Overview
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
Inclusion Criteria:
- 18 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 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.)