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

NCT05527418 | Recruiting Phase 2 DMC

• 1 other identifier: 2021-001288-26
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recent HIV-1 Infection

Outcome Measures

Primary Outcomes (1)

• Safety and tolerance of dasatinib with and without antiretroviral therapy, measured by number of AEs and SAEs

  Measured by number of AEs and SAEs

  52 weeks

Secondary Outcomes (7)

• Antiretroviral capacity of dasatinib

  at week 0 and 4

• Changes in the viral reservoirs of patients with recent HIV-1 infection induced by dasatinib administration.

  at week 0, 4, 16 and 52

• Changes in markers of inflammation and immune activation induced by dasatinib administration.

  at week 0, 4, 16 and 52

• Changes in SAMHD1 phosphorylation levels and cytotoxic activity against HIV-1 induced by dasatinib.

  at week 0, 4, 16 and 52

• Pharmacokinetic interactions of coadministration non-boosted integrase inhibitor-based antiretroviral therapy with dasatinib.

  at week 1, 2, 3, 4, 8, 12, 16

Study Arms (2)

Dasatinib

EXPERIMENTAL

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.

Drug: Dasatinib

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Dasatinib DRUG

Dasatinib monotherapy 70 mg/day, during 16 weeks.

Dasatinib

Placebo DRUG

Placebo during 16 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Eva Bonfill: lead

Study Sites (1)

Eva Bonfill

Barcelona, Spain

RECRUITING

MeSH Terms

Interventions

Dasatinib

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Central Study Contacts

Eva Bonfill

CONTACT

+34 932275400; bonfill@recerca.clinic.cat

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Manager

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: September 2, 2022
• Study Start: January 26, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

ES (1)