Curing HCV in Incarcerated Patients

NCT03018353 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: IN-US-337-1941
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis C, Chronic; Jail; Patient Navigation; Incarcerated Population; HCV; Sofosbuvir/Velpatasvir; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Navigation services with sof/vel therapy

OTHER

This a single group demonstration project in which, patients are treated with the FDA-approved drug, Sofosbuvir/Velpatasvir (Epclusa). If a patients is released during their treatment regimen, they will receive patient navigation services to continue their care and treatment in the community.

Drug: Patients receiving Sof/Vel (Epclusa) and Navigation services

Interventions

Patients receiving Sof/Vel (Epclusa) and Navigation services DRUG

Implementing HCV treatment in the jails using FDA-approved medications and continuing there treatment in the community if they are released during their treatment regimen.

Navigation services with sof/vel therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• San Francisco Department of Public Health: lead
• University of California, San Francisco: collaborator
• San Francisco Study Center: collaborator
• Gilead Sciences: collaborator

Study Sites (1)

Jail Health Services

San Francisco, California, 94103, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Jail Health Services

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 12, 2017
• Study Start: March 5, 2017
• Primary Completion: March 4, 2018
• Study Completion: June 4, 2018
• Last Updated: June 1, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)