RecruitingPhase 2NCT05527418
Safety, Tolerance and Antiretroviral Activity of Dasatinib: a Pilot Clinical Trial in Patients With Recent HIV-1 Infection
Sponsor
Eva Bonfill
Enrollment
24 participants
Start Date
Jan 26, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria5
- to 65 years.
- Documented asymptomatic HIV-1 infection of 3-12 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 Criteria9
- 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.)
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Interventions
DRUGDasatinib
Dasatinib monotherapy 70 mg/day, during 16 weeks.
DRUGPlacebo
Placebo during 16 weeks.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05527418