HIV-infected Patients Clinical Trial
Official title:
Effect of Aspirin on Abacavir-induced Platelet Reactivity in HIV-infected Patients
The specific research questions addressed in the present study are:
- to investigate the impact of treatment with low-dose aspirin in HIV-1-infected patients
treated with ABC and test it would result in decreased in vivo platelet activation and
platelet hyperreactivity
- to investigate if aspirin has the same effects in HIV-infected as in HIV-uninfected
patients.
Highly active antiretroviral therapy (HAART) may reduce the deleterious effects of HIV on the
cardiovascular system by decreasing viral load and chronic inflammation; however some
antiretrovirals enhance cardiovascular risk due to direct adverse effects on platelets or the
endothelium.
Abacavir/lamivudine (ABC/3TC) and tenofovir/emtricitabine (TDF/FTC) are the most widely used
nucleoside reverse transcriptase inhibitor (NRTI) associations in HAART. ABC has been
initially considered as one of the most benign antiretroviral drugs due to a better metabolic
profile than other nucleoside analogues, but since the D.A.D. study reported an association
between the use of ABC and an increase in cardiovascular risk there has been controversy
around this drug.
Clinical evidence suggests that in vivo platelet activation and platelet hyperreactivity
contribute to adverse cardiovascular events and hyperreactive platelets may transform a
normal reparative response to a mild arterial injury into an unwanted thrombotic event.
Aspirin is the cornerstone in the prevention of atherothrombotic events, as it has been shown
to be effective both in the primary and secondary prevention of MI (6), and its beneficial
effects likely involve the modulation of inflammatory and immune pathways. But despite
heightened awareness regarding elevated CVD risk among HIV-infected patients, aspirin or
others antiplatelet therapy were markedly underprescribed among HIV-infected patients at risk
for CVD events (7).
Based on this, the proposed study will assess whether low-dose aspirin, in well-characterized
HIV-1-infected patients treated with ABC, would result in decreased in vivo platelet
activation and platelet hyperreactivity. Moreover will be investigate if aspirin will have
the same effects in HIV-infected as in HIV-uninfected patients.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02827227 -
Values of the Immune Activation Markers CD38 and HLA-DR and the Ratio CD4/CD8 According to the Delay of Combined AntiRetroviral Therapy (c-ART) Initiation in Primary HIV-infected Patients (PRIMIMMUNO)
|
N/A |