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

• Status: Completed
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hennepin Healthcare Research Institute; Minneapolis Medical Research Foundation
• Treatments: Edoxaban

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 <500 and preceded and followed by one or more values ≤200 copies/mL)

• D-dimer level ≥100 mg/L (or ng/mL) at screening (or within the prior month)

• Estimated creatinine clearance ≥50 mL/min

• Body weight ≥60kg

• Do not anticipate starting (or stopping) statin or aspirin therapy during the study

• For women of child bearing potential, agrees to use a reliable form of birth control

Exclusion Criteria

• Pregnancy or breast feeding

• A contra-indication to taking edoxaban

• A clinical indication for anticoagulation therapy (e.g., atrial fibrillation or Deep Vein Thrombosis/PE)

• Treatment with anti-platelet, anti-coagulation, or immune-modulatory drugs currently or within the past 6 months; prior self-limited treatment with aspirin (i.e., not daily use) is not itself an exclusion.

• Grade ≥1 hematology lab abnormality for INR (>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.