Skip to main content
OpenTrials
Completed

NCT Number: NCT02093585

Tenofovir Abacavir Platelet Activation Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

35 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Rigshospitalet, Klinik for Infektionsmedicin og Reumatologi, 8622

Copenhagen Ø, Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

abacavir (600 mg QD)

Drug

tenofovir (245 mg QD)

Drug

Primary outcomes

  1. Differences in platelet aggregation (Multiplate) before and after switching between abacavir and tenofovir.

    Time frame: before and after 90 days intervention

  2. Differences in clot formation kinetics (thromboelastography) before and after switching between abacavir and tenofovir.

    Time frame: before and after 90 days intervention

Secondary outcomes

  1. Concentration of plasma lipids

    Time frame: Before and after 90 days intervention

  2. activated partial thromboplastin time (APTT)

    Time frame: 90 days

  3. international normalized ratio (INR)/Factor II, VII, X

    Time frame: Before and after 90 days intervention

  4. Platelet count

    Time frame: Before and after 90 days intervention

  5. Fibrinogen

    Time frame: Before and after 90 days intervention

  6. D-dimer

    Time frame: Before and after 90 days intervention

  7. Antithrombine

    Time frame: Before and after 90 days intervention

  8. Interleukin 6 (IL-6)

    Time frame: Before and after 90 days intervention

  9. High sensitivity C reactive protein (HS-CRP)

    Time frame: Before and after 90 days intervention

  10. Soluble P-Selectin

    Time frame: Before and after 90 days intervention

  11. soluble CD40 ligand (sCD40L)

    Time frame: Before and after 90 days intervention

  12. Syndecan-1

    Time frame: Before and after 90 days intervention

  13. Soluble E-selectin

    Time frame: Before and after 90 days intervention

  14. Tissue plasminogen activator

    Time frame: Before and after 90 days intervention

Sponsors and collaborators

Lead sponsor

Jan Gerstoft

Other

Registry information

Official study title

Changes in Coagulation and Platelet Reactivity in HIV-1 Infected Patients Switching Between Abacavir and Tenofovir Containing Antiretroviral Regimens

Acronym: TAPAS

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Mar 21, 2014
Registry last updated
Apr 11, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.