Effective Treatment of Hepatitis C in Substance Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Number of Participants With a Sustained Virologic Response (SVR)
研究概览
简要总结
We hypothesize that integrating Hepatitis C into methadone and buprenorphine treatment will improve Hepatitis C outcomes as well as drug treatment outcomes in patients who are addicted to opiates. We will test this hypothesis by randomly assigning patients to receive integrated or separated care. The first group will receive Hepatitis C treatment and substance abuse treatment contemporaneously at the South Central Rehabilitation Center (SCRC). They will take both methadone or buprenorphine and Hepatitis C medications under the daily (methadone) or weekly (buprenorphine) observation of a health care provider. The second group will receive substance abuse treatment at SCRC, and go to another facility to receive Hepatitis C treatment services. These participants will take their medications on their own (without observation).
We will look at outcomes such as Hepatitis C viral loads, adherence to medications, and drug treatment outcomes such as receipt of buprenorphine and methadone and urine toxicology testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a DSM IV diagnosis of opioid dependence who are currently enrolled in methadone or buprenorphine maintenance at South Central Rehabilitation Center in good standing (opiate free urine with positive methadone or buprenorphine, respectively) for at least 30 days.
- •Hepatitis C infection as evidenced by a positive HCV antibody and a detectable HCV RNA.
排除标准
- •Suicidal or homicidal ideation
- •Psychiatric condition that is not stable
- •Pregnancy (RBV is a Class C drug during pregnancy)
- •Pending court case or warrant which would interrupt treatment
- •Decompensated cirrhosis (Child's Class B or C) or presence of hepatocellular carcinoma
- •HIV+ with CD4<200 or CD4>200 and VL>5,000 copies/mL
- •Platelet count < 75,000 /mL
- •Hemoglobin < 10 mg/dL
- •Absolute neutrophil count <1500 cells/mL
结局指标
主要结局
Number of Participants With a Sustained Virologic Response (SVR)
时间窗: 24 weeks (end of treatment)
SVR is defined as continued undetectable HCV viral load at 24 weeks
次要结局
未报告次要终点
研究者
R. Douglas Bruce, MD, MA
Assistant Professor
Yale University