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 study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Hospital Clinico San Carlos	Madrid	Spain
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal

Other Sites

Site Name	City	Country
National Institute For Infectious Diseases Lazzaro Spallanzani	Rome	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Hospital Universitario Infanta Leonor	Madrid	Spain
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Hospital Universitario Basurto	Bilbao	Spain
zibp Zentrum fuer Infektiologie Berlin Prenzlauer Berg GmbH	Berlin	Germany
Institute Of Tropical Medicine	Antwerp	Belgium
Praxis Ebertplatz	Cologne	Germany
Virgen del Rocío University Hospital	Sevilla	Spain
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo	Milan	Italy
Centro Hospitalar Universitario De Santo Antonio E.P.E.	Porto	Portugal
Hospital Alvaro Cunqueiro	Vigo	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
IKF Pneumologie GmbH & Co. KG	Frankfurt	Germany
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari	Bari	Italy
Dr. Scholten & Schneeweiß GbR	Cologne	Germany
Hessogss Uajklnihxpypq Du Lp Pgopzuwg	Madrid	Spain
Pmhh Tewiy Hwxouahj Uftwkhceajnf	Sabadell	Spain
Uraqkpaqadivfsihppmqz Dzmglyvemok Auf	Duesseldorf	Germany
Haycuabm Dq Lb Sghng Cuhs I Snqy Pbf	Barcelona	Spain
Acdvmoh Ojfnqqvdpqe Pseu Gmqgdpwz Xtzkg	Bergamo	Italy
Foldcgrbf Pjcw Ln Itppiauteqepp Btdjxxdea Dlp Hwnsfxak Ujrakkqgjwyps Lw Pkw	Madrid	Spain
Hnokznoj Vckf dakevxfr	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	22.12.2024
Germany	Not recruiting	22.12.2024
Italy	Not recruiting	22.12.2024
Portugal	Recruiting	22.12.2024
Spain	Not recruiting	22.12.2024

Trial locations

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.

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 ID:

2024-515070-28-00

Protocol code:

221611

NCT ID:

NCT06694805

Trial Phase:

Therapeutic confirmatory (Phase III)

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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

What is this study about?

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