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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03995979 -
Inflammation and Protein Restriction
|
N/A | |
Completed |
NCT03255187 -
Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT03577223 -
Egg Effects on the Immunomodulatory Properties of HDL
|
N/A | |
Completed |
NCT04383561 -
Relationship Between LRG and Periodontal Disease
|
N/A | |
Active, not recruiting |
NCT03622632 -
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
|
||
Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
Completed |
NCT04856748 -
Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
|
||
Completed |
NCT05529693 -
Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population
|
N/A | |
Recruiting |
NCT05670301 -
Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases
|
N/A | |
Recruiting |
NCT05415397 -
Treating Immuno-metabolic Depression With Anti-inflammatory Drugs
|
Phase 3 | |
Recruiting |
NCT05775731 -
Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
|
||
Recruiting |
NCT04543877 -
WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study
|
Early Phase 1 | |
Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
Completed |
NCT03429920 -
Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors
|
N/A | |
Completed |
NCT06065241 -
Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals.
|
N/A | |
Completed |
NCT05864352 -
The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
|
||
Completed |
NCT03318731 -
Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males
|
N/A | |
Not yet recruiting |
NCT06134076 -
Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota
|
N/A | |
Not yet recruiting |
NCT06159543 -
The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes
|
N/A |