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临床试验/NCT03221309
NCT03221309已完成不适用

A Novel Model of Hepatitis C Treatment as Anchor to Prevent HIV, Initiate Opioid Substitution Therapy, and Reduce Risky Behavior

University of Maryland, Baltimore4 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
198
试验地点
4
主要终点
Hepatitis C Virus (HCV) Cure (Sustained Virologic Response)

研究概览

简要总结

This is an open label, non-randomized, observational pilot study to evaluate a model of care for treatment of hepatitis C in people with ongoing injection drug use. Participants will be treated with direct-acting antivirals (DAA) as per standard of care and will concomittantly be offered pre-exposure prophylaxis for HIV prevention and buprenorphine for treatment of opioid use disorder when clinically indicated.

详细描述

Hepatitis C (HCV) is a chronic infection with significant morbidity and mortality. The development of directly acting antivirals (DAA) has dramatically improved the cure rate of HCV treatment. However, despite the availability of effective therapy, the global epidemic of HCV infection continues to be driven by people with ongoing injection drug use (PWID), who are largely excluded from HCV therapy. Several critical barriers exist preventing high-risk patients' entry to care, including (1) lack of engagement in the traditional healthcare system by marginalized patient populations, and (2) insurance restrictions due to concerns regarding treatment adherence and HCV reinfection. Furthermore, ongoing injection drug use places these individuals at high risk of HIV acquisition. However, studies have repeatedly demonstrated that pre-exposure prophylaxis (PrEP) reduces HIV acquisition and opioid substitution therapy with buprenorphine reduces HIV and HCV acquisition in PWID.

As such, we propose a comprehensive model of care to engage individuals with ongoing injection drug use in treatment of HCV, in conjunction with collocated services to prevent HIV acquisition and HCV reinfection, including pre-exposure prophylaxis and opioid substitution therapy. This pilot trial will demonstrate whether a comprehensive model of care can simultaneously treat HCV, and prevent HCV reinfection, HIV acquisition and effectively treat opioid use disorder.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Age 18 years old
  • Able and willing to sign informed consent
  • Chronically infected with HCV, defined as any individual with documentation of positive HCV antibody and positive HCV RNA test (HCV RNA of 2,000 IU/mL or greater).
  • Willing to have samples stored for future use
  • Ongoing injection drug use, defined as self-report of either:
  • Phase 1 (first 100 enrolled participants) Injection non-prescription drug use within three months of screening visit or
  • Phase 2 (enrolled participants 101-200) Use of non-prescription opioids within twelve months of screening visit

排除标准

  • Decompensated liver disease (Childs Pugh B or C)
  • Unable to comply with research study visits
  • Poor venous access not allowing screening laboratory collection
  • Have any condition that the investigator considers a contraindication to study participation
  • Pregnant or breastfeeding woman

研究组 & 干预措施

Adults infected with HCV

Phase 1 (first 100 enrolled participants) HCV-infected adults with on-going injection drug use use with opioids with 3 months of screening

Phase 2 (enrolled participants 101-200) HCV-infected adults with on-going opioid misuse of non-prescription opioids within twelve months of screening

干预措施: Evaluate model of care for HCV-infected adults with on-going opioid misuse (Other)

结局指标

主要结局

Hepatitis C Virus (HCV) Cure (Sustained Virologic Response)

时间窗: 24 weeks

Undetectable HCV viral load 12 weeks after the end of treatment

次要结局

  • Uptake of HIV Pre-exposure Prophylaxis (PrEP)(24 weeks)
  • Retention on HIV PrEP(48 weeks)
  • Uptake of Buprenorphine(24 weeks)
  • Retention in Buprenorphine Program(48 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elana Rosenthal

Principal Investigator

University of Maryland, Baltimore

研究点 (4)

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