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Study on the Effectiveness of Cabotegravir and Rilpivirine for People with HIV-1 Who Have Not Responded Well to Oral Treatment

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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 people living with HIV-1, a virus that affects the immune system. The study will use two medications: REKAMBYS and Vocabria. REKAMBYS contains the active substance rilpivirine, and Vocabria contains the active substance cabotegravir. Both medications are given as injections that release the medicine slowly over time.

The purpose of the study is to see if these injections can better control the virus in people who have not responded well to their current oral HIV treatments. Participants will receive injections of REKAMBYS and Vocabria every two months for a period of six months. The study will compare the effectiveness of these injections to the standard oral treatments that participants are currently taking.

Throughout the study, participants will be monitored to see how well the virus is controlled and to check for any side effects. The goal is to find out if the injectable treatment can provide better viral suppression, which means reducing the amount of virus in the blood, compared to the oral treatments. This study will help determine if the injectable treatment is a better option for people with HIV-1 who have not had success with their current medications.

The research process

The trial runs in 6 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 verifying age, weight, and documented HIV-1 infection with specific viral load levels.

    Participants must demonstrate an insufficient response to their current oral antiretroviral therapy (ART) regimen.

  2. Step 2

    Baseline evaluation

    A baseline evaluation is performed to establish the participant's health status and current viral load. This serves as a reference point for future assessments.

  3. Step 3

    Initiation of treatment

    Participants begin treatment with two injectable medications: REKAMBYS (rilpivirine) and Vocabria (cabotegravir).

    Both medications are administered as prolonged-release suspensions for injection, given intramuscularly every two months.

  4. Step 4

    Ongoing monitoring

    Regular monitoring is conducted to assess the participant's response to the treatment. This includes measuring viral load and checking for any side effects.

    Participants continue their current oral ART regimen until the viral load result at Month 6 is available.

  5. Step 5

    Evaluation at month 6

    At Month 6, a primary evaluation is conducted to determine the virologic response, specifically if the HIV-1 RNA level is below 50 copies per milliliter.

    The Snapshot Algorithm is used to assess the virologic response.

  6. Step 6

    Long-term follow-up

    Participants are monitored for secondary endpoints, including the time to virologic suppression and any development of resistance-associated mutations (RAMs).

    Follow-up continues through Months 12 and 24 to observe long-term effects and any potential resistance to the treatment.

Who can join the trial?

8 criteria

  • Must be at least 12 years old and weigh at least 35 kg.
  • Must have a documented infection with **HIV-1**, which is a type of virus, with a specific amount of the virus in the blood between 1,000 and 100,000 copies per milliliter.
  • Must show evidence of not responding well to their current oral **ART** (Antiretroviral Therapy) within the last 18 months. This can be shown by:
    • Less than a 1 log10 decrease in the amount of HIV-1 in the blood or more than 200 copies per milliliter at two different times, at least 4 weeks apart, after taking oral ART for at least 3 months in a row.
    • A documented period of at least 30 days in a row without taking their current oral ART, which is expected to lead to an increase in the virus in the blood.
    • A documented need to change from their current oral ART due to reasons like safety concerns or not being able to tolerate it well.
    • Must currently be taking an oral ART regimen and be willing to continue taking it until after their viral load result is available at Month 6.
    • If the participant is 18 years or older, they or their parent/legal guardian must be able to give signed informed consent. If the participant is an adolescent, they must be able to agree to participate in the study.
    • Staff members participating in the study are eligible if they are involved in supporting adherence to the treatment, can agree to participate in interviews and complete questionnaires, and have the ability to do so for up to 60 minutes.

Who cannot join the trial?

6 criteria

  • Individuals who are not living with HIV cannot participate. HIV is a virus that affects the immune system.
  • Participants must be adults, as the study is not open to children or teenagers.
  • People who are not currently experiencing viremia are excluded. Viremia means having a detectable amount of the virus in the blood.
  • Individuals who are not already receiving treatment for HIV are not eligible. The study is for those who have experience with treatment.
  • Participants must be able to receive injections every two months, as the study involves this form of medication.
  • People who are unable to follow the study procedures or attend regular visits are not eligible.
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Investigated drugs

  • CAB LA

    is an injectable medication used in the treatment of HIV-1. It is designed to be administered every two months and works by helping to suppress the virus in the body, reducing the viral load in people living with HIV.

  • RPV LA

    is another injectable medication used alongside CAB LA for treating HIV-1. Like CAB LA, it is given every two months and helps in controlling the virus, contributing to the overall goal of achieving viral suppression in individuals with HIV.

What is already known about the treatment

CAB LA + RPV LA – This medication is administered as an injectable form, given every two months. It is currently being studied in clinical trials for its effectiveness in treating HIV infections, specifically in individuals who have experienced treatment and have viremia. The main therapeutic indication is to achieve superior viral suppression compared to standard oral antiretroviral therapy. At the molecular level, CAB LA (Cabotegravir Long-Acting) works by inhibiting the integrase enzyme, preventing the integration of viral DNA into the host cell genome, while RPV LA (Rilpivirine Long-Acting) blocks the reverse transcriptase enzyme, stopping the conversion of viral RNA into DNA. This combination falls under the pharmacological classification of antiretroviral agents.

Investigated diseases

HIV Infections – HIV infections are caused by the human immunodeficiency virus, which attacks the body's immune system, specifically the CD4 cells (T cells). Over time, HIV can destroy so many of these cells that the body can't fight off infections and disease. The virus is transmitted through contact with certain body fluids of an infected person, most commonly during unprotected sex or through sharing needles. In the early stages, individuals may experience flu-like symptoms, but as the infection progresses, it can lead to more severe health issues. Without treatment, HIV can advance to AIDS, the final stage of the infection, where the immune system is severely damaged. Regular monitoring and management are crucial to control the progression of the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515070-28-00Protocol code221611Estimated enrolment332 patientsSponsorViiv Healthcare UK Limited

sourced from the EU Clinical Trials Register and site verification

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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).