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

Changes in coagulation and platelet reactivity in HIV-1 infected patients switching between abacavir and tenofovir containing antiretroviral regimens - TAPAS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-001685-42-DK
Enrollment
Unknown
Registered
2013-06-21
Start date
2013-06-21
Completion date
Unknown
Last updated
2015-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV MedDRA version: 14.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862

Interventions

Trade Name: Truvada Pharmaceutical Form: Tablet Trade Name: Kivexa Pharmaceutical Form: Tablet

Sponsors

Rigshospitalet
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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. • Differences between thromboelastographic parameters before and after switching between abacavir and tenofovir. ;Timepoint(s) of evaluation of this end point: baseline and after 90 days intervention—

Secondary

MeasureTime frame
Secondary end point(s): • Differences between o lipids o markers of coagulation o markers of inflammation o markers of endothelial injury o markers of platelet reactivity o markers of fibrinolysis before and after switching between abacavir and tenofovir. • The effect of smoking on the above mentioned differences. ;Timepoint(s) of evaluation of this end point: baseline and after 90 days intervention—

Countries

Denmark

Contacts

Public ContactInfektionsmedicinsk Amb. 5112

Rigshospitalet

frederikkefr@gmail.com+4535457726

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026