Study on the Safety and Effects of Dasatinib for Reducing Inflammation in People with HIV on Antiretroviral Therapy

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What is this study about?

This clinical trial is focused on studying the effects of the medication dasatinib on people living with HIV who are already receiving antiretroviral treatment. Dasatinib, also known by its code name BMS-354825, is a drug that is being tested to see if it can help reduce inflammation and the persistence of the virus in the body. The study will compare the effects of dasatinib with a placebo, which is a substance with no active medication, to understand its impact better.

The purpose of the study is to evaluate the safety and effects of taking dasatinib at a dose of 70 mg once daily for 24 weeks. Participants will be monitored to see how their bodies respond to the medication, including any side effects they might experience. The study will also look at how dasatinib affects certain cells in the immune system, specifically CD4+ T cells, which are important in fighting infections. Researchers will measure changes in these cells at different times during the study to understand the drug’s impact.

Throughout the study, participants will have regular check-ups and blood tests to monitor their health and the levels of dasatinib in their blood. The study aims to provide valuable information on whether dasatinib can be a safe and effective addition to current HIV treatments, potentially helping to manage the disease better and improve the quality of life for those affected. The study is expected to continue until 2025, with recruitment starting in 2024.

1 joining the study

Upon joining the study, the participant will begin by confirming their eligibility. This includes being at least 18 years old, having a confirmed HIV-1 infection, and being on a stable antiretroviral therapy (ART) regimen for at least three years.

Participants must agree to adhere to their ART regimen and comply with study requirements, including attending follow-up visits.

2 initial assessment

An initial assessment will be conducted to establish baseline health metrics. This may involve blood tests and other evaluations to ensure the participant’s health status is suitable for the trial.

3 medication administration

Participants will begin taking dasatinib at a dose of 70 mg once daily. This medication is administered orally in the form of a film-coated tablet.

The duration of dasatinib administration is 24 weeks.

4 regular monitoring

Throughout the 24-week period, participants will undergo regular monitoring. This includes blood tests at specified intervals to assess the impact of dasatinib on viral persistence and inflammation.

Monitoring will occur at weeks 0, 2, 12, 24, 28, 36, and 48 to evaluate the biological effects and safety of the treatment.

5 follow-up assessments

After completing the 24-week dasatinib treatment, follow-up assessments will continue to evaluate the durability of the treatment effects.

These assessments will focus on the participant’s immune response and any changes in HIV-1 reservoir levels.

6 end of study

The study is estimated to conclude by May 2025. Participants will have a final assessment to summarize the outcomes of their participation in the trial.

Who Can Join the Study?

Must be a male or female who is at least 18 years old on the day of screening.
Must have a confirmed infection with the HIV-1 virus, which is the virus that causes AIDS.
Must have been receiving suppressive cART (combination antiretroviral therapy) for at least 3 years. This means their viral load, or the amount of virus in the blood, has been kept below 50 copies/mL, with some exceptions for small, temporary increases.
Must have been on the same ART (antiretroviral therapy) regimen for at least 4 weeks before the start of the study.
Must be willing and able to stick to their ART regimen for the entire duration of the study.
Must be willing to follow the study’s requirements and be available for follow-up visits for the planned duration of the study.
Must understand the information provided about the study and be able to give written consent to participate, as judged by the study’s main investigator.
If a female who is capable of becoming pregnant, must use an effective method of birth control, such as hormonal contraception or an intra-uterine device (IUD), starting 14 days before the first dose of the study medication and continuing until 3 months after the last dose. If not sexually active with males at the start, must agree to use birth control if they become sexually active during the study.
If a male who is sexually active with females, must be sterilized or agree to use an effective method of birth control with their female partner, such as hormonal contraception or an IUD, from the first day of the study medication until 3 months after the last dose. If not sexually active with females at the start, must agree to use birth control if they become sexually active during the study.
If female, must be willing to take urine pregnancy tests at specific times during the study.
Must be willing to have blood drawn at specific times as outlined in the study schedule.

Who Cannot Join the Study?

Individuals who are not living with human immunodeficiency virus (HIV) cannot participate. HIV is a virus that attacks the body’s immune system.
Participants must be on suppressive ART. ART stands for antiretroviral therapy, which is a treatment for HIV that helps keep the virus under control.
Participants must be able to take the medication dasatinib at 70 mg once daily. Dasatinib is a type of medication used in this study.
Participants must be within the specified age range, which includes adults.
Both male and female participants are eligible, but certain health conditions or treatments may exclude them.
Individuals who are part of a vulnerable population, such as those unable to give informed consent, are not eligible.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hoycuquz Ulzmylfrajprw Hzpfqvhc Tdyzg y Pwjrcs Ijongsft Ctxfys dimuvozvvmxmgauvd (qcsj	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	13.06.2024

Trial locations

Investigated drugs:

Dasatinib

Dasatinib is a medication being studied for its safety and effects on viral persistence and inflammation in people living with HIV who are already receiving antiretroviral treatment. The trial aims to see how well dasatinib is tolerated when taken once daily for 24 weeks. Researchers are also looking at how dasatinib affects certain biological markers related to the immune system in these patients.

Human Immunodeficiency Virus (HIV) – HIV is a virus that attacks the body’s immune system, specifically the CD4 cells, which are a type of white blood cell. 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, many people experience flu-like symptoms, but as the virus 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 can vary greatly among individuals, influenced by factors such as overall health and access to medical care.

Trial ID:

2024-513714-36-01

Protocol code:

BCN04-DASA

NCT ID:

NCT05780073

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effects of Dasatinib for Reducing Inflammation in People with HIV on Antiretroviral Therapy

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