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Effect of Aspirin on Abacavir-induced Platelet Reactivity in HIV-infected Patients (ABC-ASA)

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ClinicalTrials.gov Identifier: NCT03316534
Recruitment Status : Completed
First Posted : October 20, 2017
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Paolo Gresele, Azienda Ospedaliera di Perugia

Brief Summary:

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

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
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)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Aspirin
Aspirin (100 mg once a day)

Active Comparator: Aspirin
Aspirin (100 mg/daily)
Drug: Aspirin
Aspirin (100 mg once a day)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Serum TxB2 levels and urinary 11-dehydro-TxB2 levels [ Time Frame: Change from baseline at day 14 after aspirin intake. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • a viral load <50 copies per millilitre
  • ABC treatment for at least 6 months

Exclusion Criteria:

  • age younger than 18
  • nonsteroidal anti-inflammatory drug use in the past week (including aspirin), renal failure (creatinine clearance <30 mL/min), platelet count <100,000/microL, history of gastrointestinal bleeding within the last 6 months, presence of coexisting inflammatory disease, cancer, active bacterial or fungal infection, bleeding history, oral anticoagulant therapy and allergy to aspirin

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Responsible Party: Paolo Gresele, Full Professor, Internal Medicine, Azienda Ospedaliera di Perugia
ClinicalTrials.gov Identifier: NCT03316534     History of Changes
Other Study ID Numbers: 1452/13/ACC
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Aspirin
Abacavir
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents