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Study on the Effectiveness of Doravirine, Tenofovir Disoproxil, and Lamivudine in HIV Patients with M184V/I Mutation and Controlled Viral Load

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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 effectiveness of a medication combination for people living with HIV, a virus that attacks the body's immune system. The study involves a combination of three drugs: Lamivudine, Doravirine (also known by its code name MK-1439), and Tenofovir Disoproxil. These drugs are combined into a single tablet called Delstrigo, which is taken orally. The study is particularly interested in individuals who have a specific mutation known as M184V/I in their virus history and are currently managing their viral load effectively.

The purpose of the study is to evaluate how well this drug combination works over a period of 24 weeks in maintaining control over the virus in participants with a history of the M184V/I mutation. Participants will take the medication daily and will be monitored to see if their viral load remains undetectable, meaning the virus is not found in their blood at a level that can be measured. The study will also look at the participants' health over a longer period, up to 48 weeks, to gather more information about the treatment's effectiveness and any changes in their health status.

Throughout the study, participants will have regular check-ups to monitor their health, including blood tests to measure the virus levels and other health indicators. The study aims to provide valuable insights into the use of this medication combination for people living with HIV who have a history of the M184V/I mutation, helping to improve treatment strategies for managing the virus effectively.

The research process

The trial runs in 4 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, the patient must meet specific criteria, including being an adult living with HIV-1, having a stable antiretroviral treatment for at least 3 months, and maintaining an HIV RNA viral load of less than 50 copies per milliliter for at least 6 months.

    The patient must have a history of the M184V/I mutation in a previous genotype but not in the current proviral DNA. Complete sensitivity to doravirine and tenofovir must be confirmed according to the genotype of the proviral DNA.

  2. Step 2

    Medication administration

    The patient will receive a combination of doravirine, tenofovir disoproxil fumarate, and lamivudine in the form of Delstrigo 100 mg/300 mg/245 mg film-coated tablets.

    The medication is administered orally once daily for a duration of 24 weeks.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, the patient's viral load will be monitored to ensure it remains undetectable. The primary endpoint is the proportion of patients with an undetectable viral load at 24 weeks.

    Secondary assessments include monitoring the viral load at 48 weeks, changes in the NGS genotype on proviral DNA, CD4 count, weight, lipid levels (LDL, HDL, triglycerides, and total cholesterol), and quality of life (QoL) using the SF36 questionnaire.

  4. Step 4

    Completion of the trial

    The trial is expected to conclude by March 1, 2026. Upon completion, the data collected will be analyzed to determine the efficacy of the medication combination in maintaining an undetectable viral load in patients with a history of the M184V/I mutation.

Who can join the trial?

6 criteria

  • The patient must be an adult living with HIV-1.
  • The patient should have been on a stable antiretroviral treatment for at least 3 months. This means they have been taking their HIV medication regularly without changes.
  • The patient's HIV RNA VL (viral load) must be less than 50 copies per milliliter for at least 6 months. This indicates that the virus is well controlled in their body.
  • The patient must have had the M184V/I mutation in at least one previous test on their blood, but it should not be present in the current test on their proviral DNA. This mutation is a change in the virus that can affect how it responds to treatment.
  • The patient must have signed an informed consent form, which means they agree to participate in the study and understand what it involves.
  • At the time of joining the study, the patient must show complete sensitivity to the medications doravirine and tenofovir based on their current proviral DNA test. This means these medications should still be effective for them.

Who cannot join the trial?

7 criteria

  • Patients who are not living with HIV-1. HIV-1 is a type of virus that affects the immune system.
  • Patients who are not virologically controlled. This means the virus is not being effectively managed or kept at low levels in the body.
  • Patients who do not have an M184V/I mutation in a previous genotype. This refers to specific changes in the virus's genetic material that were identified in past tests.
  • Patients who have the M184V/I mutation present on the current proviral DNA. Proviral DNA is the form of the virus's genetic material that is integrated into the patient's cells.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not considered part of the vulnerable population selected for the study.
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Investigated drugs

  • Doravirine

    is a medication used to help control HIV infection. It works by decreasing the amount of HIV in the body, which helps the immune system work better. This can reduce the risk of getting HIV-related complications and improve the quality of life for people living with HIV.

  • Tenofovir Disoproxil Fumarate

    (TDF) is another medication used in the treatment of HIV. It helps to lower the amount of HIV in the blood and is often used in combination with other HIV medications to enhance its effectiveness.

  • Lamivudine

    is a medication that is also used to treat HIV infection. It works by blocking the virus from multiplying, which helps to reduce the amount of virus in the body. Lamivudine is commonly used in combination with other HIV medications to improve treatment outcomes.

What is already known about the treatment

  • Doravirine

    Doravirine is an oral medication used in combination with other drugs to treat HIV-1 infection in patients who are virologically controlled and have a history of the M184V/I mutation. It is currently being studied in clinical trials to assess its efficacy in this specific patient group. Doravirine works by inhibiting the action of reverse transcriptase, an enzyme necessary for the replication of HIV, thereby reducing the viral load in the body. It is classified as a non-nucleoside reverse transcriptase inhibitor (NNRTI).

  • Tenofovir Disoproxil Fumarate

    Tenofovir Disoproxil Fumarate (TDF) is an oral medication used as part of combination therapy for treating HIV-1 infection. It is being evaluated in clinical trials for its effectiveness in patients with a history of the M184V/I mutation who are virologically controlled. TDF works by blocking the reverse transcriptase enzyme, which is crucial for the HIV virus to multiply. It belongs to the class of drugs known as nucleotide reverse transcriptase inhibitors (NRTIs).

  • Lamivudine

    Lamivudine is an oral medication used in combination with other antiretroviral drugs to treat HIV-1 infection. It is currently under investigation in clinical trials for its role in patients with a history of the M184V/I mutation who are virologically controlled. Lamivudine acts by inhibiting the reverse transcriptase enzyme, preventing the virus from replicating. It is classified as a nucleoside reverse transcriptase inhibitor (NRTI).

Investigated diseases

HIV-1 Infection – HIV-1 is a virus that attacks the immune system, specifically targeting CD4 cells, which are crucial for immune defense. Over time, the virus can destroy so many of these cells that the body becomes unable to fight off infections and diseases. The progression of HIV-1 infection can be divided into several stages, starting with acute infection, followed by clinical latency, and eventually leading to acquired immunodeficiency syndrome (AIDS) if untreated. During the acute phase, individuals may experience flu-like symptoms, while the latency stage can last for several years with few or no symptoms. As the disease progresses, the immune system weakens, making the body more susceptible to opportunistic infections and certain cancers. The presence of specific mutations, such as M184V/I, can affect the virus's resistance to certain medications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505845-17-00Protocol codeDrive Off RoadEstimated enrolment32 patientsSponsorCentre Hospitalier Universitaire De Caen Normandie

sourced from the EU Clinical Trials Register and site verification

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