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

Eva Bonfill

Status and phase: Enrolling; Phase 2

Conditions: Recent HIV-1 Infection

Treatments: Drug: Placebo; Drug: Dasatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT05527418

2021-001288-26

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Dasatinib

Experimental group

Description:

Dasatinib monotherapy (70 mg/day) will be given for 4 weeks. Antiretroviral therapy (ART) based on unboosted integrase inhibitors will be initiated at week 4 (S4) and dasatinib will be continued with ART until week 12.

Treatment:

Drug: Dasatinib

Placebo

Placebo Comparator group

Description:

Placebo monotherapy will be given for 4 weeks. Antiretroviral therapy (ART) based on unboosted integrase inhibitors will be initiated at week 4 (S4) and placebo will be continued with ART until week 12.

Treatment:

Drug: Placebo