Inflammation Clinical Trial
Official title:
Targeted Anticoagulation Therapy to Reduce Inflammation and Cellular Activation in Long-term HIV Disease
The purpose of this study is to evaluate the effects of pharmacologic FXa inhibition (via edoxaban 30 mg daily) on inflammation, as reflected in plasma Interleukin-6 levels.
We hypothesize that increased generation of activated factor X (FXa) contributes to a
systemic elevation in pro-inflammatory cytokine levels (e.g. IL-6) among HIV positive
patients. This occurs, in part, via FXa activation of protease activated receptor 2 (PAR-2)
on monocytes and tissue macrophages, which perpetuates innate inflammation. We will test our
hypothesis with an oral antagonist to FXa (edoxaban), and quantify the immunologic effects of
PAR-2 inhibition on systemic inflammation and monocyte activation.
The potential benefits of pharmacologic inhibition of FXa will be studied among HIV positive
participants receiving ART with suppressed HIV viral load and a D-dimer >100 ng/mL. The study
design is a cross-over placebo controlled randomized trial of edoxaban 30mg daily versus
matched placebo (n=40 total participants). After screening and baseline visits, participants
will be randomized to the sequence of drug administration (i.e., edoxaban vs. placebo). After
randomization, participants will start study medication #1 and follow-up for visits at months
1, 2, 3 and 4. They will then stop study medication for 3 months, return for visits at months
7 and 8 (analogous to screening and baseline, respectively), then start study medication #2
and follow-up for visits at months 9, 10, 11, and 12.
The treatment effect (i.e., changes from pre-treatment levels) over 4 months will be assessed
in measures of inflammation, immune activation, and coagulation. For comparisons with
placebo, each participant will then serve as his or her own control in this cross-over
design.
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