Tenofovir Abacavir Platelet Activation Study
- Registration Number
- NCT02093585
- Lead Sponsor
- Jan Gerstoft
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 43
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Tenofovir to abacavir abacavir (600 mg QD) Patients switching from tenofovir (245 mg QD) to abacavir (600 mg QD) Abacavir to tenofovir tenofovir (245 mg QD) Patients switching from abacavir (600 mg QD) to tenofovir (245 mg QD)
- Primary Outcome Measures
Name Time Method Differences in platelet aggregation (Multiplate) before and after switching between abacavir and tenofovir. before and after 90 days intervention Differences in clot formation kinetics (thromboelastography) before and after switching between abacavir and tenofovir. before and after 90 days intervention
- Secondary Outcome Measures
Name Time Method Concentration of plasma lipids Before and after 90 days intervention D-dimer Before and after 90 days intervention Fibrinogen Before and after 90 days intervention activated partial thromboplastin time (APTT) 90 days international normalized ratio (INR)/Factor II, VII, X Before and after 90 days intervention High sensitivity C reactive protein (HS-CRP) Before and after 90 days intervention Antithrombine Before and after 90 days intervention Syndecan-1 Before and after 90 days intervention Interleukin 6 (IL-6) Before and after 90 days intervention Platelet count Before and after 90 days intervention Soluble P-Selectin Before and after 90 days intervention soluble CD40 ligand (sCD40L) Before and after 90 days intervention Tissue plasminogen activator Before and after 90 days intervention Soluble E-selectin Before and after 90 days intervention
Trial Locations
- Locations (1)
Rigshospitalet, Klinik for Infektionsmedicin og Reumatologi, 8622
🇩🇰Copenhagen Ø, Copenhagen, Denmark