Clinical trial NCT02339415 (phase 2, status: completed)
Conditions: inflammation, coagulation, hiv infection
ICD codes: H01.9, H30.93, H05.00, H30.003, H30.013, H30.033, H30.103, D68.9, O72.3, R79.1, D68.4, D68.8, D65, O67.0, Z21
Drugs: edoxaban 30mg daily, matching placebo
SMILES: CN(C)C(=O)[C@H]1CC[C@H](NC(=O)C(=O)NC2=NC=C(Cl)C=C2)[C@@H](C1)NC(=O)C1=NC2=C(CN(C)CC2)S1, CC1=CC(O)=CC(C)=C1Cl
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 <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.