Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
Not provided
Not provided
Not provided
To demonstrate that colocation treatment of substance use disorder and Hepatitis C infection concurrently while proving addiction counselling will achieve increased duration of sobriety and elimination of Hepatitis C virus in study participants.
To demonstrate that colocation treatment of substance use disorder and Hepatitis C infection concurrently while proving addiction counselling will achieve increased duration of sobriety and elimination of Hepatitis C virus in study participants.
Primary objective:
1. Cure rates (SVR-12, HCV plasma RNA not quantifiable 12 weeks after last dose of treatment) of HCV in 30 recently identified PWIDS under 30 years old
Secondary objectives:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label Treatment Arm | Experimental | Treatment arm using Glecaprevir-pibrentasvir for treatment of all patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glecaprevir-pibrentasvir | Drug | Glecaprevir-pibrentasvir will be dispensed to 30 patients recently detoxed off heroin in an acute detox center. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cure rate of Hepatitis C Infection | Cure rates (SVR-12, HCV plasma RNA not quantifiable 12 weeks after last dose of treatment) of HCV in 30 recently identified PWIDS under 30 years | 12 weeks after treatment completion viral load measure |
| Measure | Description | Time Frame |
|---|---|---|
| Sobriety from Drug Use | Rate of sobriety maintenance for 1 year after enrollment | 1 year |
| Hepatitis C Reinfection Rate | Re-infection rate with HCV over 1 year after enrollment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Cirrhosis
Co-infection with HIV or HBV
Inability to comply with treatment or follow up
Renal failure with GFR less than 50 mL/min5*
Any prior treatment for HCV
Diabetes with HgA1c more than 8.0
Clinically significant abnormalities, other than HCV infection, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG) that make the subject an unsuitable candidate for this study in the opinion of the investigator, including, but not limited to:
Any uncontrolled psychiatric, cardiac, respiratory, gastrointestinal, hematologic, neurologic, psychiatric, or other medical disease or disorder, which is unrelated to the existing HCV infection which in the opinion of the PI would prevent adherence to and participation in the trial.
Hypersensitivity to naltrexone or polylactide-co-glycolide (PLG) microspheres
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ronald Nahass, MD | Contact | 9082810221 | rnahass@idcare.com | |
| Kathleen Seneca, MSN, APN | Contact | 9082810221 | kseneca@idcare.com |
| Name | Affiliation | Role |
|---|---|---|
| Ronald Nahass, MD | Id Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ID CARE | Hillsborough | New Jersey | 08844 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
| ID | Term |
|---|---|
| C000654128 | glecaprevir and pibrentasvir |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 year |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |