Study on HIV-1 Treatment for Patients New to Therapy: Comparing Doravirine/Islatravir with a Drug Combination

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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 two different treatment groups. One group will receive a combination of medications called doravirine and islatravir, known together as MK-8591A. The other group will receive a combination of bictegravir, emtricitabine, and tenofovir alafenamide, which are combined in a medication called Biktarvy. The purpose of the study is to evaluate the effectiveness, safety, and tolerability of these treatments in people who have not previously taken antiretroviral therapy, which is a type of medication used to treat HIV.

Participants in the study will be randomly assigned to one of the two treatment groups. The study is designed to be double-blind, meaning neither the participants nor the researchers will know which treatment each participant is receiving. This helps to ensure that the results are not biased. The study will last for a period of 96 weeks, with regular check-ups to monitor the participants’ health and the effectiveness of the treatment. The main goal is to see how well the treatments can reduce the amount of HIV in the blood to very low levels, specifically less than 50 copies per milliliter, by Week 48.

Throughout the study, the safety and side effects of the treatments will be closely monitored. Participants will have regular visits with healthcare professionals to review their health status and any potential side effects. The study will also look at changes in the participants’ immune system, specifically the number of CD4+ T-cells, which are a type of white blood cell that plays a crucial role in the immune response. The study aims to provide valuable information on the best treatment options for people living with HIV-1 who are new to antiretroviral therapy.

1 joining the study

Upon joining the study, the participant is confirmed to be HIV-1 positive and has not received any prior antiretroviral therapy. The participant is at least 18 years old and meets other eligibility criteria.

2 randomization

The participant is randomly assigned to one of two groups. One group receives a combination of doravirine and islatravir (DOR/ISL 100 mg/0.25 mg) once daily. The other group receives a combination of bictegravir, emtricitabine, and tenofovir alafenamide (BIC/FTC/TAF 50 mg/200 mg/25 mg) once daily.

3 treatment administration

The participant takes the assigned medication orally in the form of film-coated tablets. The medication is taken once daily for the duration of the study.

4 monitoring and assessments

Throughout the study, the participant’s health is monitored regularly. This includes checking the levels of HIV-1 RNA in the blood to assess the effectiveness of the treatment. The goal is to achieve less than 50 copies/mL of HIV-1 RNA by Week 48.

Safety and tolerability are also evaluated by reviewing any adverse events experienced by the participant.

5 follow-up evaluations

At Week 48, the primary evaluation of the treatment’s effectiveness and safety is conducted. Secondary evaluations occur at Weeks 96 and 144 to assess long-term outcomes, including changes in CD4+ T-cells and body weight.

6 completion of the study

The study is estimated to conclude by August 6, 2029. The participant’s involvement continues until the study’s end, unless they choose to discontinue earlier due to adverse events or other reasons.

Who Can Join the Study?

  • The person must be 18 years or older and can be of any sex or gender.
  • The person must have HIV-1, which is a type of virus, and have a certain amount of the virus in their blood, specifically 500 copies/mL or more at the time of screening.
  • The person must be new to antiretroviral therapy (ART), meaning they have not received any treatment for HIV-1 since being diagnosed.
  • If the person is a female who can have children, she must not be pregnant or breastfeeding. She must also agree to use a reliable method of birth control or not have heterosexual intercourse during the study.

Who Cannot Join the Study?

  • Individuals who do not have an HIV-1 infection cannot participate. HIV-1 is a type of virus that affects the immune system.
  • Participants must be within the specified age range, which is not detailed here, but typically means they must be adults or older teenagers.
  • Both males and females are eligible, so gender is not a reason for exclusion.
  • Individuals who are part of a vulnerable population, such as those unable to give consent or those with certain disabilities, are not excluded based on this information.

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

Other Sites

Site Name City Country Status
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire De Nice Nice France
Hopitaux Universitaires Pitie Salpetriere Paris France
Centre Hospitalier De Tourcoing Tourcoing France
Assistance Publique Hopitaux De Paris Paris France
Ludwig Maximilian University Of Munich Munich Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
ICH Study Center GmbH & Co. KG Hamburg Germany
Assistance Publique Hopitaux De Paris Creteil France
Hospital Universitario Virgen De La Victoria Malaga Spain
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Umssmcolgd Mykumqh Cveeww Hlqzuwvurcxplucqr Hamburg Germany
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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 recruiting
01.03.2024
Germany Germany
Not recruiting
01.03.2024
Spain Spain
Not recruiting
01.03.2024

Trial locations

Doravirine/Islatravir (DOR/ISL) is a combination medication used in this clinical trial to treat individuals who are newly diagnosed with HIV-1. It is taken once daily and is being studied for its ability to reduce the amount of HIV in the blood, as well as its safety and how well it is tolerated by patients.

Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) is another combination medication used in the trial as a comparison to DOR/ISL. This medication is also used to treat HIV-1 and is taken once daily. The trial aims to compare its effectiveness in reducing HIV levels in the blood and its safety profile to that of DOR/ISL.

HIV-1 Infection – HIV-1 infection is caused by the human immunodeficiency virus type 1, which attacks the immune system, specifically targeting CD4+ T-cells. As the virus replicates, it reduces the number of these cells, weakening the body’s ability to fight off infections and diseases. The progression of the infection can vary, but without intervention, it typically leads to a significant decline in immune function. Over time, this can result in the development of acquired immunodeficiency syndrome (AIDS), characterized by severe immune system damage. The virus is primarily transmitted through contact with infected bodily fluids, such as blood, semen, and vaginal fluids. Regular monitoring of viral load and CD4+ T-cell count is crucial in managing the infection.

Trial ID:
2022-502099-22-01
Protocol code:
MK-8591A-053
NCT ID:
NCT05705349
Trial Phase:
Therapeutic confirmatory (Phase III)

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