Safety and Efficacy of Dasatinib to Reduce HIV Reservoir, Inflammation and Immune Aging in Adults with HIV on Long‑Term Antiretroviral Therapy

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What is this study about?

The study involves adults living with HIV-1 infection who are already taking long‑term antiretroviral medication. The investigational drug being tested is a tablet containing dasatinib, while a matching tablet that contains no active medicine (a placebo) is used for comparison.

The purpose of the trial is to determine whether dasatinib can lower the hidden viral reservoir, lessen chronic inflammation, and improve signs of immune senescence. Researchers will measure changes in several types of immune cells, including CD4, CD8 and CD56+ cells, as well as markers that show how active or exhausted these cells are. In simple terms, the viral reservoir refers to tiny amounts of virus that stay hidden in the body despite treatment; chronic inflammation is ongoing swelling that can damage tissues; immune senescence describes the gradual aging and reduced effectiveness of the immune system; and CD4, CD8 and CD56+ are different groups of white blood cells that help fight infections.

Participants are randomly assigned to receive either the dasatinib tablet or the placebo tablet, and neither the participants nor the study staff know which one is given (double‑blind). The medication is taken once daily for up to about a year, with brief clinic visits shortly after the first dose and then at several later time points to collect blood samples and check for any side effects or safety concerns.

1 enrollment and randomization

after joining the trial, the patient is assigned by a computer system to receive either dasatinib tablets or a placebo containing microcrystalline cellulose. the assignment is double‑blind, meaning the patient and the study staff do not know which product is given.

2 baseline assessments

before starting any medication, the patient undergoes a series of baseline evaluations. these include blood draws to measure cd4, cd8 and cd56+ cell counts, activation and exhaustion markers, and levels of inflammation markers such as il‑6, crp, tnfα and scd163. the baseline data serve as reference points for later comparisons.

3 receipt of study medication

the patient receives a supply of study medication for the first period of treatment. if assigned to the test group, the medication is dasatinib 50 mg oral tablets; if assigned to the control group, the medication is a matching tablet of microcrystalline cellulose that contains no active drug.

4 initiation of medication

the patient begins taking the study medication as instructed. the dose is one 50 mg tablet taken by mouth. the exact schedule (for example, daily) is provided in the study instructions that accompany the medication.

5 early safety monitoring (day 2‑3)

within two to three days after the first dose, the patient returns for an early safety visit. blood is drawn to assess immediate changes in cd4, cd8, cd56+ cell counts and activation markers, as well as to check for any adverse effects.

6 regular follow‑up visits

the patient attends scheduled clinic visits at weeks 4, 12, 24, 28, 36 and 48. at each visit, clinical evaluation and laboratory testing are performed. blood samples are collected to measure cell counts, activation/exhaustion markers, inflammation markers, phosphorylated samhd1, viral reservoir characteristics, and other study endpoints. the patient also reports any side effects or health changes.

7 final assessment (week 48)

at the week 48 visit, the patient undergoes the last set of evaluations. these include the same laboratory measurements as earlier visits, plus a final review of safety data and overall health status. the results are used to determine the long‑term impact of the medication.

8 study completion and medication discontinuation

after the final assessment, the patient stops taking the study medication. any remaining tablets are returned to the study site. the patient may be offered routine clinical follow‑up according to standard care, but no further study‑specific procedures are required.

Who Can Join the Study?

The participant must be at least 18 years old, be able to understand what the study involves, and sign a written informed consent before any screening begins.
The person must have a confirmed diagnosis of HIV-1 infection (the virus that can cause AIDS).
The participant must have been on a stable, suppressive ART (antiretroviral therapy) regimen for 1 to 10 years, with blood tests showing the virus is undetectable for at least the past 6 months; occasional very low “blips” of virus (<200 copies per milliliter) are allowed if they occur in less than 20% of the tests.
At the screening visit the person must have a CD4 count greater than 500 cells per millimeter‑cubed and/or a CD4/CD8 ratio close to 1.0 (within plus or minus 0.2). CD4 and CD8 are types of white blood cells that help the immune system, and the ratio compares their levels.
The current ART regimen must have been unchanged for at least six months before screening and must stay the same during the screening period.
The participant must agree to take their regular ART consistently and to follow the study medication schedule for the entire 24‑week treatment period.
Both the participant and, if applicable, their partner of childbearing potential must agree to use a highly effective method of contraception throughout the study. Childbearing potential means the ability to have children; women who have not had a period for more than one year are considered not of childbearing potential.

Who Cannot Join the Study?

Not willing or able to follow all study visits, take medication as directed, have lab tests, follow lifestyle rules, or do any other required procedures.
Pregnant or breastfeeding women (pregnancy means a woman is carrying a baby after conception until birth; breastfeeding means feeding a baby with milk from the mother).
Any other health condition that the doctor thinks could affect the safety or results of the study.
Any condition or situation that would make it hard to follow the study rules.
Currently taking part in another clinical trial, or having taken part in another trial within the past three months.
Ongoing illness such as an active infection, heart failure with symptoms, fluid around the lungs or heart (pleural or pericardial effusion), fluid in the lungs (pulmonary edema), unstable chest pain (unstable angina), irregular heart rhythm (cardiac arrhythmia), high blood pressure that is not controlled, a prolonged QT interval on an ECG (QT prolongation, which means the heart’s electrical resetting takes longer than normal; defined as QTcF > 450 ms for men or > 470 ms for women), use of medicines that lengthen the QT interval, or serious mental health or social problems that would stop you from following the study.
History of serious abnormal heart rhythms such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes (dangerous fast heart rhythms that start in the lower chambers of the heart).
History of serious fluid buildup around the lungs (pleural effusion).
History of serious bleeding problems, including inherited bleeding disorders, bleeding disorders that began in the first year of life, or recent (within three months) significant bleeding in the stomach or intestines.
Lab test results at screening that are outside normal limits:
- Hemoglobin less than 11 g/dL (low red blood cell level).
- Platelet count less than 75,000 per microliter (low blood clotting cells).
- Absolute neutrophil count (ANC) less than 1,000 cells/µL (low white blood cells that fight infection).
- ALT or AST more than 1.5 times the upper normal limit (liver enzymes that indicate liver injury).
- Low potassium (hypokalemia) according to the lab’s normal range.
- Low magnesium (hypomagnesemia) according to the lab’s normal range.
Known infection with hepatitis B or hepatitis C (positive test for hepatitis B surface antigen or hepatitis C antibody without successful treatment).
Lactose intolerance or malabsorption syndromes such as hereditary galactose intolerance, total lactase deficiency, or glucose‑galactose malabsorption (inability to digest certain sugars).
Currently taking medicines that interfere with dasatinib because they are broken down mainly by the enzyme CYP3A4 or that increase the activity of this enzyme (these drugs can change how dasatinib works).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	01.05.2026

Trial locations

Investigated drugs:

Dasatinib

dasatinib is a medication taken by mouth that belongs to a group of drugs called tyrosine kinase inhibitors. In this study, it is being tested to see if it can lower the amount of hidden HIV in the body, reduce ongoing inflammation, and improve the health of the immune system in people who are already on long‑term HIV treatment. Researchers will look at how dasatinib affects important immune cells, such as CD4, CD8, and natural killer cells, and whether it changes markers that show how active or exhausted these cells are. The goal is to find out if dasatinib can make the immune system work better and help control HIV more effectively.

HIV-1 infection – HIV-1 infection is a viral condition caused by the human immunodeficiency virus type 1. The virus enters the body and infects immune cells, especially CD4⁺ T cells. Over time the number of these cells gradually declines, reducing the immune system’s ability to fight infections. The infection often moves from an initial phase with flu‑like symptoms to a chronic phase where the virus continues to replicate. As the disease progresses, the immune response becomes increasingly weakened, leading to more frequent infections and health changes.

Trial ID:

2025-524363-20-01

Protocol code:

DASAVIR

Trial Phase:

Therapeutic exploratory (Phase II)

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Safety and Efficacy of Dasatinib to Reduce HIV Reservoir, Inflammation and Immune Aging in Adults with HIV on Long‑Term Antiretroviral Therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?