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Study on the Safety and Effects of Dasatinib in Patients with Recent HIV-1 Infection

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What is this study about?

This clinical trial is focused on studying the safety and tolerance of a medication called dasatinib in patients who have recently been infected with HIV-1 but do not show any symptoms. Dasatinib is a type of medication known as a protein kinase inhibitor, which means it works by blocking certain proteins that help the virus grow. The study will compare the effects of dasatinib with a placebo, which is a substance that looks like the medication but does not contain any active ingredients.

The purpose of the study is to evaluate how safe and tolerable dasatinib is for people with recent HIV-1 infection. Participants will take the medication for a period of time, and researchers will monitor them to see how their bodies respond. The study will also look at how the medication affects the immune system and the levels of the virus in the body. This includes checking the number of certain immune cells and markers of inflammation, as well as measuring the amount of virus present before starting any other antiretroviral therapy.

Throughout the study, participants will be closely observed to ensure their safety and to gather information on how dasatinib impacts the virus and the immune system. The study aims to provide valuable insights into whether dasatinib can be a safe and effective treatment option for people with recent HIV-1 infection. The trial is expected to continue until 2026, allowing researchers to collect comprehensive data over time.

1 joining the study

Upon joining the study, the patient will provide written informed consent, confirming understanding and agreement to participate.

Eligibility is confirmed based on age (18 to 65 years), documented asymptomatic HIV-1 infection for more than 3 months, and a CD4 T lymphocyte count greater than 350 per microliter.

2 initial assessment

An initial assessment will be conducted to evaluate the patient’s health status and confirm eligibility criteria.

This includes a review of medical history and a physical examination.

3 medication administration

The patient will begin taking the medication dasatinib orally. The specific dosage and frequency will be provided by the study team.

The duration of this phase is 4 weeks, during which the patient will take dasatinib as a monotherapy, meaning it is the only medication being taken for the study.

4 monitoring and follow-up

Regular monitoring will occur to assess the safety and tolerability of dasatinib. This includes checking for any side effects or adverse reactions.

The study team will conduct various tests to evaluate immune recovery, inflammatory markers, and other health indicators.

5 completion of study

Upon completion of the study period, a final assessment will be conducted to evaluate the overall health and response to the medication.

The patient will receive information about the study’s findings and any further steps if necessary.

Who Can Join the Study?

  • Age range: 18 to 65 years.
  • Documented asymptomatic HIV-1 infection of more than 3 months duration. This means you have tested positive for HIV-1 but do not show symptoms, and the infection has been present for more than 90 days.
  • Not having received ART (antiretroviral therapy), which is the treatment for HIV.
  • CD4 T lymphocyte count greater than 350 cells per microliter. CD4 T lymphocytes are a type of white blood cell important for your immune system.
  • Patient giving written informed consent, meaning you agree to participate in the study after being fully informed about it.

Who Cannot Join the Study?

  • Patients who have symptoms of HIV-1 infection cannot participate.
  • Patients who have been infected with HIV-1 for less than 3 months cannot participate.
  • Patients who are currently taking other medications that might interfere with the study drug cannot participate.
  • Patients with a history of severe allergic reactions to similar medications cannot participate.
  • Patients with significant heart problems cannot participate.
  • Patients with uncontrolled high blood pressure cannot participate.
  • Patients with active infections other than HIV-1 cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are participating in another clinical trial cannot participate.
  • Patients with a history of cancer within the last 5 years 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 Status
Hospital Clinic De Barcelona Barcelona Spain
Brv Cyzjlupcuh Barcelona Spain
Cka Dncnmafbv Barcelona Spain
Fnlzctrix Ptvd Lg Ibkdurbnqeqma Bynuxdzvm Djo Hskvlzdw Urevqfrtxvulg Lz Pdf Madrid Spain
Hpgizcwe Uenodoyhyzimb Hzdyuziq Totxl y Pztlsc Ihhdgyge Cqprie dcemmvvzblkesjxzh (uotp Badalona Spain
Hepiontu Vgjj dwscenyk Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
17.11.2022

Trial locations

Investigated drugs:

Dasatinib is a medication being tested in this clinical trial. It is known as a type of ITK, which stands for immunomodulatory tyrosine kinase inhibitor. This medication is being studied to see if it is safe and well-tolerated by people who have recently been infected with HIV-1 but do not yet show symptoms. The goal is to understand how dasatinib might help in managing the virus in these patients. By participating in this trial, researchers hope to learn more about how dasatinib can be used as part of a new treatment strategy for HIV-1 infection.

Investigated diseases:

Human Immunodeficiency Virus Type 1 (HIV-1) Infection – HIV-1 infection is a viral disease caused by the human immunodeficiency virus type 1, which primarily attacks the immune system. In the early stages, individuals may not show symptoms, which is referred to as the asymptomatic phase. During this phase, the virus replicates in the body and gradually weakens the immune system by targeting CD4 cells, a type of white blood cell. As the infection progresses, the immune system becomes increasingly compromised, making the body more susceptible to other infections and diseases. Over time, if untreated, the infection can lead to acquired immunodeficiency syndrome (AIDS), where the immune system is severely damaged.

Trial ID:
2024-519641-30-00
Protocol code:
DASAHIVCURE
NCT ID:
NCT05527418
Trial Phase:
Therapeutic exploratory (Phase II)

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