Study on the Safety of Doravirine and Islatravir for HIV Patients Who Previously Participated in Doravirine/Islatravir Trials

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What is this study about?

This clinical trial is focused on studying the treatment of HIV infection using a medication called Doravirine/Islatravir (also known by the code name MK-8591A). The medication is taken as a film-coated tablet and is designed to be taken once daily. The purpose of the study is to evaluate the safety and tolerability of this treatment in participants who have previously received it in earlier clinical studies.

Participants in this study will continue to take the Doravirine/Islatravir tablet as part of their treatment for HIV infection. The study will monitor participants over a period to gather information on any serious adverse events or reasons for discontinuing the treatment due to adverse effects. This information will help researchers understand how well the treatment is tolerated by those who have already been using it.

The study is open-label, meaning that both the participants and the researchers know which treatment is being administered. This trial is a continuation for those who have already been part of previous studies involving Doravirine/Islatravir, allowing them to continue their treatment while contributing to the collection of important safety data.

1 joining the study

Participation begins after completing a previous clinical study involving the combination of doravirine and islatravir.

Eligibility requires having received clinical benefit from the previous study and weighing at least 35 kg.

Female participants must not be pregnant or breastfeeding and must agree to use contraception if of childbearing potential.

2 medication administration

The medication, known as MK-8591A, is taken orally as a film-coated tablet.

The dosage consists of 100 mg of doravirine and 0.75 mg of islatravir, administered once daily.

3 monitoring and evaluation

The main objective is to assess the safety and tolerability of the medication through accumulated safety data.

Monitoring includes tracking any serious adverse events and any discontinuation of treatment due to adverse events.

4 study duration

The study is estimated to conclude by October 7, 2025.

Participants continue to receive the medication until the study’s end date, unless otherwise advised by the study team.

Who Can Join the Study?

  • The patient must currently be taking a specific combination tablet called DOR/ISL in a clinical study and have completed the last treatment visit.
  • The patient should be considered by the study doctor to have benefited from the DOR/ISL treatment and should continue to need this treatment.
  • The patient can be male or female and must weigh at least 35 kg (about 77 pounds) at the time of agreeing to participate in the study.
  • If the patient is female, she must not be pregnant or breastfeeding. She must meet at least one of the following conditions:
    • She is not able to have children.
    • If she can have children, she agrees to either not be sexually active or use a reliable method of birth control during the study and for at least 6 weeks after the last dose of the study medication.
    • If she is pregnant, she may continue with the study treatment if allowed by local rules and based on available information or local care guidelines.

Who Cannot Join the Study?

  • Individuals who do not have an HIV infection cannot participate. HIV infection is a condition caused by the human immunodeficiency virus, which affects the immune system.
  • Participants must be within certain age ranges, specifically those categorized as age range 4 and 3. This typically refers to specific age groups defined by the study.
  • Both male and female participants are eligible, but those who do not fit these categories may be excluded.
  • Individuals from a vulnerable population are not selected for this study. A vulnerable population includes groups who may have limited ability to protect their own interests.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nice Nice France
Hopital Beaujon Clichy France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
04.11.2021
Italy Italy
Not recruiting
04.11.2021

Trial locations

Investigated drugs:

Doravirine is a medication used to treat HIV-1 infection. It works by blocking a specific enzyme that the virus needs to multiply, helping to control the infection and improve the immune system.

Islatravir is another medication used in the treatment of HIV-1 infection. It helps to prevent the virus from multiplying by interfering with its ability to replicate, which aids in managing the infection and maintaining immune function.

Investigated diseases:

HIV infection – Human Immunodeficiency Virus (HIV) infection is a condition caused by a virus that attacks the immune system, specifically targeting CD4 cells, which are crucial for fighting infections. Over time, if untreated, HIV can weaken the immune system, making the body more susceptible to other infections and diseases. The virus is primarily transmitted through contact with infected bodily fluids, such as blood, semen, vaginal fluids, and breast milk. In the early stages, individuals may experience flu-like symptoms, but as the infection progresses, it can lead to more severe health issues. Without intervention, HIV can advance to Acquired Immunodeficiency Syndrome (AIDS), where the immune system is severely compromised. Regular monitoring and management are essential to control the progression of the disease.

Trial ID:
2024-512215-53-00
Protocol code:
MK-8591A-033
Trial Phase:
Therapeutic confirmatory (Phase III)

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