Modulation of Immune Activation by Aspirin

This was a phase II prospective, double-blind, randomized, placebo-controlled 3-arm clinical trial to study whether aspirin improves inflammation and immune activation. At study entry, participants were randomized between the three study arms: aspirin 300 mg, aspirin 100 mg and placebo. The study treatment duration was 12 weeks, followed by a 4 week washout period. The study duration was 16 weeks. The study clinic visits included pre-entry (within 7 days prior to entry), entry, on treatment visits at weeks 2, 11 and 12, and final study visit at the end of the wash-out period at week 16. The samples for the primary and secondary outcomes were collected at pre-entry, entry, and weeks 2, 11 and 12. The evaluations of safety (clinical assessment for signs and symptoms, diagnoses, laboratory tests) were done at entry and weeks 2, 11, 12 and 16. The co-primary objectives used pair-wise comparisons to assess the effects of 300 mg and 100 mg of daily aspirin for 12 weeks on plasma sCD14 levels.