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Study on Long-Acting Cabotegravir and Lenacapavir for HIV Patients: Evaluating Dual 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 is focused on studying the treatment of HIV infection, a virus that attacks the body's immune system. The study will use a combination of two medications: cabotegravir and lenacapavir. These medications are part of a group called antiretrovirals, which help control the virus in the body. Cabotegravir is available as both a tablet and a prolonged-release injection, while lenacapavir is available as a tablet and an injection solution. The purpose of the study is to evaluate the effectiveness of these medications when used together over a period of 48 weeks.

Participants in the study will receive the medications in different forms: Sunlenca as a 300 mg film-coated tablet and a 464 mg solution for injection, and Vocabria as a 30 mg film-coated tablet and a 600 mg prolonged-release suspension for injection. The study will monitor the participants' health and the virus levels in their blood to see how well the treatment works. The study will also look at any side effects that may occur and how the participants feel about the treatment.

The study will last for about 48 weeks, during which participants will receive regular check-ups to monitor their health and the effectiveness of the treatment. The goal is to maintain control over the virus without it becoming resistant to the medications. Participants will be observed for any signs of the virus becoming active again, which is known as virological failure. The study will also assess the participants' satisfaction with the treatment and any changes in their overall health, including weight and metabolic parameters like cholesterol and blood sugar levels.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    Blood tests are performed to ensure stable health conditions, such as liver function and kidney function, and to confirm an undetectable viral load.

  2. Step 2

    Medication initiation

    The study involves the administration of two medications: lenacapavir and cabotegravir.

    Initially, Sunlenca 300 mg film-coated tablets (lenacapavir) are taken orally. The dosage and frequency are determined by the study protocol.

    Concurrently, Vocabria 30 mg film-coated tablets (cabotegravir) are also taken orally as per the prescribed schedule.

  3. Step 3

    Transition to injection

    After the initial oral phase, the treatment transitions to injections.

    Sunlenca 464 mg solution for injection (lenacapavir) is administered as an injection.

    Vocabria 600 mg prolonged-release suspension for injection (cabotegravir) is also administered as an injection.

    The frequency and duration of these injections are specified in the study protocol.

  4. Step 4

    Follow-up and monitoring

    Regular follow-up visits are scheduled to monitor health status and treatment efficacy.

    Blood tests are conducted to measure viral load and ensure it remains below 50 copies/mL.

    Any side effects or adverse reactions are documented and managed as necessary.

  5. Step 5

    Completion of study

    The study lasts for 48 weeks, during which the effectiveness of the dual therapy is evaluated.

    At the end of the study, a final assessment is conducted to determine the overall success of the treatment.

Who can join the trial?

14 criteria

  • You must be at least 18 years old.
  • If you are a woman who could become pregnant, you need to agree to use a reliable form of birth control during the study.
  • You should be part of a social security system.
  • You need to provide written consent, which means you agree to participate in the study after understanding all the details.
  • You must have an HIV-1 infection.
  • You should have been on a stable oral antiretroviral treatment for at least 6 months.
  • You should have been treated with multiple types of antiretroviral medications.
  • Your HIV levels should be undetectable, meaning less than 50 copies/mL in the last 6 months. A small increase between 50 and 200 copies/mL is allowed once in the last 6 months.
  • If your HIV levels are not controlled and are 200 copies/mL or more in the last 12 months, you may still be eligible if a group of doctors decides it's suitable for you.
  • Your liver enzymes, called ASAT and ALAT, should be less than 3 times the normal level.
  • Your kidney function, measured by creatinine GFR, should be more than 60 mL/min.
  • Your hemoglobin, which is a part of your blood, should be more than 10 g/dL.
  • Your platelets, which help with blood clotting, should be more than 100,000 per mm3.
  • You need to agree to use protection during sexual intercourse for the duration of the trial.

Who cannot join the trial?

4 criteria

  • Individuals who do not have an HIV infection cannot participate. HIV infection is a condition caused by the human immunodeficiency virus, which affects the immune system.
  • Participants must be within a specific age range, which is not specified here, but typically means they must be adults.
  • Both male and female participants are eligible, so gender is not a reason for exclusion.
  • Participants who are part of a vulnerable population are not excluded. A vulnerable population refers to groups who may have limited ability to protect their interests, such as children or those with certain disabilities.
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Investigated drugs

  • Cabotegravir

    is a medication used in this trial as part of a dual antiretroviral therapy. It is designed to help control HIV infection by preventing the virus from multiplying in the body. This medication is administered as a long-acting injection, which means it is given less frequently than daily pills, potentially improving convenience and adherence to the treatment.

  • Lenacapavir

    is another medication used in combination with cabotegravir in this trial. It also works to control HIV infection by targeting a different part of the virus's life cycle. Like cabotegravir, lenacapavir is administered as a long-acting injection, which can help maintain consistent levels of the medication in the body and reduce the frequency of dosing.

What is already known about the treatment

  • Cabotegravir

    This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating HIV infection. It is part of a dual long-acting antiretroviral therapy, often combined with lenacapavir. Cabotegravir works by inhibiting the integrase enzyme, which is essential for the HIV virus to replicate within human cells. It is classified as an integrase strand transfer inhibitor (INSTI), and its use is being evaluated for maintaining viral suppression in individuals with HIV.

  • Lenacapavir

    This medication is also administered as an injection and is under investigation in clinical trials for its role in treating HIV infection. It is used in combination with cabotegravir as part of a dual long-acting antiretroviral therapy. Lenacapavir functions by targeting the HIV capsid, disrupting the virus's ability to replicate and assemble. It belongs to a novel class of antiretroviral agents, and its effectiveness in maintaining viral suppression is being assessed in ongoing studies.

Investigated diseases

HIV infection – HIV infection is 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 acquired immunodeficiency syndrome (AIDS), where the immune system is severely damaged. The progression of the disease varies among individuals, and some may remain asymptomatic for years.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516028-33-01Estimated enrolment30 patientsSponsorInst Medecine Epidemiologie Appliquee

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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).