Immunologic Effects of HCV Therapy With HARVONI in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs
Status:
Completed
Trial end date:
2016-11-15
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
Rockefeller University
Collaborator:
National Institute on Drug Abuse (NIDA)
Treatments:
Ledipasvir Ledipasvir, sofosbuvir drug combination Sofosbuvir