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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital Costa del Sol	Marbella	Spain
Cbigdk ds Sdydd Lkthiajvo	Marbella	Spain
Cuazkq dx Sgxhs Sfv Lrvb ds Shrzcorlfo	San Luis de Sabinillas	Spain
Ckdydz di Skuut Ibpzcwucvdwwc i Mnbotplqy Tpltuowelvdwzo Drwibughi &vogzzs Vsdg dyjsceqhthiajte	Barcelona	Spain
Buo Cqjujbstrj	Barcelona	Spain
Cae Deukcw Rephqb	Badalona	Spain
Hqcantyp Uueldxnuvjahc Hokgkbmc Tyekl y Pqvhvj Iojztltx Cgxkqg dtfcvysnowczajdvg (qzrx	Badalona	Spain
Hegxntbh Vxoc dzqrosme	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.09.2023

Trial locations

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.

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 ID:

2023-503963-41-00

Protocol code:

Out-of-hospital

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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