Tenofovir Abacavir Platelet Activation Study

HIV Clinical Trial

— TAPAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02093585
• Other study ID #: 2013-001685-42
• Status: Completed
• Phase: Phase 4
• First received: March 18, 2014
• Last updated: April 10, 2018
• Start date: January 2014
• Est. completion date: June 2017

Study information

• Verified date: April 2018
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• abacavir (600 mg QD)

• tenofovir (245 mg QD)

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Klinik for Infektionsmedicin og Reumatologi, 8622	Copenhagen Ø	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Jan Gerstoft

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in platelet aggregation (Multiplate) before and after switching between abacavir and tenofovir.		before and after 90 days intervention
Primary	Differences in clot formation kinetics (thromboelastography) before and after switching between abacavir and tenofovir.		before and after 90 days intervention
Secondary	Concentration of plasma lipids		Before and after 90 days intervention
Secondary	activated partial thromboplastin time (APTT)		90 days
Secondary	international normalized ratio (INR)/Factor II, VII, X		Before and after 90 days intervention
Secondary	Platelet count		Before and after 90 days intervention
Secondary	Fibrinogen		Before and after 90 days intervention
Secondary	D-dimer		Before and after 90 days intervention
Secondary	Antithrombine		Before and after 90 days intervention
Secondary	Interleukin 6 (IL-6)		Before and after 90 days intervention
Secondary	High sensitivity C reactive protein (HS-CRP)		Before and after 90 days intervention
Secondary	Soluble P-Selectin		Before and after 90 days intervention
Secondary	soluble CD40 ligand (sCD40L)		Before and after 90 days intervention
Secondary	Syndecan-1		Before and after 90 days intervention
Secondary	Soluble E-selectin		Before and after 90 days intervention
Secondary	Tissue plasminogen activator		Before and after 90 days intervention