Tenofovir Abacavir Platelet Activation Study

Overview

Some but not all observational studies have found that current exposure to abacavir is associated with increased risk of cardiovascular events such as myocardial infarction, stroke and cardiovascular death. This study aim to investigate possible adverse effect of abacavir on platelet reactivity, coagulation and endothelial activation in HIV-1 infected patients. The study is an open-labeled cross-over trial, where patients receiving antiretroviral therapy containing abacavir switch treatment to a regimen containing tenofovir and vice versa for a period of 90 days.

Full Title of Study: “Changes in Coagulation and Platelet Reactivity in HIV-1 Infected Patients Switching Between Abacavir and Tenofovir Containing Antiretroviral Regimens”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2016

Interventions

  • Drug: abacavir (600 mg QD)
  • Drug: tenofovir (245 mg QD)

Arms, Groups and Cohorts

  • Experimental: Tenofovir to abacavir
    • Patients switching from tenofovir (245 mg QD) to abacavir (600 mg QD)
  • Experimental: Abacavir to tenofovir
    • Patients switching from abacavir (600 mg QD) to tenofovir (245 mg QD)

Clinical Trial Outcome Measures

Primary Measures

  • Differences in platelet aggregation (Multiplate) before and after switching between abacavir and tenofovir.
    • Time Frame: before and after 90 days intervention
  • Differences in clot formation kinetics (thromboelastography) before and after switching between abacavir and tenofovir.
    • Time Frame: before and after 90 days intervention

Secondary Measures

  • Concentration of plasma lipids
    • Time Frame: Before and after 90 days intervention
  • activated partial thromboplastin time (APTT)
    • Time Frame: 90 days
  • international normalized ratio (INR)/Factor II, VII, X
    • Time Frame: Before and after 90 days intervention
  • Platelet count
    • Time Frame: Before and after 90 days intervention
  • Fibrinogen
    • Time Frame: Before and after 90 days intervention
  • D-dimer
    • Time Frame: Before and after 90 days intervention
  • Antithrombine
    • Time Frame: Before and after 90 days intervention
  • Interleukin 6 (IL-6)
    • Time Frame: Before and after 90 days intervention
  • High sensitivity C reactive protein (HS-CRP)
    • Time Frame: Before and after 90 days intervention
  • Soluble P-Selectin
    • Time Frame: Before and after 90 days intervention
  • soluble CD40 ligand (sCD40L)
    • Time Frame: Before and after 90 days intervention
  • Syndecan-1
    • Time Frame: Before and after 90 days intervention
  • Soluble E-selectin
    • Time Frame: Before and after 90 days intervention
  • Tissue plasminogen activator
    • Time Frame: Before and after 90 days intervention

Participating in This Clinical Trial

Inclusion Criteria

  • HIV-1 infected
  • Can understand and sign written informed consent
  • Received one of the above mentioned antiretroviral regimens continuously ≥ 6 months
  • HIV RNA < 400 copies/mL for ≥ 6 months

Exclusion Criteria

  • Receiving anticoagulant therapy, adenosine diphosphate (ADP) receptor inhibitors, aspirin or nonsteroidal antiinflammatory drugs (NSAIDs)
  • Previous ischemic heart disease, peripheral atherosclerotic disease or stroke
  • Coagulation disorder (e.g. hemophilia, factor V Leiden mutation)
  • Platelet count < 150 x 109/L during the past 6 months from inclusion
  • Estimated glomerular filtration rate (eGFR) <70 during the past 6 months from inclusion
  • Humane leukocyte antigen (HLA)-B*57:01 positive genotype
  • Hepatitis B or C positive during the past year from inclusion
  • Hypersensitivity to the active substances or to any of the excipients

Gender Eligibility: Male

Minimum Age: 35 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jan Gerstoft
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Jan Gerstoft, MD, DMSc, Professor – Rigshospitalet, Denmark
  • Overall Official(s)
    • Jan Gerstoft, MD, DMSc, Principal Investigator, Rigshospitalet, Denmark

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