Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study Combining HCV and Addiction Treatment of Young Suburban Heroin Users (SHU) That Addresses Barriers to Care
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cure rate of Hepatitis C Infection
研究概览
简要总结
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.
详细描述
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:
- 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:
- Rate of sobriety maintenance for 1 year after enrollment
- Re-infection rate with HCV over 1 year after enrollment
- Re-admission rates for detox
- Cravings
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 30
- •Successfully detoxed at PHBH from opioids
- •Agree to participate in a closely monitored program
- •Positive HCV VL > 5,000 on two tests
- •Minimum one follow-up visit after discharge from PHBH to be enrolled
- •Any genotype
- •APRI less than 1 and Fibrosure less than 0.45
- •Negative pregnancy test in women and females must agree to acceptable contraception during treatment of HCV. Oral contraceptives that do not contain ethinyl estradiol are allowed with Mavyret
- •Treatment naïve for HCV
- •Signed informed consent
排除标准
- •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:
- •ALT/AST > 10x normal value,
- •WBC with ANC < 1500 cell/ul,
- •Hemoglobin < LLN,
- •Treatment for cancer or lymphoma in the past 5 years,
- •Hemoglobin A 1C > 8%.
- •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
研究组 & 干预措施
Open Label Treatment Arm
Treatment arm using Glecaprevir-pibrentasvir for treatment of all patients
干预措施: Glecaprevir-pibrentasvir (Drug)
结局指标
主要结局
Cure rate of Hepatitis C Infection
时间窗: 12 weeks after treatment completion viral load measure
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
次要结局
- Sobriety from Drug Use(1 year)
- Hepatitis C Reinfection Rate(1 year)
研究者
Ronald Nahass
Principle Invesigator
Id Care