CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 34 enrolled
Drug / intervention
Harvoni (Fixed dose combination ledipasvir/sofosbuvir)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02347345
NCT02347345Phase 4Completed

The Immunologic Effects of HCV Therapy With Fixed Dose Combination Ledipasvir/Sofosbuvir (HARVONI) in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs.

Rockefeller University·interventional·Posted Jan 27, 2015·Updated Aug 13, 2019

In Brief

A Phase 4 clinical trial evaluating Harvoni (Fixed dose combination ledipasvir/sofosbuvir) for Hepatitis C. Completed, enrolled 34 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesUnited States

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 27, 2015
Enrollment StartNov 15, 2016
Primary CompletionNov 15, 2016
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 11.4 years ago

Interventions

Harvoni (Fixed dose combination ledipasvir/sofosbuvir)drug

Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill daily x 12 weeks