Study on the Effectiveness of Rilpivirine-Based Treatment for HIV Patients with Metabolic Liver Disease Using Dolutegravir, Rilpivirine, and Emtricitabine/Tenofovir Combination

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What is this study about?

This clinical trial is focused on studying the effects of a treatment regimen for people living with HIV who also have a condition known as metabolic liver disease. The treatment being tested includes a medication called Rilpivirine, which is part of a group of drugs known as antiretrovirals. These medications are used to manage HIV by keeping the virus at very low levels in the body. The study aims to see if Rilpivirine can help slow down or reduce liver damage, specifically liver fibrosis, which is a condition where the liver becomes scarred over time.

Participants in the study will be randomly assigned to receive either the Rilpivirine-based treatment or a different treatment, which may include a placebo. The study will last for about 18 months, during which time participants will take the medication in the form of film-coated tablets. The progress of the liver condition will be monitored using non-invasive tests, which means tests that do not require surgery or entering the body. These tests will help determine if there is any change in the liver’s condition over the course of the study.

The goal of this research is to evaluate the safety and effectiveness of the Rilpivirine-based treatment in managing liver health in people with HIV. By participating in this study, researchers hope to gather valuable information that could lead to better treatment options for individuals with both HIV and metabolic liver disease. The study is designed to ensure that all participants are closely monitored for any changes in their health, and the results will contribute to a better understanding of how to manage these conditions together.

1 initial visit

Upon joining the study, you will attend an initial visit where you will receive detailed information about the trial. You will be asked to sign an informed consent form, confirming your understanding and willingness to participate.

During this visit, your medical history will be reviewed, and you will undergo a physical examination. Blood tests will be conducted to confirm your eligibility based on the study criteria.

2 treatment assignment

You will be randomly assigned to one of the treatment groups. This means you will receive a specific combination of medications as part of the study.

The medications involved in the study include Juluca (50 mg/25 mg), Truvada (200 mg/245 mg), Descovy (200 mg/25 mg), Eviplera (200 mg/25 mg/245 mg), Tivicay (50 mg), Odefsey (200 mg/25 mg/25 mg), and Edurant (25 mg). All medications are taken orally as film-coated tablets.

3 medication administration

You will take the assigned medication daily as per the instructions provided. The dosage and frequency will depend on the specific medication you are assigned.

It is important to follow the medication schedule precisely to ensure the effectiveness of the treatment.

4 regular follow-up visits

You will attend regular follow-up visits throughout the study. These visits are scheduled to monitor your health and the effectiveness of the treatment.

During these visits, you will undergo various assessments, including blood tests and non-invasive tests to measure liver health.

5 18-month evaluation

At the end of the 18-month period, a comprehensive evaluation will be conducted to assess the progression or regression of liver fibrosis.

The results will be compared to the baseline measurements taken at the start of the study to determine the effectiveness of the treatment.

Who Can Join the Study?

Patients must be over 18 years old and have an HIV infection.
Must have never received antiretroviral treatment with Rilpivirine.
Must have a stable antiretroviral therapy (ART) regimen for at least the last 6 months. Changes to combination therapies are allowed if the HIV viral load remains undetectable after the change.
Must not have resistance mutations that affect the effectiveness of Rilpivirine, Dolutegravir, Tenofovir (TDF and/or TAF), or Emtricitabine.
Must have an HIV viral load of less than 50 copies/ml for at least the last 6 months. One temporary increase (blip) of less than 500 copies/ml is allowed during this period.
Must have a condition called EHMG diagnosed by ultrasound or a CAP measurement greater than 238 dB/m with an IQR less than 30 dB/m.
Must have some degree of liver fibrosis diagnosed by ET (Fibroscan®) greater than 5.2 kPa. If ET is not possible, a FIB-4 score greater than 1.3 is required.
Must be able to understand and follow the study requirements and instructions.
Must understand the long-term commitment required for the study.
Must agree to participate in the study by signing an informed consent form.

Who Cannot Join the Study?

People who do not have metabolic liver disease and are not infected with HIV cannot participate.
Individuals who are not within the specified age range for the study cannot participate.
Participants who are not part of the specified clinical trial group cannot participate.
People who are considered part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Infanta Leonor	Madrid	Spain
Hospital Universitario Infanta Sofía	San Sebastian De Los Reyes	Spain
Fwghhibvd Ppcq Ld Ixsogkevjtkag Bjppndxsd Dal Hbcuvujd Uzlnancnmvibz Lj Pdt	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	30.04.2023

Trial locations

Investigated drugs:

Rilpivirine is a medication used as part of a treatment plan for people living with HIV. It helps to control the virus in the body, which can improve the immune system and reduce the risk of developing HIV-related complications. In this clinical trial, Rilpivirine is being studied to see if it can also help slow down or reduce liver damage in patients who have metabolic liver disease, while keeping their HIV viral load undetectable. This means that the medication is being tested not only for its ability to manage HIV but also for its potential benefits in protecting the liver from further harm.

Investigated diseases:

HIV infection

Metabolic Liver Disease in HIV-Infected People – This condition involves the liver’s metabolic processes being affected in individuals who are also infected with the Human Immunodeficiency Virus (HIV). The disease can lead to changes in liver function, often resulting in the accumulation of fat in liver cells, known as steatosis. Over time, this can progress to liver fibrosis, where scar tissue forms in the liver, potentially affecting its ability to function properly. The progression of liver fibrosis can vary, with some individuals experiencing a slow progression while others may see more rapid changes. The condition is influenced by both the metabolic changes associated with HIV and the effects of antiretroviral therapy. Monitoring liver health is crucial to managing the progression of this disease.

Trial ID:

2022-503110-23-00

Protocol code:

GESIDA 12422

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Rilpivirine-Based Treatment for HIV Patients with Metabolic Liver Disease Using Dolutegravir, Rilpivirine, and Emtricitabine/Tenofovir Combination

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?