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)
Safety and tolerance of dasatinib with and without antiretroviral therapy, measured by number of AEs and SAEs — 52 weeks Measured by number of AEs and SAEs
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.
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