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Study on HIV-1 Patients: Effects of Rilpivirine and Dolutegravir After Stopping Antiretroviral Therapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying HIV-1, a virus that causes AIDS, in patients who have been treated early with effective antiretroviral therapy. The study involves the use of two medications, Rilpivirine and Dolutegravir, which are combined to help manage the virus. These medications are taken orally, meaning they are swallowed in pill form. The purpose of the study is to explore the characteristics of the immune system and genetic factors in patients who have stopped their antiretroviral therapy, aiming to identify markers that can predict how well the virus is controlled after stopping the medication.

Participants in the study will have their immune and genetic profiles examined to understand how these factors might help control the virus without ongoing medication. The study will take place over a period of time, during which participants will be monitored to see how their bodies respond after stopping the treatment. The goal is to develop a predictive algorithm, which is a kind of formula, to help determine which patients might successfully control the virus without continuous medication.

Throughout the study, researchers will collect data on how well participants maintain control over the virus and their immune system's health, specifically looking at the stability of their CD4 T-cell count, which is an important measure of immune health. This research could lead to better understanding and management of HIV-1 in patients who have been treated early, potentially reducing the need for lifelong medication. The study is expected to conclude by mid-2025.

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 and initial assessment

    Upon joining the study, participants undergo an initial assessment to confirm eligibility. This includes verifying HIV-1 seropositive status, ensuring antiretroviral therapy (ART) was started during the acute phase of infection, and confirming a stable plasma HIV-RNA level below 50 copies/ml for at least 24 months.

    Participants must have a CD4+ T cell count greater than 350 cells/mm3 and no new AIDS-defining diagnoses. Written informed consent is required.

  2. Step 2

    Antiretroviral therapy interruption

    Participants who meet the eligibility criteria will undergo a planned interruption of their antiretroviral therapy. This phase is crucial for studying the body's response to the absence of medication.

    The therapy interruption is carefully monitored to observe the immune and virologic responses.

  3. Step 3

    Monitoring and data collection

    During the study, participants are regularly monitored to collect data on immune-genetic and viroimmunologic biomarkers. This involves periodic blood tests and health assessments.

    The primary goal is to complete immune-virologic and immune-genetic profiling within 21 months.

  4. Step 4

    Evaluation of post-treatment control

    The study aims to evaluate the proportion of participants who maintain control over viremia counts and a stable CD4 T-cell count after therapy interruption.

    Participants are observed for a period of 6 months to assess the stability of their CD4 T-cell count, ensuring it remains above 350 cells/μl.

  5. Step 5

    Completion and analysis

    At the end of the study, all collected data is analyzed to validate predictive algorithms for post-treatment control.

    The study is expected to conclude by June 30, 2025, with comprehensive statistical analysis performed on the gathered data.

Who can join the trial?

8 criteria

  • Must be a male or female between the ages of 18 and 60 years.
  • Must have a confirmed positive test for HIV-1, which is a type of virus that affects the immune system.
  • Must have started antiretroviral therapy (ART) during the early stage of HIV infection. ART is a treatment that helps control the virus.
  • Must have a plasma HIV-RNA level of less than 50 copies/ml for at least 24 months. This means the amount of virus in the blood is very low.
  • Must have a CD4+ T cell count greater than 350 cells/mm3 at the last routine check-up. CD4+ T cells are a type of white blood cell important for the immune system.
  • Must not have any new AIDS-defining diagnosis or worsening of HIV-related illness. This means no new serious health problems related to HIV.
  • Must be able to stick to an effective ART treatment plan for the entire study period.
  • Must be willing and able to provide written consent to participate in the study. This means agreeing to join the study after understanding what it involves.

Who cannot join the trial?

4 criteria

  • Individuals who are not **HIV-1 positive**. This means people who do not have the human immunodeficiency virus type 1.
  • Individuals who have not been treated with **effective antiretroviral therapy** during the acute phase of HIV-1 infection. Antiretroviral therapy is a treatment that helps control the virus in the body.
  • Individuals who are not within the specified age range for the study. The age range is not specified here, but it is important for eligibility.
  • Individuals who belong to a vulnerable population. This means people who might need special protection or care, such as children or those with certain disabilities.
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Investigated drugs

Antiretroviral Therapy (ART) is a treatment used to manage HIV infection. It involves taking a combination of HIV medicines every day. ART helps reduce the viral load in the body, maintain immune function, and prevent the progression to AIDS. In this study, patients who have been on ART will undergo a therapy interruption to observe how their bodies control the virus without medication.

What is already known about the treatment

Antiretroviral Therapy (ART) – This medication is administered orally and is used in the treatment of HIV-1 infection. It is well-established in medical literature as a standard treatment for managing HIV-1, particularly effective when initiated during the acute phase of infection. The main therapeutic indication is to control the viral load in HIV-1 positive individuals, preventing the progression to AIDS. At the molecular level, ART works by inhibiting the replication of the virus, targeting specific enzymes necessary for the virus to multiply. It is classified pharmacologically as an antiretroviral agent.

Investigated diseases

HIV-1 Infection – HIV-1 is a virus that attacks the immune system, specifically targeting CD4 T-cells, which are crucial for immune defense. During the acute phase of infection, individuals may experience flu-like symptoms as the virus rapidly replicates. If untreated, the virus continues to damage the immune system, leading to a decrease in CD4 T-cell count. Effective antiretroviral therapy can suppress the virus, allowing the immune system to recover and maintain a stable CD4 T-cell count. The goal of treatment is to control the viral load to undetectable levels, preventing further immune damage. Regular monitoring of CD4 T-cell counts and viral load is essential to assess the effectiveness of the therapy.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515419-24-00Estimated enrolment100 patientsSponsorOspedale San Raffaele S.r.l.

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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).