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

Completed · Phase 2 · Has a placebo group

Conditions studied: Inflammation, Coagulation, HIV Infection

In brief

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.

Key facts

Study ID

NCT02339415

Run by

Hennepin Healthcare Research Institute

People needed

44

Starts

2015-07-01

Expected to finish

2018-09-01

Last updated by the study team

2019-09-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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