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临床试验/NCT01442311
NCT01442311已完成不适用

Directly Observed Hepatitis C Treatment in Methadone Clinics

Albert Einstein College of Medicine2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2007年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Adherence

研究概览

简要总结

Drug users account for a disproportionately large burden of hepatitis C virus (HCV) infection. However, HCV treatment adherence rates in drug users may be suboptimal in patients who use drugs regularly during HCV treatment. Because HCV treatment is most effective when patients adhere to at least 80% of the prescribed treatment regimen, interventions to improve HCV treatment adherence need to be developed and evaluated. The investigators designed the HCV DOT trial to test the efficacy of two versions of modified directly observed HCV therapy provided on-site at a methadone clinic. The primary objective of this trial is to determine whether enhanced DOT with both pegylated interferon alfa-2a plus ribavirin (PEG/RBV-DOT) is more efficacious than standard DOT with weekly provider-administered pegylated interferon (PEG-DOT) and self-administered ribavirin for increasing adherence and improving HCV treatment outcomes. The investigators hypothesize that PEG/RBV-DOT is associated with increased adherence and rates of sustained viral response compared with PEG-DOT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • HCV-infected
  • receive HCV medical care at the methadone clinic
  • plan to initiate HCV treatment on-site within the next 3 months
  • psychiatrically stable as determined by HCV treatment provider and/or on-site psychiatrist
  • attend the methadone clinic between three and six days per week to receive methadone
  • stable dose fo methadone for two weeks prior to the baseline visit

排除标准

  • unable or unwilling to provide informed consent
  • currently receiving HCV treatment
  • primary HCV care provider does not agree to their participation in the trial
  • psychiatrically unstable

结局指标

主要结局

Adherence

时间窗: 24 -48 weeks

Adherence assessed by pill count, self-report, and medical records.

次要结局

  • end of treatment response (ETR)(24 - 48 weeks)
  • treatment completion(24 - 48 weeks)
  • sustained viral response (SVR)(24 weeks after treatment completion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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