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

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eva Bonfill
• Treatments: Dasatinib

Criteria

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:

• HBV positive serology (any marker except HBsAb after vaccination) or HCV positive RNA.

• 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.)

• Resistance to integrase inhibitors (raltegravir, dolutegravir, bictegravir) or analogues