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

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 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.

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

    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. Step 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. Step 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. Step 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. Step 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 trial?

5 criteria

  • 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 trial?

2 criteria

  • 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.
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Investigated drugs

  • 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.

What is already known about the treatment

Rilpivirine – Rilpivirine is administered orally in tablet form. It is currently used in medicine as part of combination therapy for treating HIV-1 infection, particularly in patients who have previously participated in pediatric studies involving this medication. The main therapeutic indication for rilpivirine is the treatment of HIV-1 infection. At the molecular level, rilpivirine works by inhibiting the reverse transcriptase enzyme, which is crucial for the replication of the HIV virus. It belongs to the pharmacological class of non-nucleoside reverse transcriptase inhibitors (NNRTIs).

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512889-33-00Estimated enrolment43 patientsSponsorJanssen Sciences Ireland Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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