Phase 2
N=44
Targeted Anticoagulation Therapy to Reduce Inflammation and Cellular Activation in Long-term HIV Disease
Inflammation · Coagulation · HIV Infection
Bottom Line
View on ClinicalTrials.gov: NCT02339415 ↗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
| Outcome | Result | p-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.
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.