Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Long-Acting Cabotegravir and Rilpivirine for HIV Patients in Spain: Evaluating Out-of-Hospital Treatment Options

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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, a virus that attacks the body's immune system. The study involves two medications: cabotegravir and rilpivirine. These medications are being tested in two forms: as film-coated tablets and as prolonged-release injections. The purpose of the study is to evaluate how acceptable, safe, and satisfactory these treatments are for patients when administered outside of a hospital setting.

Participants in the study will receive either the combination of cabotegravir and rilpivirine as injections or as tablets. The study will last for up to 12 months, during which the participants' experiences with the treatment will be monitored. The study aims to compare the experiences of those receiving injections outside the hospital with those receiving them in a hospital. It will also assess the safety and tolerability of the treatment, which means checking for any side effects or reactions to the medication.

Throughout the study, participants will be asked to provide feedback on their satisfaction with the treatment and how convenient they find the administration method. This feedback will help determine if the out-of-hospital administration of these medications is a viable option for treating HIV. The study will also look at how often participants miss their treatment appointments and whether they need to switch to oral medication during the study period. The goal is to find the best way to provide these treatments to patients while ensuring their safety and satisfaction.

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 visit

    Upon joining the study, the patient will attend an initial visit. During this visit, the patient will receive detailed information about the study, including the schedule of visits and procedures.

    The patient will be asked to sign an informed consent form, confirming their understanding and willingness to participate in the study.

  2. Step 2

    Oral medication phase

    The patient will begin taking EDURANT 25 mg film-coated tablets and Vocabria 30 mg film-coated tablets orally. These medications are to be taken once daily for a period specified by the study protocol.

  3. Step 3

    Transition to injection phase

    After the oral medication phase, the patient will transition to receiving injections. The patient will receive REKAMBYS 900 mg prolonged-release suspension for injection and Vocabria 600 mg prolonged-release suspension for injection.

    These injections will be administered intramuscularly, meaning they are given directly into a muscle.

  4. Step 4

    Regular follow-up visits

    The patient will attend regular follow-up visits as scheduled by the study. These visits are important for monitoring the patient's health and the effects of the medication.

    During these visits, the patient may be asked to complete questionnaires to assess their experience and satisfaction with the treatment.

  5. Step 5

    Completion of study

    At the end of the study period, the patient will have a final visit. This visit will include a comprehensive assessment of the patient's health and a discussion of the study's outcomes.

    The patient will be informed about any further steps or follow-up that may be necessary after the study concludes.

Who can join the trial?

8 criteria

  • Patients must be 18 years or older.
  • Must have a chronic HIV infection.
  • HIV patients for whom LA CAB+RPV is prescribed. LA CAB+RPV refers to long-acting medications used to treat HIV.
  • Must have been on a recommended triple or dual therapy for at least 12 months, including CAB+RPV LA. This means taking a combination of medications to manage HIV.
  • Must have virological suppression for at least 6 months. This means having two consecutive tests showing an undetectable viral load (HIV-1 RNA levels in the blood are less than 50 copies/ml) for at least 6 months before joining the study.
  • Post-menopausal or fertile females must agree to avoid pregnancy during the study. If sexually active, they must use an effective method of contraception (like hormonal birth control, an intra-uterine device (IUD), or permanent sterilization in themselves or their partner) from 14 days before the first medication dose until at least 13 months after the last dose. All female participants must agree to take urine pregnancy tests at specified times during the study.
  • Must agree to participate in the study and sign the informed consent. This means understanding the study details and agreeing to take part.
  • Must have access to a center outside of a hospital where they can receive treatment without any issues.

Who cannot join the trial?

6 criteria

  • Patients who are not infected with HIV cannot participate. HIV is a virus that affects the immune system.
  • Patients who are under 18 years old cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have a history of allergic reactions to the study medications cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients with any other medical condition that the study doctors think might make it unsafe for them to participate cannot join the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Cabotegravir

    is a medication used in the treatment of HIV. It is part of a class of drugs known as integrase inhibitors, which work by blocking a specific enzyme that the HIV virus needs to multiply. This helps to lower the amount of virus in the body and can improve the immune system's function. In this trial, cabotegravir is used in a long-acting form, which means it is designed to stay in the body and work over a longer period, reducing the frequency of doses needed.

  • Rilpivirine

    is another medication used to treat HIV. It belongs to a group of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Rilpivirine works by blocking a different enzyme that the HIV virus uses to replicate. This helps to control the infection and improve the immune system. In this study, rilpivirine is also used in a long-acting form, allowing for less frequent dosing, which can be more convenient for patients.

What is already known about the treatment

Cabotegravir + Rilpivirine – This medication is administered as a long-acting injection, which can be given either in a hospital or outside of it, depending on the patient's preference and the study's findings. It is currently being studied for its effectiveness and patient satisfaction in treating HIV-infected individuals, with a focus on how well patients tolerate and accept the treatment over time. The main therapeutic use of this combination is to manage HIV infection. At the molecular level, cabotegravir works by inhibiting an enzyme called integrase, which is essential for the HIV virus to multiply, while rilpivirine blocks another enzyme called reverse transcriptase, preventing the virus from making copies of itself. This combination falls under the pharmacological classification of antiretroviral agents, specifically integrase strand transfer inhibitors (INSTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs).

Investigated diseases

Human Immunodeficiency Virus (HIV) Infection – HIV infection is a chronic viral condition that targets the immune system, specifically the CD4 cells, which are crucial for immune defense. The virus progressively weakens the immune system, making the body more susceptible to infections and certain cancers. Initially, individuals may experience flu-like symptoms, but as the virus continues to replicate, it can lead to a prolonged asymptomatic phase. Over time, if untreated, the immune system becomes severely compromised, leading to Acquired Immunodeficiency Syndrome (AIDS). The progression of the disease varies among individuals, influenced by factors such as viral load and immune response. HIV is primarily transmitted through contact with infected bodily fluids, such as blood, semen, and vaginal fluids.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503963-41-00Protocol codeOut-of-hospitalEstimated enrolment110 patientsSponsorFundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La Ciencia

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

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).