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

NCT02339415 | Completed Phase 2 Results DMC

• 1 other identifier: PCC-008
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Inflammation; Coagulation; HIV Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in D-Dimer Levels From Baseline to 4 Months

  Through study completion, an average of 4 months on each treatment.

Other Outcomes (1)

• Safety (Bleeding Events)

  4 months while on Edoxaban or Placebo

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Edoxaban 30mg daily

Drug: Edoxaban 30mg daily

Placebo

PLACEBO COMPARATOR

Matching Placebo

Drug: Matching placebo

Interventions

Edoxaban 30mg daily DRUG

Treatment

Matching placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)
• 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.

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead

Study Sites (2)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

Inflammation; Thrombosis; HIV Infections

Interventions

edoxaban

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Jason Baker
• Organization: Hennepin Healthcare Research Institute

baker@umn.edu

612-873-2705

Study Officials

• Jason Baker, M.D.

  Hennepin Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Protocol Chair

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: January 15, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 6, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-08

Locations

US (2)