Evaluation of a Multi-disciplinary Approach for the Treatment of Hepatitis C in IDUs (HI-LO Study)
2016年11月28日 更新者：University of British Columbia
Although injection drug users (IDUs) account for over 70% of new cases of HCV infection/year, there is no consensus on how to approach their medical care.
In some Canadian centres, patients must be free of recreational drug use for as long as 6 months before being considered for HCV therapy.
This is not consistent with current North American guidelines.
Over the past 5 years, we have developed a successful program for the treatment of HIV infection in this population, based on a multi-disciplinary comprehensive program including directly observed therapy (DOT).
Even though the duration of therapy for HCV is shorter than for HIV (as little as 6 months vs. life-long), we must address issues of administration of a weekly injection (interferon), twice daily pills (ribavirin) and the risk of significant side effects (including anxiety and depression) to successfully expand our program to treat this disease.
Further, it may be that even if the program is successful, its benefits will be negated by HCV re-infection due to continued risk behaviors for its transmission.
研究概览
地位
完全的
条件
详细说明
We will determine the HCV infection status of potential study subjects within a cohort of 2,000 IDUs receiving care in our centres (Appendix 1).
For those who carry HCV antibodies (expected n = 1800), a test for HCV viremia and genotype will be performed.
By these evaluations, we expect up to 600 individuals to be viremic and carry HCV genotype 2 or 3. Within this group, 200 consecutive patients (100/study strategy) will receive therapy for HCV, based on their eligibility to do so according to Provincial guidelines for the reimbursement of medications.
Patient allocation will be according to the study site where they regularly receive care.
At two sites, patients will be enrolled in a DOT program with on-site full-time nursing and counseling support (high intensity, 50 patients/site).
At the other two sites, patients will receive medication on a weekly basis and will have access to part-time nursing and counseling support (low intensity, 50 patients/site).
Medical follow-up will be according to current clinical standards, and the primary endpoint of the study will be the rate of sustained virologic response (SVR) six months after completion of treatment.
Within the study described above, we will use standardized methodologies to calculate the total health care costs related to the treatment of HCV infection.
We will also assess the effect of treatment on the quality of life (QoL) of study participants.
研究类型
介入性
注册 (实际的)
370
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
British Columbia
-
Vancouver、British Columbia、加拿大、V6B 1R3
- Pender Community Health Centre
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
19年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age > 19 years;
- Serum HCV-RNA pos;
- HCV genotype 2 or 3;
- HBsAg neg;
- serum ALT > 1.5x upper limit normal > 3 months;
- Illicit drug use in the past year;
- Agreement from each participant of childbearing age to practice contraception;
- Absence of other contraindications to the initiation of therapy as determined by the health care team;
- Ability to provide informed consent.
Exclusion Criteria:
- Any cause for chronic liver disease other than HCV (including alcohol use >350 g/wk);
- Pregnant or breastfeeding women;
- Active HBV infection;
- Hemolytic anemia;
- Decompensated cirrhosis or portal hypertension or PT-INR > 1.3 or Child-Hugh class > A;
- Active suicidal ideation, psychosis, mania or hypomania;
- Serum creatinine > 180 µg/mL;
- Hemoglobin < 120 g/L in men or 110 g/L in women;
- Platelets < 90 x 109/L;
- Neutrophils < 1.5 x 109/L;
- Active autoimmune disease;
- NYHA disease > grade 2;
- Psoriasis requiring systemic therapy;
- Active malignancy apart from non melanoma skin cancer;
- Use of systemic immunosuppressant agents;
- Prior treatment of HCV with interferon or ribavirin;
- HIV positive with CD4 count <300 cells/mm3 or receiving didanosine (due to interaction with ribavirin);
- Life expectancy < 2 years.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：1
The 4 participating sites are designated either High Intensity or Low Intensity.
High Intensity sites have access to: full time specialist physicians, access to full time nurses and counselors.
All weekly pegylated interferon injections will be administered by clinic staff and ribavirin will be dispensed in weekly medication pack.
|
Weekly pegylated interferon injections will be administered by clinic staff and ribavirin will be dispensed in weekly medication pack.
Patients will be offered the option of self or nurse administered pegylated interferon injections on an appointment basis.
Ribavirin will be dispensed biweekly.
The treatment medication cannot be stored at the clinic; it must be the subjects responsibility.
|
|
有源比较器：2
The 4 participating sites are designated either High Intensity or Low Intensity.
In the Low intensity group, all patients will have access to: full time primary care physicians, specialist physicians and access to part time nurse or counselor by appointment.
Patients will be offered the option of self or nurse administered pegylated interferon injections on an appointment basis.
Ribavirin will be dispensed biweekly.
The treatment medication cannot be stored at the clinic; it must be the subjects responsibility.
|
Weekly pegylated interferon injections will be administered by clinic staff and ribavirin will be dispensed in weekly medication pack.
Patients will be offered the option of self or nurse administered pegylated interferon injections on an appointment basis.
Ribavirin will be dispensed biweekly.
The treatment medication cannot be stored at the clinic; it must be the subjects responsibility.
|
研究衡量的是什么？
主要结果指标
结果测量 |
|---|
|
Rate of sustained virologic response (SVR) six months after completion of treatment.
|
次要结果测量
结果测量 |
|---|
|
生活质量
|
|
成本
|
|
Adherence to therapy
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Brian Conway, MD、University of British Columbia
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年6月1日
初级完成 (实际的)
2010年8月1日
研究完成 (实际的)
2012年12月1日
研究注册日期
首次提交
2006年11月14日
首先提交符合 QC 标准的
2006年11月14日
首次发布 (估计)
2006年11月15日
研究记录更新
最后更新发布 (估计)
2016年11月30日
上次提交的符合 QC 标准的更新
2016年11月28日
最后验证
2016年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.