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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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, which are taken as a single pill once a day. The other group will receive a different combination of medications known as bictegravir, emtricitabine, and tenofovir alafenamide, also taken as a single pill once a day. These medications are designed to help control the virus in people who have not previously received antiretroviral therapy, which is the standard treatment for HIV.

The purpose of this study is to compare the effectiveness, safety, and tolerability of the two treatment options over a period of time. Participants will be randomly assigned to one of the two groups and will not know which treatment they are receiving, as the study is double-blind. This means that neither the participants nor the researchers will know who is receiving which treatment, to ensure unbiased results. The study will last for a total of 96 weeks, with regular check-ups and assessments to monitor the participants' health and the virus's response to the treatment.

Throughout the study, the main focus will be on how well the treatments reduce the amount of HIV-1 RNA in the blood, which is a measure of the virus's activity. Safety will also be closely monitored by reviewing any side effects or adverse events that participants may experience. The study aims to provide valuable information on the best treatment options for people newly diagnosed with HIV-1, helping to improve their health outcomes and quality of life.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be randomly assigned to one of two groups. This means you will either receive the combination of doravirine and islatravir or the combination of bictegravir, emtricitabine, and tenofovir alafenamide. This assignment is done by chance, like flipping a coin.

  2. Step 2

    Medication administration

    If you are in the group receiving doravirine and islatravir, you will take a film-coated tablet containing 100 mg of doravirine and 0.25 mg of islatravir once daily by mouth.

    If you are in the group receiving bictegravir, emtricitabine, and tenofovir alafenamide, you will take a film-coated tablet containing 50 mg of bictegravir, 200 mg of emtricitabine, and 25 mg of tenofovir alafenamide once daily by mouth.

  3. Step 3

    Duration of treatment

    You will continue taking the assigned medication daily for a period of 48 weeks. During this time, your health and response to the medication will be closely monitored.

  4. Step 4

    Regular check-ups

    Throughout the study, you will have regular check-ups to monitor your health and the effectiveness of the treatment. These check-ups will include blood tests to measure the amount of HIV-1 in your blood and to check your overall health.

  5. Step 5

    End of study evaluation

    At the end of the 48-week period, a final evaluation will be conducted to assess the effectiveness and safety of the treatment. This will include a review of your health records and any side effects you may have experienced.

Who can join the trial?

4 criteria

  • The person must be at least 18 years old and can be of any sex or gender.
  • The person must have HIV-1 and a certain level of the virus in their blood, specifically 500 copies/mL or more at the time of screening.
  • The person must not have taken any antiretroviral therapy (ART) before. This means they have not used any medication to treat their HIV-1 infection.
  • 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 trial?

5 criteria

  • Patients who are not infected with 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 cannot participate. The age range includes adults and older adults.
  • Patients who are not part of the specified clinical trial groups cannot participate. This refers to specific categories or groups that the study is focusing on.
  • Patients who are not male or female cannot participate. The study includes both male and female participants.
  • Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups that need special protection.
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Investigated drugs

  • Doravirine/Islatravir

    is a combination of two medications used to treat HIV-1 infection. Doravirine helps to block the virus from multiplying in the body, while Islatravir works by interfering with the virus's ability to reproduce. Together, they help to lower the amount of HIV in the blood, which can improve the immune system and reduce the risk of developing HIV-related illnesses.

  • Bictegravir/Emtricitabine/Tenofovir Alafenamide

    is another combination medication used in the treatment of HIV-1 infection. Bictegravir helps to prevent the virus from multiplying, while Emtricitabine and Tenofovir Alafenamide work by blocking the virus's ability to reproduce. This combination helps to reduce the amount of HIV in the blood, supporting the immune system and decreasing the likelihood of HIV-related health issues.

What is already known about the treatment

Doravirine/Islatravir – This medication is taken orally in the form of a pill and is currently being studied in clinical trials for its effectiveness in treating HIV-1 infection. It is not yet widely available in medical practice as it is still under investigation. The main purpose of this medication is to help control HIV-1 infection in people who have not received treatment before. At the molecular level, Doravirine works by blocking a key enzyme that the virus needs to multiply, while Islatravir interferes with the virus's ability to replicate its genetic material. This combination belongs to the class of antiretroviral drugs, which are used to manage HIV 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. The virus replicates within these cells, leading to their gradual depletion. As the infection progresses, the immune system becomes increasingly compromised, making the body more susceptible to opportunistic infections and certain cancers. The progression of HIV-1 infection can vary, but without intervention, it typically advances through stages, starting from acute infection to chronic infection, and eventually to acquired immunodeficiency syndrome (AIDS). During the chronic phase, the virus continues to multiply at lower levels, often without symptoms, but it can still be transmitted to others. Over time, the persistent viral activity and immune system damage can lead to significant health issues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502099-22-00Protocol codeMK-8591A-053Estimated enrolment581 patientsSponsorMerck Sharp & Dohme LLC

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