Study on Long-Acting Cabotegravir and Lenacapavir for HIV Patients: Evaluating Dual Antiretroviral Therapy

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hopital Necker Enfants Malades	Paris	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Hôpital Archet 2	Nice	France

Other Sites

Site Name	City	Country
Hopital Saint Antoine	Paris	France
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Centre Hospitalier De Tourcoing	Tourcoing	France
Pellegrin Hospital	Bordeaux	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
IHFB Cognacq Jay	Levallois-Perret	France
Hfvtoze Bwdbxj Czsrhfqffvtpep Aomif	Paris	France
Rlrwcmglooncgjbq Hsramrwe	Garches	France
Crqijh Hkwpchnfixt Uyqzdznxxoqvp Dm Dasee	Dijon	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	04.10.2024

Trial locations

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.

Investigated diseases:

HIV infection

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 ID:

2024-516028-33-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Long-Acting Cabotegravir and Lenacapavir for HIV Patients: Evaluating Dual Antiretroviral Therapy

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