Clinical Trial To Evaluate The Safety And Efficacy Of Dasatinib To Reduce HIV-1 Reservoir, Chronic Inflammation, And Immune Senescence In People With HIV On Long-Term Antiretroviral Treatment.

Trial details

Who runs it

Instituto De Salud Carlos III

Trial code

EU 2025-524363-20-01

Record updated

2026. június 8.

Original description

To evaluate changes in CD4, CD8 and CD56+ cell counts and activation/exhaustion markers during treatment with dasatinib.Read full original descriptionShow less

Phase II, Single-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial To Evaluate The Safety And Efficacy Of Dasatinib To Reduce HIV-1 Reservoir, Chronic Inflammation, And Immune Senescence In People With HIV On Long-Term Antiretroviral Treatment.

To evaluate changes in CD4, CD8 and CD56+ cell counts and activation/exhaustion markers during treatment with dasatinib.

Inclusion: The participant is ≥ 18 years old and informed and able to understand the full nature and purpose of the study, including possible risks and side effects, and is given ample time and opportunity to read and understand this information. Subject has the ability and agrees to cooperate with the Investigator and must sign and date the written informed consent prior to performing any of the screening procedures; Confirmed HIV-1 infection; On suppressive ART for between 1 and 10 years, defined as sustained plasma HIV-1 RNA levels below the limit of detection for at least the last 6 months. Isolated, non-consecutive viral blips <200 copies/mL are allowed if they represent less than 20% of all viral load determinations during this period; Participants must present at screening a CD4 count >500 cells/mm3 and/or CD4/CD8=1.0±0.2; Stable ART regimen for at least six months prior to the screening visit and during the screening period; Participants must commit to consistent adherence to ART and to comply with the study treatment regimen throughout the 24-week treatment period; Subject and their partner of childbearing potential must agree to use a highly effective method of contraception throughout the study as specified in Section 7. A man is of childbearing potential if, in the opinion of the Investigator, he is sexually active. Menopausal females must have experienced their last period more than 1 year prior to the date of informed consent to be classified as not of childbearing potential (a postmenopausal state is defined as cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause).

Exclusion: Participant is currently enrolled or has enrolled in a clinical trial three months prior to inclusion in the current study; Patients in current treatment with drugs that interfere with dasatinib metabolized mainly by CYP3A4 and those that induce CYP3A4. A list of prohibited medications can be found in section 7.5; Any other condition that, in the opinion if the Investigator, may interfere with the efficacy and/or safety evaluation of the trial; Any condition or situation precluding or interfering with the compliance with the protocol; History of clinically significant ventricular arrhythmias such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes; History of clinically significant pleural effusion; History of clinically significant bleeding disorder including congenital bleeding disorders, acquired bleeding disorder within the first year of life and ongoing or recent (≤ 3 months) clinically significant gastrointestinal bleeding; Participants are not willing or able to comply with either: all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, or other study procedures; Intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, pleural or pericardial effusion, pulmonary edema, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, QT Prolongation (QTcF >450 msec for males or >470 msec for females) or use of QT-prolonging medications, or psychiatric illness/social situations that would limit compliance with study requirements; Laboratory abnormalities at screening: a. Hemoglobin < 11 g/dl b. Platelet count < 75,000/µL c. Absolute neutrophil count (ANC) <1,000 cells/µL d. ALT and/or AST > 1.5 x ULN e. Hypokalemia according to local laboratory normality values. f. Hypomagnesemia according to local laboratory normality values; Known infection with hepatitis B or hepatitis C: positive for hepatitis B surface antigen, positive for hepatitis C antibody (without treatment with Direct Action Antivirals (DAA) or spontaneous clearance); Lactose Intolerance or Malabsorption Syndrome: Patients with hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption; Pregnant or breastfeeding women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.

EU CTIS 2025-524363-20-01