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Phase 2 N=44 Randomized Quadruple-blind Treatment

Targeted Anticoagulation Therapy to Reduce Inflammation and Cellular Activation in Long-term HIV Disease

Inflammation · Coagulation · HIV Infection

Enrolled (actual)
44
Serious AEs
2.3%
Results posted
Sep 2019
Primary outcome: Primary: Change in Interleukin 6 (IL-6) Plasma Levels From Baseline to 4 Months. — -0.02; 0.09 ln-pg/mL — p=0.26

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Edoxaban 30mg daily (Drug); Matching placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Hennepin Healthcare Research Institute
Primary completion
Sep 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Interleukin 6 (IL-6) Plasma Levels From Baseline to 4 Months.
-0.02; 0.09 0.26
SECONDARY
Change in D-Dimer Levels From Baseline to 4 Months
-0.13; -0.66 0.002 sig

Summary

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.

Eligibility Criteria

Inclusion Criteria

  • HIV infection (verified by previous positive antibody or detectable HIV RNA level)
  • Age ≥18 years
  • Receiving continuous ART for ≥2 years (regimen changes >3 months prior to enrollment are acceptable)
  • HIV RNA level ≤200 copies/mL for ≥1 year (1 measure ≥200 allowed if also 1.1 x ULN), hemoglobin (<10.0 g/L), platelets (<100,000 cells/μL), and WBC (2,500 cells/mm3)
  • Grade ≥2 lab abnormality for chemistries (BMP) or liver panel
  • Alcohol or illicit drug abuse/dependency within the prior year
  • History of prior myocardial infarction or unstable atherosclerotic disease
  • History of prior stroke or transient ischemic attack (TIA)
  • History of active gastrointestinal ulcer or bleeding disorder within the prior year
  • Intent to have surgery during the study period (12 months)
  • Hepatitis C treatments (e.g., interferon, ribavirin, protease inhibitors) within the past 6 months
  • Cirrhosis or hepatic impairment (e.g., Child-Pugh class B or C).
  • Seizure disorder
  • Previous/current CNS space occupying lesion (e.g., Toxoplasmosis, mTB) with persistent abnormalities on CNS imaging after completion of treatment.
  • Surgical or invasive procedure anticipated during study period.
  • Invasive cancer in the prior year or receiving cancer treatment (not including carcinoma-in-situ or basal cell cancer of the skin)
  • Rheumatologic or inflammatory disease, systemic in nature (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis, sarcoidosis, Crohn's disease)
  • Assessment by the clinical investigator that enrollment into the study could entail excess risk to the participant, beyond what is intended or expected.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02339415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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