Overview

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.