Inflammation Clinical Trial
— TACTICAL-HIVOfficial title:
Targeted Anticoagulation Therapy to Reduce Inflammation and Cellular Activation in Long-term HIV Disease
NCT number | NCT02339415 |
Other study ID # | PCC-008 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | July 2015 |
Est. completion date | September 2018 |
Verified date | August 2019 |
Source | Hennepin Healthcare Research Institute. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | September 2018 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Hennepin County Medical Center | Minneapolis | Minnesota |
United States | Hennepin County Medical Center | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Hennepin Healthcare Research Institute. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety (Bleeding Events) | Number of bleeding events on Edoxaban or Placebo. | 4 months while on Edoxaban or Placebo | |
Primary | Change in Interleukin 6 (IL-6) Plasma Levels From Baseline to 4 Months. | Difference between treatment and control ln-transformed IL-6 plasma levels in change from pre-treatment to on-treatment values | Through study completion, an average of 4 months on each treatment. | |
Secondary | Change in D-Dimer Levels From Baseline to 4 Months | Difference between treatment and control ln-transformed D-Dimer levels in change from pre-treatment to on-treatment values | Through study completion, an average of 4 months on each treatment. |
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