Immunologic Effects of HCV Therapy With HARVONI in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs

Completed · Phase 4

Conditions studied: Hepatitis C

In brief

The investigator's hypothesis is that active injectors will show a partial reduction in markers of immune activation with HCV therapy whereas non-injectors will show a more significant reduction in these markers, and will exhibit levels of immune activation that approach that seen in similarly studied healthy volunteers.This is based on observations that this group of investigators have made. They have shown that individuals who inject drugs have high level of immune activation in blood and tissue. Immune activation or chronic inflammation has been associated with accelerated aging, cardiovascular, renal and liver disease as well as CNS dysfunction. It remains unclear whether increased levels of immune activation are due to non-sterile injection of drugs, chronic infection with Hepatitis C, chronic opiate use, or perhaps combinations of all 3. To understand the potential contribution of infection with Hepatitis C the investigators will compare levels of immune activation pre- and post treatment with an all oral, one pill once daily, interferon sparing treatment of HCV in 2 groups of chronically HCV infected patients- one actively injecting with drugs and the other free of injection for at least 4 months. Immune activation comparisons will also include non-injecting healthy volunteers.

Key facts

Study ID

NCT02347345

Run by

Rockefeller University

People needed

34

Starts

2016-11-15

Expected to finish

2016-11-15

Last updated by the study team

2019-08-13

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ability to give written informed consent in English
• Age≥18 and ≤55
• HCV antibody positive
• HCV RNA >1,000 copies/mL plasma
• HCV treatment naive
• HCV genotype 1a or 1b or mixed type 1
• AST, ALT <10x ULN
• Direct bilirubin <3.0
• Platelet count >50,000
• Creatinine clearance >30mL/min as estimated by Cockroft Gault
• Hemoglobin >10 if female, >11 if male
• Albumin > 2.8
• INR<2.0
• If Group A: urine dip for opiates + and active injection drug use of heroin defined as injecting at least 3 times per week.
• If Group B then no IDU for at least 4 months and a negative urine for opiates at screening.
• Venous access for phlebotomy
• Willingness to agree to effective contraception during the course of the study.
• If Group C: - negative urine for opiates at screening
• no recreational drug use for at least 2 years (excluding marijuana)
• HIV, HCV and HBV uninfected

You may not qualify if…

• HIV infection
• Chronic infection with Hepatitis B
• Uncompensated cirrhosis
• Required use of:
• Anticonvulsants: carbamazepine, oxycarbazepine, phenobarbital, and phenytoin
• Antimycobacterials: rifabutin, rifampin, rifapentine
• Herbal Supplements: St. John's wort
• HIV Protease Inhibitors: tipranavir-ritonavir
• Antiarrhythmic Drugs: amiodarone (Cordarone, Nexterone, Pacerone)
• Any medical condition that in the opinion of the investigator would interfere with study participation and medical adherence
• Pregnancy/breast feeding

Where it is running

• Rockefeller University Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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