Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on HIV Treatment Interruption in Children with Perinatal HIV Using Lamivudine and Drug Combination

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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, specifically in individuals who acquired the infection at birth. The study will explore various medications used in antiretroviral therapy, which is a treatment designed to manage HIV infection. The medications being studied include Lamivudine, Darunavir, Cobicistat (also known as GS-9350), Emtricitabine, Tenofovir Alafenamide, Dolutegravir (also known as GSK1349572), Rilpivirine (also known as TMC278), Abacavir, and Bictegravir (also known as GS-9883). Some participants will receive a placebo as part of the study.

The purpose of the study is to understand how the HIV virus behaves in the body and to find new ways to manage the infection by temporarily stopping antiretroviral therapy. This is done to see if the virus remains under control without continuous medication. The study will involve monitoring the virus and the immune system's response during this period. Participants will be selected based on specific criteria, and their health will be closely monitored throughout the study.

The study will last for a period of up to 48 weeks, during which participants will undergo regular check-ups and tests to assess the effects of stopping and restarting their medication. The goal is to gather information that could lead to better treatment strategies for managing HIV in the future. Participants will be carefully monitored to ensure their safety and well-being throughout the study.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and laboratory tests to ensure specific health criteria are met.

  2. Step 2

    Medication regimen

    Participants will continue their current regimen of at least three antiretroviral drugs. These medications are taken orally and include combinations such as lamivudine, darunavir, cobicistat, emtricitabine, tenofovir alafenamide, dolutegravir, abacavir, and rilpivirine.

  3. Step 3

    Monitoring phase

    Regular monitoring is conducted to assess the health status and response to the medication. This includes blood tests to measure the levels of HIV and immune cell counts.

  4. Step 4

    Treatment interruption

    Eligible participants may undergo a planned interruption of antiretroviral treatment. This phase is closely monitored to observe the body's response to the absence of medication.

  5. Step 5

    Evaluation of viral rebound

    During the treatment interruption, the study evaluates the time it takes for the HIV virus to rebound to a detectable level. This helps in understanding the virus's behavior without medication.

  6. Step 6

    Re-initiation of treatment

    If the virus rebounds to a certain level, or if health criteria are met, antiretroviral treatment is re-initiated. The response to restarting medication is carefully monitored.

  7. Step 7

    Final assessment

    A final assessment is conducted to evaluate the overall health and outcomes of the study. This includes a review of any changes in the viral reservoir and immune function.

Who can join the trial?

10 criteria

  • Participants must be **12 years old or older**.
  • Participants must have an **HIV-1 infection**.
  • Participants or their caregivers must provide **written informed consent**. This means they agree to join the study after understanding what it involves.
  • Participants must have certain **laboratory values** at the start of the study:
    • **Hemoglobin** level greater than 11.5 g/dL. Hemoglobin is a protein in red blood cells that carries oxygen.
    • **Absolute neutrophil count** of at least 1000/mm3. Neutrophils are a type of white blood cell important for fighting infections.
    • **Platelet count** of at least 100,000/mm3. Platelets help with blood clotting.
    • Participants must have been on the same **antiretroviral therapy (ART)** regimen, which is a treatment for HIV, with 3 or more drugs for at least 1 year.
    • Participants must have a **CD4+ cell count** of at least 200 cells/mm3 at the start of the study. CD4+ cells are a type of white blood cell that helps the immune system.
    • Participants must have a record of **HIV-1 RNA** levels that are below the detection limit of an approved test at least once between 12 and 24 months before the study, and once less than 12 months before the study. HIV-1 RNA is a measure of the virus in the blood.
    • Participants must be willing to **interrupt their ART** if they are adults, or both the caregiver and adolescent must agree to this.

Who cannot join the trial?

5 criteria

  • Individuals who do not have a **perinatally HIV infection**. This means the person must have been infected with HIV around the time of birth.
  • Individuals who do not fit within the specific age ranges required for the study. The study is looking for participants within certain age groups.
  • Individuals who are not part of the specific clinical trial groups needed for the study. This means the study is looking for people with certain characteristics or conditions.
  • Individuals who are not willing or able to follow the study procedures and requirements.
  • Individuals who have any other medical conditions or factors that the study team believes would make participation unsafe or inappropriate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Antiretroviral Therapy (ART)

    This is a treatment used to manage HIV infection. It involves taking a combination of HIV medicines every day. ART helps to reduce the amount of virus in the body, maintain the function of the immune system, and prevent the progression to AIDS. In this study, ART is used to control the HIV infection and is interrupted to study the effects on the viral reservoir and immune response.

  • Analytical Antiretroviral Treatment Interruption (ATI)

    This is a planned and temporary stop of antiretroviral therapy under close medical supervision. The purpose of ATI in this study is to observe how the virus behaves when treatment is paused, particularly focusing on the viral rebound and changes in the immune system. This helps researchers understand the dynamics of the HIV reservoir and the potential for achieving a functional cure.

What is already known about the treatment

Antiretroviral Therapy (ART) – This medication is administered orally and is used in the treatment of perinatally acquired HIV infection. Currently, ART is well-established in medical practice and literature as a cornerstone in managing HIV, aiming to suppress the virus and prevent disease progression. The main therapeutic indication is to control HIV infection, reducing viral load and improving immune function. At the molecular level, ART works by inhibiting the replication of the HIV virus, targeting various stages of its life cycle, such as reverse transcription and integration into the host genome. It is classified pharmacologically as an antiretroviral agent, encompassing several drug classes like reverse transcriptase inhibitors and protease inhibitors.

Investigated diseases

Perinatally Acquired HIV Infection – This condition occurs when a child is infected with the Human Immunodeficiency Virus (HIV) during pregnancy, childbirth, or breastfeeding. The virus attacks the immune system, specifically targeting CD4 cells, which are crucial for fighting infections. Over time, the immune system becomes weakened, making the body more susceptible to other infections and diseases. In children, the progression can vary, with some experiencing rapid progression to AIDS, while others may have a slower course. The virus can remain dormant in the body, forming a reservoir that can reactivate, leading to increased viral replication. Monitoring and managing the viral load and immune function are essential aspects of understanding the disease's progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518694-33-00Protocol codeITACO_2780_OPBG_2022Estimated enrolment61 patientsSponsorOspedale Pediatrico Bambino Gesu

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

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).