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Study on Dolutegravir and Lamivudine for Maintaining Viral Control in Children with HIV Aged 2 to Under 15 Years

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 children aged 2 to under 15 years who are living with HIV, a virus that affects the immune system. The study aims to evaluate the effectiveness of a treatment called DTG/3TC, which is a combination of two medications, dolutegravir sodium and lamivudine, in maintaining control over the virus. The trial will compare this treatment to another regimen that includes dolutegravir sodium plus two other medications known as NRTIs (nucleoside reverse transcriptase inhibitors), which are commonly used to treat HIV.

Participants in the study will take the medications orally, in the form of tablets, over a period of time. The goal is to see if the new combination of DTG/3TC is as effective as the current standard treatment in keeping the virus under control, which is referred to as "virological suppression." The study will monitor the children's health and the virus levels in their blood at various points, such as weeks 24, 48, and 96, to ensure the treatment is working effectively.

Throughout the study, researchers will also observe any side effects or changes in the children's health, including their immune system's response, any new symptoms, and overall well-being. The trial is designed to ensure that the new treatment is safe and effective for children with HIV, providing valuable information for future treatment options.

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

    Enrollment

    The trial begins with the enrollment of children aged 2 to under 15 years who have been diagnosed with HIV and have maintained viral suppression for at least the last six months.

    Eligibility criteria include a minimum weight of 6 kg. Girls who have reached menarche must have a negative pregnancy test at screening and randomization.

    A parent or legal guardian must provide informed consent, and the child must give informed assent if deemed capable by the clinician.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups. One group receives a combination of dolutegravir and lamivudine (DTG/3TC), while the other group receives dolutegravir plus two nucleoside reverse transcriptase inhibitors (NRTIs).

    The goal is to assess whether the DTG/3TC combination is as effective as the DTG plus 2 NRTIs in maintaining viral suppression.

  3. Step 3

    Treatment administration

    Participants take their assigned medication orally. The specific medications include Retrovir, Kivexa, Truvada, Ziagen, Combivir, Descovy, Triumeq, Dovato, and Epivir, depending on the group assignment.

    The dosage and frequency are determined by the trial protocol and are administered as film-coated tablets or hard capsules.

  4. Step 4

    Monitoring and assessments

    Participants undergo regular monitoring to assess viral load, with primary endpoints measured at weeks 48 and 96.

    Secondary endpoints include assessments of viral rebound, resistance mutations, and changes in CD4 counts, among others.

    Participants and caregivers complete questionnaires to evaluate adherence, acceptability, sleep, mood, and quality of life.

  5. Step 5

    Completion

    The trial is estimated to conclude by September 30, 2025.

    Final assessments will determine the proportion of children maintaining viral suppression and any changes in treatment due to adverse events or toxicity.

Who can join the trial?

7 criteria

  • The child must be infected with HIV-1 and have had the virus under control for at least the last 6 months before joining the study.
  • The child must be between the ages of 2 and less than 15 years old.
  • The child must weigh at least 6 kilograms.
  • If the child is a girl who has started menstruating, she must have a negative pregnancy test at the start and during the study.
  • If the girl is sexually active, she must agree to use very effective birth control methods.
  • A parent or legal guardian must be willing and able to give permission for the child to join the study, following the country's laws, and agree to follow the study's rules.
  • The child must be willing to agree to join the study if the doctor thinks they are old enough and able to understand the information about the study.

Who cannot join the trial?

4 criteria

  • Individuals who are not HIV-infected cannot participate. This means only those who have the Human Immunodeficiency Virus (HIV) are eligible.
  • Participants must be within a specific age range, which is not specified here, but generally means there are age limits for who can join.
  • Both male and female participants are allowed, so gender is not a reason for exclusion.
  • People who are considered part of a vulnerable population are not included. This usually refers to groups who might need special protection or care, like children or those with certain disabilities.
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Investigated drugs

  • DTG/3TC

    is a combination medication used in this trial to maintain control of HIV infection in children. It combines two active ingredients that work together to help keep the virus at low levels in the body, which is important for managing the infection and preventing it from causing harm.

  • DTG

    , also known as Dolutegravir, is a medication that helps control HIV by blocking an enzyme the virus needs to multiply. This helps reduce the amount of virus in the body and supports the immune system.

  • 3TC

    , also known as Lamivudine, is another medication that helps control HIV. It works by interfering with the virus's ability to replicate, which helps keep the virus at low levels in the body.

  • 2 NRTIs

    refers to two nucleoside reverse transcriptase inhibitors, which are a class of medications used to treat HIV. These medications work by blocking an enzyme the virus needs to multiply, helping to control the infection and maintain the health of the immune system.

What is already known about the treatment

Dolutegravir/Lamivudine (DTG/3TC) – This medication is administered orally in the form of a fixed-dose combination tablet. It is currently being studied in clinical trials for its effectiveness in maintaining viral suppression in children with HIV infection. The main therapeutic indication is for the treatment of HIV in children aged 2 to under 15 years. 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 from replicating. This combination is classified as an antiretroviral medication.

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 are crucial for fighting infections. Over time, HIV can destroy so many of these cells that the body can't fight off infections and disease. The progression of HIV can lead to Acquired Immunodeficiency Syndrome (AIDS), the most severe phase of HIV infection. During this phase, the immune system is badly damaged, and the body becomes vulnerable to opportunistic infections and certain cancers. HIV is transmitted through contact with certain body fluids from a person with HIV, most commonly during unprotected sex or through sharing injection drug equipment. Without treatment, HIV can gradually weaken the immune system, but with proper medical care, it can be controlled.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-520388-15-00Protocol codeD3 (Penta 21)Estimated enrolment386 patientsSponsorFondazione Penta Ets

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