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Active, Not Recruiting

NCT Number: NCT05527418

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Recent HIV-1 Infection

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Eva Bonfill

Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

dasatinib

Drug

Dasatinib monotherapy 70 mg/day, during 16 weeks.

Placebo

Drug

Placebo during 16 weeks.

Primary outcomes

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

    Time frame: 52 weeks

    Measured by number of AEs and SAEs

Secondary outcomes

  1. Antiretroviral capacity of dasatinib

    Time frame: at week 0 and 4

    Measured by quantification of plasma HIV-1 viral load during 4-week administration of dasatinib monotherapy.

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

    Time frame: at week 0, 4, 16 and 52

    Measured by changes in the viral reservoirs (integrated DNA, genetically intact virus, residual and induced viral replication and determination of integration sites)

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

    Time frame: at week 0, 4, 16 and 52

    Measured by changes in ultra-sensitive CRP, IL6, TNF alpha and CD4/CD8, CD25, CD69, CD38, HLA-DR+.

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

    Time frame: at week 0, 4, 16 and 52

    Measured by NK phenotyping and in vitro replication inhibition tests.

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

    Time frame: at week 1, 2, 3, 4, 8, 12, 16

    Measured by Cmax

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

    Time frame: at week 1, 2, 3, 4, 8, 12, 16

    Measured by Cmin

  7. Impact of dasatinib on markers of senescence

    Time frame: at week 0, 4, 16 and 52

    Measured by expression in PBLs of beta-galactosidase, Bcl-2, Histone H2A, p16 and CD87.

Sponsors and collaborators

Lead sponsor

Eva Bonfill

Other

Registry information

Acronym: DASAHIVCURE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2022
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.