Immunologic Effects of HCV Therapy With HARVONI in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs
Public ClinicalTrials.gov record NCT02347345. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The Immunologic Effects of HCV Therapy With Fixed Dose Combination Ledipasvir/Sofosbuvir (HARVONI) in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02347345
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 34 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 14, 2016
- Primary completion
- Nov 14, 2016
- Completion
- Nov 14, 2016
- Last update posted
- Aug 12, 2019
2016
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rockefeller University Hospital | New York | New York | 10021 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Recently updated Hepatitis C trials
Other public records listing Hepatitis C. Sorted by last update posted; newest first. Not a recommendation.
- NCT05181826: Collection of Blood From Healthy Patients, Patients With Benign Disease and Patients With Cancer Recruiting
- NCT02995252: The HOPE Study: Characterizing Patients With Hepatitis B and C Active, not recruiting
- NCT06409169: DBS TaT in Peer-assisted Telemedicine for Hepatitis C Active, not recruiting
- NCT01644903: Proteogenomic Monitoring and Assessment of Liver Transplant Recipients Recruiting
- NCT00001971: Evaluation of Patients With Liver Disease Recruiting
- NCT07040319: Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV Recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02347345, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 12, 2019 · Synced Sep 4, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02347345 live on ClinicalTrials.gov.