Hepatitis C, Chronic Clinical Trial
— CHIPOfficial title:
Curing HCV in Incarcerated Patients
Verified date | May 2017 |
Source | San Francisco Department of Public Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Curing HCV in Incarcerated Patients (CHIP) is a 1-year demonstration project that will assess the feasibility of a HCV treatment program in the San Francisco City & County Jail. The Jail Health Services will treat 100 patients using the FDA approved combination treatment, sofosbuvir/velpatasvir, Epclusa® and will continue their treatment during incarceration and after their release (if applicable).
Status | Enrolling by invitation |
Enrollment | 100 |
Est. completion date | June 4, 2018 |
Est. primary completion date | March 4, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - a detectable HCV viral load - no medical contraindications to treatment, including limited life expectancy of less than 12-months due to non-liver related comorbid conditions or renal failure with creatinine clearance of < 30 mL/min. - Must start HCV treatment while detained - HIV positive or negative status - HBV positive or negative status - treatment-naïve or experienced - with or without cirrhosis Exclusion Criteria: - a limited life expectancy of less than 12-months due to non-liver related comorbid conditions - current or history of decompensated cirrhosis, defined as presence of ascites, hepatic encephalopathy, or variceal bleeding within the past 6 months. - severe renal impairment defined as creatinine clearance of < 30 mL/min or end stage renal disease (ESRD) on hemodialysis - pregnant |
Country | Name | City | State |
---|---|---|---|
United States | Jail Health Services | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
San Francisco Department of Public Health | Gilead, Inc. Investigator Sponsored Research, San Francisco Study Center, University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SVR12 of 70% or greater | The primary objective is to implement a feasible HCV treatment program in an urban jail setting, City & County of San Francisco, over a 12 month period, with demonstration of a SVR12 of 70% or greater among inmates who initiates HCV treatment | 12 months |
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