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Study on Doravirine and Raltegravir for Maintaining Viral Control in HIV Patients with Low Viral Load

Verified siteRegistered drugNo placebo
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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 Disease, specifically in patients who have a very low level of the virus in their blood due to their current treatment. The study will use a combination of two medications: Doravirine and Raltegravir. Doravirine is also known by its code name MK-1439, and Raltegravir is known as MK-0518. These medications are taken as film-coated tablets by mouth.

The purpose of the study is to evaluate how well the combination of Doravirine and Raltegravir can maintain the suppression of the virus in patients who are already successfully managing their HIV with other treatments. Participants will be monitored over a period of time to see if the virus remains suppressed. The study will also look at the health of the immune system by measuring certain types of cells in the blood, and it will assess the quality of life of the participants through questionnaires.

Throughout the study, participants will have regular check-ups to monitor their health and the effectiveness of the treatment. The study will also track any changes in the virus and any potential side effects of the medications. This research aims to provide more information on the effectiveness of this dual therapy in maintaining viral suppression in people living with HIV.

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

    Initial visit

    Upon joining the study, the first step involves an initial visit. During this visit, eligibility is confirmed based on specific criteria such as age, HIV-1 infection status, and current treatment regimen.

    A signed informed consent form is required to participate. This form ensures understanding of the study and agreement to participate.

  2. Step 2

    Treatment initiation

    Participants begin the study treatment with a combination of two medications: doravirine and raltegravir. These are taken as film-coated tablets.

    Doravirine is administered as a 100 mg tablet, and raltegravir is administered as a 600 mg tablet. Both medications are taken orally once daily.

  3. Step 3

    Regular follow-up visits

    Regular follow-up visits are scheduled to monitor health and the effectiveness of the treatment. These visits occur at specific intervals: day 0 (D0), week 24 (W24), week 48 (W48), week 72 (W72), and week 96 (W96).

    During these visits, various assessments are conducted, including blood tests to measure viral load and immune cell counts, as well as questionnaires to evaluate quality of life and treatment adherence.

  4. Step 4

    End of treatment evaluation

    At the end of the study period, an evaluation is conducted to assess the overall effectiveness of the treatment in maintaining viral suppression.

    The primary goal is to determine the proportion of participants who maintain a viral load below 50 copies/mL by week 48.

Who can join the trial?

9 criteria

  • Must be at least 18 years old.
  • Must have a documented infection with HIV-1.
  • Must have a CD4 count of at least 200 cells per cubic millimeter.
    (CD4 cells are a type of white blood cell that fights infection.)
  • Must be on a stable ART regimen with at least 2 drugs for at least 6 months.
    (ART stands for antiretroviral therapy, which is the treatment for HIV.)
  • Must have an HIV-RNA plasma viral load of 50 copies/mL or less during the last 18 months.
    (Viral load is the amount of HIV virus in the blood.)
  • Must not have taken doravirine before.
    (Doravirine is a medication used to treat HIV.)
  • Must not have resistance to doravirine or raltegravir.
    (Resistance means the virus is not affected by the medication.)
  • Must sign an informed consent form.
    (This means you agree to participate in the study and understand what it involves.)
  • Must be affiliated with a social insurance program.
    (This is a requirement for patients in certain regions.)

Who cannot join the trial?

7 criteria

  • Patients who are not currently diagnosed with HIV Disease.
  • Patients who are not already on a stable HIV treatment and have their virus under control.
  • Patients who are under 18 years old or over 65 years old.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of allergic reactions to the study medications.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are participating in another clinical trial.
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Investigated drugs

  • Doravirine

    is a medication used to help control HIV infection. It works by blocking a specific protein that the virus needs to multiply. By doing this, doravirine helps to lower the amount of HIV in the body, which can improve the immune system and reduce the chance of developing HIV-related illnesses.

  • Raltegravir

    is another medication used in the treatment of HIV. It works by interfering with an enzyme that the virus uses to insert its genetic material into human cells. This action helps to prevent the virus from multiplying and spreading, which can help maintain a low level of the virus in the body and support the immune system.

What is already known about the treatment

  • Doravirine

    Doravirine is a medication taken orally, usually in the form of a tablet, and is used to help control HIV infection. It is currently recognized in medical literature as part of a dual therapy approach for maintaining low levels of the virus in the blood of patients who are already on antiretroviral treatment. The main therapeutic indication for doravirine is the treatment of HIV-1 infection. At the molecular level, doravirine works by blocking a specific enzyme called reverse transcriptase, which the HIV virus needs to multiply. It is classified pharmacologically as a non-nucleoside reverse transcriptase inhibitor (NNRTI).

  • Raltegravir

    Raltegravir is administered orally, typically as a tablet, and is used in combination with other medications to manage HIV infection. It is well-documented in medical literature as an effective component of dual therapy for maintaining viral suppression in patients with HIV-1. The primary therapeutic use of raltegravir is to treat HIV-1 infection. On a molecular level, raltegravir inhibits an enzyme called integrase, which is crucial for the virus to insert its genetic material into the host's DNA. It belongs to the pharmacological class known as integrase strand transfer inhibitors (INSTIs).

Investigated diseases

HIV Disease – HIV Disease is caused by the human immunodeficiency virus, which attacks the body's immune system, specifically the CD4 cells (T cells). Over time, HIV can destroy so many of these cells that the body can’t fight off infections and disease. The progression of HIV varies among individuals and can be divided into three stages: acute HIV infection, clinical latency, and acquired immunodeficiency syndrome (AIDS). During the acute phase, individuals may experience flu-like symptoms as the virus rapidly multiplies. In the clinical latency stage, the virus is still active but reproduces at very low levels, and individuals may not have symptoms. If untreated, HIV can progress to AIDS, where the immune system is severely damaged, leading to increased vulnerability to opportunistic infections.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-513941-35-00Protocol codeCREPATS 10Estimated enrolment118 patientsSponsorCentre De Recherches Et D'Etudes Sur La Pathologie Tropicale Et Le Sida

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