Changes in blood clotting and platelet reactivity in HIV infected patients switching between abacavir and tenofovir containing antiretroviral regimens

Conditions: HIV
MedDRA version: 14.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2013-001685-42-DK

Lead Sponsor: Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

•HIV-1 infected
•Can understand and sign written informed consent
•Male
•Between 35 and 70 years old at inclusion
•Received one of the above mentioned antiretroviral regimens continuously = 6 months
•HIV RNA < 400 copies/mL for = 6 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

•Receiving anticoagulant therapy, ADP-receptor inhibitors, aspirin or 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
•eGFR<70 during the past 6 months from inclusion
•HLA-B*57:01 positive genotype
•Hepatitis B or C positive during the past year from inclusion

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the present, interventional study is to investigate possible adverse effect of abacavir on platelet reactivity, coagulation and endothelial activation in HIV-1 infected patients.;Secondary Objective: not applicable;Primary end point(s): •Differences between platelet aggregation before and after switching between abacavir and tenofovir.<br>•Differences between thromboelastographic parameters before and after switching between abacavir and tenofovir.<br>;Timepoint(s) of evaluation of this end point: baseline and after 90 days intervention

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Differences between <br><br>olipids<br>omarkers of coagulation<br>omarkers of inflammation<br>omarkers of endothelial injury<br>omarkers of platelet reactivity<br>omarkers of fibrinolysis<br><br> before and after switching between abacavir and tenofovir.<br><br>•The effect of smoking on the above mentioned differences.<br>;Timepoint(s) of evaluation of this end point: baseline and after 90 days intervention