The procoagulant state seen in patients with hiv can be a result of the immune activation due to the hiv infection itself or combination antiretroviral therapy (cART). In case the acquired thrombophilia is a result of immune activation, the…
ID
Bron
Verkorte titel
Aandoening
HIV, thrombophilia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Plasma levels of following markers:
- FVIII
- Anti-thrombin
- Protein C antigen
- Protein S antigen
- Free protein S
- Fibrinogen
- Lupus anticoagulans
- Von Willebrand factor
- D-dimer
Achtergrond van het onderzoek
Epidemiological studies have demonstrated that people living with hiv have an increased risk of developing venous thrombosis and cardiovascular disease than the general population. The pathophysiology of thrombosis is a complex and multifactorial process, in which the balance of procoagulant and anticoagulant activity is disturbed causing a thrombophilic state. Several factors in hiv-infection contribute to a procoagulant state. Earlier studies have demonstrated a decrease in anticoagulant factors, e.g. protein S en C, and an increase in procoagulant factors, e.g. D-dimer, fibrinogen and von Willebrand factor (vWF). However, the pathophysiology of this thrombophilic state in hiv-infection remains to be elucidated. Several studies have demonstrated that the thrombotic risk in hiv-infection is associated with chronic immune-activation and inflammation. On the other hand, combination antiretroviral therapy (cART) is also associated with an increased risk of venous thrombosis and cardiovascular disease. It is unclear whether the hiv-infection itself and its treatment could contribute to the thrombophilic state seen in hiv-infected patients.
In 2010, the INF-BEAST study was performed to evaluate the effect of cART in cART-naive hiv-infected. At start of cART, elevated levels of procoagulant factors and decreased levels of anticoagulant factors were found. After a year of cART, a subtle decrease in procoagulant and increase in anticoagulant factors were seen. Despite the initiation of cART therapy, the effect of persistent immune-activation and inflammation could not be ruled out, as suppression of immune activation is yet not achieved after one year of cART use. Currently no data is available on the long-term effect of cART on the thrombophilic state in hiv patients. In this study we aim to determine the thrombophilic state in the INF-BEAST patient population after almost eight years of treatment with cART.
Doel van het onderzoek
The procoagulant state seen in patients with hiv can be a result of the immune activation due to the hiv infection itself or combination antiretroviral therapy (cART). In case the acquired thrombophilia is a result of immune activation, the progcoagulant state should resolve after long term (cART).
Onderzoeksopzet
time of inclusion
Onderzoeksproduct en/of interventie
Questionnaire and blood sampling
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Inclusion in the original INF-BEAST study
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Declining informed consent to participate in the INF-BEAST2 study
Opzet
Deelname
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In overige registers
Register | ID |
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NTR-new | NL7884 |
Ander register | METC Groningen : METC2019/086 |