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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Ospedale Pediatrico Bambino Gesu’	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.07.2023

Trial locations

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.

Investigated diseases:

Acute HIV infection

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 ID:

2024-518694-33-00

Protocol code:

ITACO_2780_OPBG_2022

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?