Study of Rilpivirine for Children and Teens with HIV-1 from Previous Rilpivirine Studies

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What is this study about?

This clinical trial is focused on studying the treatment of HIV-1 infection, a virus that attacks the immune system. The study involves the use of a medication called rilpivirine, which is also known by its code name TMC278. Rilpivirine is taken orally in the form of a tablet. The purpose of this study is to provide continued access to rilpivirine for participants who have previously been treated with it in earlier pediatric studies and have experienced benefits from its use.

Participants in this study will continue to take rilpivirine along with other medications that help manage HIV-1. The study is designed to ensure that those who have been benefiting from rilpivirine can keep receiving it. The treatment period in this study can last up to 120 days. During this time, participants will be monitored to ensure they continue to experience positive effects from the medication.

This study is open-label, meaning that both the participants and the researchers know which treatment is being administered. There is no primary endpoint defined for this study, which means it is primarily focused on providing ongoing treatment rather than measuring specific outcomes. Participants will continue to receive rilpivirine as long as they are benefiting from it, according to the judgment of the study investigators.

1 joining the study

Upon joining the study, an Informed Consent Form must be signed. This form indicates understanding of the study’s purpose and procedures. For children capable of understanding, typically 7 years and older, assent is also required.

2 eligibility confirmation

Eligibility is confirmed by ensuring the participant is HIV-1 infected and has previously been treated with rilpivirine 25 mg once daily (or a weight-adjusted dose) in a prior pediatric study. The participant must have completed the treatment period defined by that study’s protocol.

The participant must be benefiting from the treatment with rilpivirine according to the criteria set in the previous study and is expected to continue benefiting from it.

3 treatment continuation

The study provides continued access to rilpivirine in combination with other antiretrovirals. The medication is administered orally in the form of a tablet.

The dosage is 25 mg once daily, or adjusted based on weight, as previously determined in the pediatric study.

4 ongoing participation

Participants must be able and willing to comply with the study’s protocol requirements. The general medical condition should not interfere with participation, as assessed by the investigator.

5 study duration

The estimated end date for the study is April 30, 2026. Participants will continue to receive treatment and be monitored until this date, unless otherwise specified by the study protocol.

Who Can Join the Study?

The patient or their legal representative must sign an Informed Consent Form (ICF), which means they agree to join the study and understand what it involves. If the patient is a child who can understand the study (usually 7 years or older), they must also agree.
The patient must have an HIV-1 infection and have been treated with a specific dose of a medicine called RPV in a previous study for children. They must have completed the treatment period in that study.
The patient must be benefiting from the RPV treatment based on the results and safety guidelines from the previous study. The doctor must also believe that the patient will continue to benefit from this treatment.
The patient must be able and willing to follow the rules and requirements of the current study.
The patient’s overall health condition should not prevent them from participating in the study, according to the doctor.

Who Cannot Join the Study?

Patients who have not been treated with RPV (a medication used in the treatment of HIV-1 infection) in a previous pediatric study.
Patients who are not experiencing or are not expected to continue experiencing clinical benefits from RPV treatment.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

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

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	12.01.2021

Trial locations

Investigated drugs:

Rilpivirine

Rilpivirine is a medication used in the treatment of HIV-1 infection. It is part of a group of drugs known as antiretrovirals, which help to control the virus in the body. In this clinical trial, rilpivirine is being provided to participants who have previously been treated with it in pediatric studies and have shown clinical benefits from its use. The goal is to continue providing this medication to help manage their HIV-1 infection effectively.

Background Regimen Containing Other Antiretrovirals (ARVs) refers to a combination of other antiretroviral medications that are used alongside rilpivirine. These medications work together to help control the HIV-1 virus in the body. The specific drugs in this regimen can vary, but they are chosen to complement rilpivirine and enhance its effectiveness in treating the infection.

HIV-1 Infection – HIV-1 infection is caused by the human immunodeficiency virus type 1, which attacks the immune system, specifically targeting CD4 cells. Over time, the virus reduces the number of these cells, weakening the body’s ability to fight infections and diseases. Initially, individuals may experience flu-like symptoms, but as the infection progresses, it can lead to more severe immune system damage. Without intervention, the infection can advance to acquired immunodeficiency syndrome (AIDS), where the immune system is severely compromised. The progression of the disease varies among individuals, and it can remain in a latent stage for many years. Regular monitoring and management are essential to control the virus’s impact on the body.

Trial ID:

2024-512889-33-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Rilpivirine for Children and Teens with HIV-1 from Previous Rilpivirine Studies

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?