HIV
Conditions
Keywords
HIV-1, Abacavir, Platelet activation, Thromboelastography, Coagulation
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.
Interventions
DRUGabacavir (600 mg QD)
DRUGtenofovir (245 mg QD)
Sponsors
Jan Gerstoft
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
35 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Syndecan-1 | Before and after 90 days intervention |
| Soluble E-selectin | Before and after 90 days intervention |
| Tissue plasminogen activator | Before and after 90 days intervention |
| Concentration of plasma lipids | 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 |
| Soluble P-Selectin | Before and after 90 days intervention |
| Fibrinogen | Before and after 90 days intervention |
| D-dimer | Before and after 90 days intervention |
| Antithrombine | Before and after 90 days intervention |
| Interleukin 6 (IL-6) | Before and after 90 days intervention |
| High sensitivity C reactive protein (HS-CRP) | Before and after 90 days intervention |
| Platelet count | Before and after 90 days intervention |
| soluble CD40 ligand (sCD40L) | Before and after 90 days intervention |
Countries
Denmark
Outcome results
None listed