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Study Comparing Doravirine/Lamivudine and Dolutegravir/Lamivudine for HIV Patients with Controlled Viral Load on Three-Drug Regimens

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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, a virus that attacks the body's immune system. The study will compare two different two-drug combinations to see how well they maintain control over the virus in people who have already been successfully treated with a three-drug regimen. The first combination includes doravirine and lamivudine, while the second combination includes dolutegravir and lamivudine. Dolutegravir is also known by its code name GSK1349572.

The purpose of the study is to determine if these two-drug combinations can keep the virus under control as effectively as the current three-drug treatments. Participants in the study will take one of the two-drug combinations and will be monitored over a period of time to see if the virus remains suppressed. The study will last for about 48 weeks, with regular check-ups to monitor the participants' health and the effectiveness of the treatment.

Throughout the study, participants will have their blood tested to measure the amount of virus present and to check for any side effects. The study will also look at other health indicators, such as immune cell counts and metabolic markers, to ensure the treatments are safe and effective. The goal is to find a simpler treatment option that is just as effective as the current standard, making it easier for people living with HIV to manage their condition.

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

    Initiation of treatment

    Upon joining the study, the current three-drug regimen is replaced with a two-drug regimen. The options are either doravirine and lamivudine or dolutegravir and lamivudine. Both medications are taken orally.

    The purpose of this change is to maintain the suppression of the HIV virus in the blood.

  2. Step 2

    Regular monitoring

    Regular monitoring is conducted to ensure the effectiveness of the treatment. This includes checking the viral load in the blood at specific intervals.

    The primary goal is to avoid any increase in the viral load, defined as two consecutive measurements above 50 copies/mL.

  3. Step 3

    Scheduled assessments

    Assessments are scheduled at weeks 24, 48, 72, and 96. These include measuring drug levels in the blood, checking for any side effects, and evaluating immune cell counts.

    Additional assessments may include body weight, metabolic markers, and satisfaction with the treatment.

  4. Step 4

    Completion of study

    The study is expected to conclude by June 2028. At the end of the study, a final assessment will be conducted to evaluate the overall effectiveness and safety of the treatment regimen.

Who can join the trial?

6 criteria

  • Must be an adult aged 18 years or older.
  • Must be living with HIV-1, which is a type of virus that affects the immune system.
  • Must have a plasma viral load (pVL) of less than 50 copies/mL for at least 24 months. This means the amount of virus in the blood is very low.
  • Must be on a stable three-drug regimen for at least 12 months. This includes 2 NRTIs (nucleoside reverse transcriptase inhibitors) and 1 NNRTI (non-nucleoside reverse transcriptase inhibitor) or 1 INSTI (integrase strand transfer inhibitor) or 1 boosted PI (protease inhibitor).
  • Must be affiliated with the French Social Insurance.
  • Must have given written consent to participate in the study, meaning they agree to join the trial after understanding what it involves.

Who cannot join the trial?

5 criteria

  • Patients who do not have HIV cannot participate. HIV is a virus that affects the immune system.
  • Patients who are not currently on a three-drug regimen for HIV cannot participate. A three-drug regimen is a treatment plan that uses three different medications to control the virus.
  • Patients who have not achieved a suppressed HIV plasma viral load cannot participate. A suppressed viral load means the amount of virus in the blood is very low.
  • Patients who are under 18 years old cannot participate.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may need special protection or care.
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Investigated drugs

  • Doravirine

    is a medication used in combination with other drugs 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.

  • Lamivudine

    is another medication used to treat HIV infection. It is often combined with other antiretroviral drugs to help control the virus. Lamivudine helps to lower the amount of HIV in the blood, which can help the immune system function more effectively.

  • Dolutegravir

    is a medication used in combination with other antiretroviral drugs to treat HIV infection. It works by blocking a specific enzyme that the virus needs to multiply, thereby reducing the amount of virus in the body and helping the immune system to recover.

What is already known about the treatment

  • Doravirine/Lamivudine (DOR/3TC)

    This medication is administered orally in tablet form. It is currently being studied in clinical trials as a maintenance therapy for people living with HIV (PLWH) who have been successfully treated with a three-drug regimen. The main therapeutic indication is to maintain virological success in individuals with suppressed HIV plasma viral load. Doravirine works by inhibiting the reverse transcriptase enzyme, which is crucial for the replication of the HIV virus, while Lamivudine also targets the same enzyme, preventing the virus from multiplying. This combination falls under the pharmacological classification of antiretroviral agents.

  • Dolutegravir/Lamivudine (DTG/3TC)

    This medication is also administered orally in tablet form. It is being evaluated in clinical trials for its effectiveness as a maintenance therapy for individuals with HIV who have achieved viral suppression with a three-drug regimen. The primary therapeutic use is to sustain virological success in patients with controlled HIV viral load. Dolutegravir works by inhibiting the integrase enzyme, which is essential for the integration of viral DNA into the host cell's DNA, while Lamivudine inhibits the reverse transcriptase enzyme, preventing the virus from replicating. This combination is classified as antiretroviral agents.

Investigated diseases

Human Immunodeficiency Virus (HIV) Infection – HIV is a virus that attacks the body's immune system, specifically the CD4 cells (T cells), which help the immune system fight off infections. Over time, HIV can destroy so many of these cells that the body can't fight off infections and disease. The virus is transmitted through contact with certain body fluids of an infected person, most commonly during unprotected sex or through sharing needles. In the early stages, individuals may experience flu-like symptoms, but as the infection progresses, it can lead to more severe immune system damage. Without treatment, HIV can advance to Acquired Immunodeficiency Syndrome (AIDS), where the immune system is severely compromised. Regular monitoring of viral load and immune function is crucial in managing the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515793-27-01Protocol codeCREPATS 19Estimated enrolment408 patientsSponsorANRS Maladies Infectieuses Emergentes

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).