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Clinical Trials in Spain / NCT05527418
Active, not recruiting Phase 2

Safety, Tolerance and Antiretroviral Activity of Dasatinib: a Pilot Clinical Trial in Patients With Recent HIV-1 Infection

NCT05527418 · tracked via the Priya Life Science Spain tracker
Sponsor
Eva Bonfill
Phase
Phase 2
Started
2024-01-26
Last updated
2026-07-06

Condition(s) studied

Recent HIV-1 Infection

Investigational drug(s) / intervention(s)

Dasatinib →Placebo

Dasatinib: Dasatinib monotherapy 70 mg/day, during 16 weeks.

Placebo: Placebo during 16 weeks.

Study summary

Study to evaluate the safety, tolerability and antiretroviral activity of a new therapeutic strategy, based on the administration of dasatinib, an ITK, in patients with recent (3-12 months) asymptomatic HIV-1 infection.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * 18 to 65 years. * Documented asymptomatic HIV-1 infection of more than 3 months' duration (all patients must have a positive Western blot, including the p31 band whose appearance indicates infection of more than 90 days duration). * Not having received ART * CD4 T-lymphocyte count\> 350 / μl * Patient giving written informed consent Exclusion Criteria: * Active HBV (HBsAg+ or DNA+) and/or HCV (RNA+) infection in screening. * ALT\> 2 UNL, glomerular filtration rate \<70 mL / 1.73 m2, leukocytes \<4000 / mm3, total lymphocyte count \<1000 / mm3, platelets \<100,000 / mm3 or Hg \<12g / dL. * Pregnancy or active breastfeeding * Ongoing or previous pleural effusion * Chronic obstructive pulmonary disease, bronchial asthma or recent chest trauma. * History of gastrointestinal or other bleeding. * Any concomitant treatment with potentially dangerous drug interaction with dasatinib. * Any clinical condition, at the opinion of the investigator, contraindicating participation (for example, * Active neoplastic disease, active concomitant infection, etc.)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Eva Bonfill Barcelona Spain

On this site

📄 Sprycel (dasatinib) drug profile →

More Eva Bonfill trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05527418 on ClinicalTrials.gov ↗ ← All trials in Spain