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Study of Long-Acting Cabotegravir and Rilpivirine for People Aged 60 and Over Living with HIV-1

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 in people aged 60 years and older. The study will use two medications: Cabotegravir and Rilpivirine. These medications are given as prolonged-release injections, which means they are designed to release the medicine slowly over time. The purpose of the study is to evaluate how well these medications work in maintaining low levels of the virus in the blood.

Participants in the study will switch from their current oral antiretroviral therapy (ART) to the new treatment with Cabotegravir and Rilpivirine injections. The study will last for 96 weeks, which is a little less than two years. During this time, participants will receive regular injections and have their health monitored to see how well the treatment is working and to check for any side effects.

The study aims to see if the new treatment can keep the virus at low levels in the blood, specifically looking at the number of virus copies per milliliter of blood. This is important for managing HIV-1 and ensuring that the virus does not become active again. The results will help determine if this new treatment approach is effective for older adults living with HIV-1.

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

    The initial assessment involves confirming eligibility for the trial. This includes ensuring the absence of viral resistance and confirming a stable antiretroviral regimen.

    A blood test is conducted to verify that plasma HIV-1 RNA levels are below 50 copies per milliliter.

  2. Step 2

    Medication transition

    Participants transition from their current antiretroviral regimen to the trial medications: cabotegravir and rilpivirine.

    These medications are administered as prolonged-release suspensions through intramuscular injections.

  3. Step 3

    First injection

    The first injection of REKAMBYS (rilpivirine 900 mg) and Vocabria (cabotegravir 600 mg) is administered intramuscularly.

    This step marks the beginning of the 96-week trial period.

  4. Step 4

    Regular follow-up

    Regular follow-up visits are scheduled to monitor health and the effectiveness of the treatment.

    Blood tests are conducted periodically to ensure plasma HIV-1 RNA levels remain below 50 copies per milliliter.

  5. Step 5

    Monthly injections

    Monthly injections of cabotegravir and rilpivirine are administered to maintain medication levels in the body.

    These injections continue for the duration of the 96-week trial.

  6. Step 6

    Final assessment

    At the end of the 96-week period, a final assessment is conducted.

    This includes a comprehensive evaluation of health status and the effectiveness of the treatment regimen.

Who can join the trial?

8 criteria

  • Be able to understand and follow the study's rules and instructions.
  • Understand the long-term commitment required for the study and be likely to complete it as planned.
  • Be suitable for participating in a clinical trial with oral and injectable medications. This means no active substance use disorder, no serious organ disease, and no planned long-term work assignments outside the country.
  • Must be on a stable antiretroviral treatment without any current or past signs of the virus becoming resistant to the medication, and no previous failure with certain types of HIV medications called NNRTI and INI.
  • Have a very low level of HIV in the blood, specifically less than 50 copies per milliliter, at the time of screening.
  • If female, must not be pregnant, confirmed by a negative pregnancy test, and must not be breastfeeding.
  • Be an adult aged 60 years or older, currently receiving antiretroviral treatment for at least 6 months.
  • Must have given written informed consent, which means agreeing to participate in the study after being fully informed about it.

Who cannot join the trial?

4 criteria

  • Individuals who are not on stable oral ART (antiretroviral therapy) cannot participate. ART is a treatment for HIV that helps control the virus in the body.
  • Participants with plasma HIV-1 RNA levels of 50 copies/mL or more at the start of the study are excluded. Plasma HIV-1 RNA is a measure of the amount of HIV in the blood.
  • People under the age of 60 are not eligible to join the study.
  • Individuals who are part of a vulnerable population are not allowed to participate. A vulnerable population includes groups of people who may be at a higher risk of harm or exploitation.
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Investigated drugs

  • Cabotegravir

    is a long-acting medication used in the treatment of HIV-1. It is designed to be administered as an injection, allowing for less frequent dosing compared to daily oral medications. This can help improve adherence to treatment and maintain viral suppression in people living with HIV.

  • Rilpivirine

    is another long-acting medication used alongside Cabotegravir for the treatment of HIV-1. Like Cabotegravir, it is given as an injection, which helps reduce the frequency of dosing. Rilpivirine works by preventing the virus from multiplying, thereby helping to control the infection and improve the patient's health.

What is already known about the treatment

  • Cabotegravir

    This medication is administered as a long-acting injection, typically given once every month. It is currently being studied in clinical trials for its effectiveness in treating HIV-1, particularly in individuals aged 60 and older. Cabotegravir works by inhibiting the integrase enzyme, which is essential for the HIV virus to replicate within the body. It is classified as an integrase strand transfer inhibitor (INSTI), a type of antiretroviral medication.

  • Rilpivirine

    This medication is also administered as a long-acting injection, often in combination with Cabotegravir. It is under investigation for its use in managing HIV-1 in older adults. Rilpivirine functions by blocking the reverse transcriptase enzyme, preventing the virus from multiplying. It belongs to the class of non-nucleoside reverse transcriptase inhibitors (NNRTIs), which are used to control HIV infection.

Investigated diseases

HIV-1 – Human Immunodeficiency Virus type 1 is a virus that attacks the immune system, specifically targeting CD4 cells, which are crucial for immune defense. Over time, HIV-1 can weaken the immune system, making the body more susceptible to infections and certain diseases. The virus is primarily transmitted through contact with infected bodily fluids, such as blood, semen, vaginal fluids, and breast milk. Initially, individuals may experience flu-like symptoms, but as the virus progresses, it can lead to more severe immune system damage. Without intervention, HIV-1 can progress to Acquired Immunodeficiency Syndrome (AIDS), where the immune system is severely compromised. The progression of the disease varies among individuals, influenced by factors such as viral load and overall health.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502882-53-00Protocol codeIMIB-LOVER60-2022-03Estimated enrolment120 patientsSponsorFundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

sourced from the EU Clinical Trials Register and site verification

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