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Study on Early Switching to Dolutegravir and Lamivudine for Adults with HIV-1 on Three-Drug Regimen with Virological Suppression

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 adults with HIV-1, a virus that attacks the immune system. The study involves participants who are currently taking a three-drug regimen that includes an integrase strand transfer inhibitor (INSTI) and have successfully reduced their viral load to very low levels. The trial will explore the effects of switching to a two-drug regimen using a single pill called Dovato, which contains the active substances lamivudine and dolutegravir sodium.

The purpose of the study is to evaluate the effectiveness and safety of this early switch to the two-drug regimen compared to continuing the current three-drug treatment. Participants will be monitored over a period of 96 weeks. Initially, the study will focus on the first 48 weeks to see if the new regimen maintains viral suppression. After this period, those in the control group will also switch to the two-drug regimen, and the final evaluation will occur at the end of the study.

Throughout the study, various health parameters will be assessed, including changes in immune cell counts, the presence of any drug resistance, and overall safety. The study will also look at changes in metabolic health, mental health, and quality of life. Participants will undergo regular check-ups to ensure their well-being and to gather data on the effectiveness of the treatment switch.

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

    Initial assessment

    Eligibility is confirmed based on specific criteria, including documented HIV-1 infection, age over 18 years, and a stable first-line treatment with an integrase strand transfer inhibitor (INSTI)-based three-drug regimen for less than 18 months.

    A recent virological suppression with HIV-1 RNA levels below 50 copies/mL is required, along with a negative hepatitis B surface antigen test within the last 18 months.

  2. Step 2

    Treatment initiation

    Participants begin taking Dovato, a combination of lamivudine and dolutegravir sodium, in the form of a single film-coated tablet.

    The medication is administered orally once daily.

  3. Step 3

    Follow-up and monitoring

    Participants are monitored for virological response, with primary focus on maintaining HIV-1 RNA levels below 50 copies/mL at week 48.

    Regular assessments include changes in CD4+ and CD8+ T-lymphocyte counts, and monitoring for any resistance mutations.

  4. Step 4

    Interim analysis

    An exploratory interim analysis is conducted after 50% of participants have completed 24 weeks of follow-up.

    This analysis evaluates the proportion of participants with virological rebound, defined as HIV-1 RNA levels of 50 copies/mL or higher.

  5. Step 5

    Continuation and final evaluation

    Participants continue the treatment for a total of 96 weeks.

    After 48 weeks, those in the control group switch to the two-drug regimen with Dovato.

    The final evaluation occurs at the end of the 96-week period, assessing long-term efficacy and safety.

Who can join the trial?

10 criteria

  • Must have a documented infection with HIV-1, which is a type of virus that affects the immune system.
  • Must be at least 18 years old.
  • Must have been treated with ART (antiretroviral therapy) for less than 18 months before the start of the study. ART is a treatment that helps control HIV.
  • Must be on a stable first-line treatment that includes three drugs, one of which is an INSTI (integrase strand transfer inhibitor). This means the treatment has not changed recently. INSTIs are a type of medication used to treat HIV.
  • Must have achieved a level of HIV-1 RNA (the virus's genetic material) of less than 50 copies per milliliter in the blood during the first-line therapy for less than 12 months. This indicates that the virus is well-controlled.
  • Must have at least one test result showing HIV-1 RNA below 50 copies per milliliter within the 6 months before joining the study. If there is a later test, it should not show more than 50 copies per milliliter.
  • Must have a negative test for HbsAg (Hepatitis B surface antigen) within 18 months before the study. This means they do not have an active Hepatitis B infection.
  • Must not have any known allergies or intolerances to NRTIs (nucleoside reverse transcriptase inhibitors) or INSTIs. These are types of medications used to treat HIV.
  • Must be able to follow the study's requirements.
  • Must have signed an informed consent form, which means they understand the study and agree to participate.

Who cannot join the trial?

6 criteria

  • Individuals who have not been taking an INSTI-based (a type of HIV medication) three-drug first-line treatment for less than 18 months.
  • Individuals who have not achieved or maintained a recent virological suppression (keeping the virus at very low levels) with HIV-1 RNA less than 50 copies/mL.
  • Individuals who are not within the specified age range for the study.
  • Individuals who are not part of the specified clinical trial groups.
  • Individuals who are not male or female, as both genders are included in the study.
  • Individuals who are not considered part of a vulnerable population.
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Investigated drugs

Dolutegravir/Lamivudine (DTG/3TC) is a combination medication used in the treatment of HIV-1 infection. It combines two active ingredients, dolutegravir and lamivudine, into a single pill. Dolutegravir is an integrase inhibitor that helps prevent the virus from multiplying in the body, while lamivudine is a reverse transcriptase inhibitor that also works to stop the virus from spreading. This combination is used as a two-drug regimen for patients who have already achieved viral suppression with a three-drug regimen. The goal is to maintain viral suppression while potentially reducing the number of medications a patient needs to take.

What is already known about the treatment

Dolutegravir/Lamivudine (DTG/3TC) – This medication is administered orally as a single pill and is currently being studied for its efficacy and safety in treating HIV-1-infected individuals. It is specifically used for patients who have been virologically suppressed with an HIV-1 RNA count of less than 50 copies/mL and are switching from a three-drug regimen. The main therapeutic indication is for maintaining viral suppression in HIV-1-infected adults. At the molecular level, Dolutegravir works by inhibiting the integrase enzyme, preventing the virus from integrating its genetic material into the host cell's DNA, while Lamivudine inhibits reverse transcriptase, blocking the virus's ability to replicate. This combination is classified as an antiretroviral medication.

Investigated diseases

HIV-1 Infection – HIV-1 is a virus that attacks the immune system, specifically targeting CD4+ T cells, which are crucial for immune defense. Over time, the virus replicates and reduces the number of these cells, weakening the immune system and making the body more susceptible to infections and certain cancers. Initially, individuals may experience flu-like symptoms, but as the infection progresses, it can lead to more severe immune system damage. Without treatment, HIV-1 can advance to Acquired Immunodeficiency Syndrome (AIDS), where the immune system is severely compromised. The progression of the disease can vary greatly among individuals, influenced by factors such as viral load and immune response. Regular monitoring of viral load and immune function is essential in managing the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518909-18-00Protocol codeEDOLASEstimated enrolment440 patientsSponsorSocieta Italiana Di Malattie Infettive E Tropicali SIMIT

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