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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenofovir to abacavir | Experimental | Patients switching from tenofovir (245 mg QD) to abacavir (600 mg QD) |
|
| Abacavir to tenofovir | Experimental | Patients switching from abacavir (600 mg QD) to tenofovir (245 mg QD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abacavir (600 mg QD) | Drug |
| ||
| tenofovir (245 mg QD) |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Gerstoft, MD, DMSc | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet, Klinik for Infektionsmedicin og Reumatologi, 8622 | Copenhagen Ø | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C106538 | abacavir |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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|
| Before and after 90 days intervention |
| Platelet count | 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 |
| Soluble P-Selectin | Before and after 90 days intervention |
| soluble CD40 ligand (sCD40L) | Before and after 90 days intervention |
| 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 |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |