Effect of Aspirin on Abacavir-induced Platelet Reactivity in HIV-infected Patients

NCT03316534 | Completed Phase 2

• 1 other identifier: 1452/13/ACC
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV-infected Patients

Outcome Measures

Primary Outcomes (1)

• Platelet reactivity

  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.

  Change from baseline at day 15 and at day 30.

Secondary Outcomes (1)

• Serum TxB2 levels and urinary 11-dehydro-TxB2 levels

  Change from baseline at day 14 after aspirin intake.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Aspirin

Aspirin

ACTIVE COMPARATOR

Aspirin (100 mg/daily)

Drug: Aspirin

Interventions

Aspirin DRUG

Aspirin (100 mg once a day)

Aspirin; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera di Perugia: lead

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, Internal Medicine

Model Details: 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.

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 20, 2017
• Study Start: January 2, 2017
• Primary Completion: April 30, 2017
• Study Completion: October 12, 2017
• Last Updated: October 20, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share