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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEva Bonfill

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Dasatinib
  • Placebo

Treatment groups

24 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Eva Bonfill

Lead sponsor

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Sponsor institution