If the patient is a female who can become pregnant, she must use an acceptable method of birth control or choose not to have vaginal intercourse. She must also have a negative pregnancy test and discuss her medical history, menstrual cycle, and recent sexual activity with the study doctor.

Who Cannot Join the Study?

  • Patients with a current or past infection of HIV-1 cannot participate. HIV-1 is a type of virus that affects the immune system.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of participants.
  • Patients who are not male or female cannot participate. The study is open to both men and women.
  • Patients who are considered part of a vulnerable population cannot participate. This refers to groups of people who might be at higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy

Other Sites

Site Name City Country Status
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Centre Hospitalier Universitaire De Nice Nice France
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire De Nantes Nantes France
National Institute For Infectious Diseases Lazzaro Spallanzani Rome Italy
Centre Hospitalier Universitaire De Nimes Nimes France
ASST Fatebenefratelli Sacco Milan Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Infanta Leonor Madrid Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Hopital Purpan Toulouse France
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Hblzihkd Uzapwfpldlysz Hwfvxsgb Thewt y Pxpcam Iatbfqjj Cugeyb dyvxomuokxhpyjofp (gods Badalona Spain
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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
Not yet recruiting
03.05.2023
Italy Italy
Not yet recruiting
03.05.2023
Spain Spain
Not yet recruiting
03.05.2023

Trial locations

Investigated drugs:

Doravirine is a medication used to treat HIV-1, which is the most common type of HIV. It works by blocking a specific protein that the virus needs to multiply, helping to control the infection and reduce the amount of virus in the body. This can help improve the immune system and decrease the chance of developing HIV-related illnesses.

Islatravir is another medication used in the treatment of HIV-1. It helps to prevent the virus from multiplying by interfering with its ability to replicate. By doing so, it helps to lower the viral load in the body, which can lead to better control of the infection and support the immune system in fighting off other infections.

Investigated diseases:

HIV-1 Infection – Human Immunodeficiency Virus type 1 (HIV-1) infection is a viral condition that targets the immune system, specifically the CD4+ T cells, which are crucial for immune response. As the virus replicates, it gradually depletes these cells, weakening the body’s ability to fight off infections and diseases. The progression of HIV-1 infection can lead to a significant reduction in CD4+ T cell count, making the individual more susceptible to opportunistic infections. Over time, if untreated, the infection can advance to Acquired Immunodeficiency Syndrome (AIDS), characterized by a severely compromised immune system. The virus is primarily transmitted through contact with infected bodily fluids, such as blood, semen, vaginal fluids, and breast milk. The progression of the disease can vary greatly among individuals, influenced by factors such as viral load, genetic factors, and overall health.

Trial ID:
2022-502127-22-00
Protocol code:
MK-8591A-051
Trial Phase:
Therapeutic confirmatory (Phase III)

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