Effect of Aspirin on Abacavir-induced Platelet Reactivity in HIV-infected Patients (ABC-ASA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03316534|
Recruitment Status : Completed
First Posted : October 20, 2017
Last Update Posted : October 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV-infected Patients||Drug: Aspirin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||HIV subjects (all on ABC therapy) who fulfilled thee admission criteria will be randomized to either of 2 groups (A or B) with 20 subjects each that received placebo or aspirin (100 mg/daily) for two weeks. At the end of the two week period (T15), patients of group A will be switched to placebo, while group B will be switched to aspirin for another 2 weeks (T30). Adherence will be confirmed by pill count at the end of each study period.|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Aspirin on Abacavir-induced Platelet Reactivity in HIV-infected Patients|
|Actual Study Start Date :||January 2, 2017|
|Actual Primary Completion Date :||April 30, 2017|
|Actual Study Completion Date :||October 12, 2017|
Placebo Comparator: Placebo
Aspirin (100 mg once a day)
Active Comparator: Aspirin
Aspirin (100 mg/daily)
Aspirin (100 mg once a day)
- Platelet reactivity [ Time Frame: Change from baseline at day 15 and at day 30. ]PFA-100® collagen/epinephrine (C/EPI) cartridge closure time; light transmission aggregometry induced by arachidonic acid (1mM), collagen (0.8, 1.2 and 2 microg/ml) and epinephrine (100 microM); PAC-1; soluble P-selectin; sCD40L; platelet microparticles detection and quantification.
- Serum TxB2 levels and urinary 11-dehydro-TxB2 levels [ Time Frame: Change from baseline at day 14 after aspirin intake. ]