Hepatitis C Virus InfectionNCT00399672
Evaluation of a Multi-disciplinary Approach for the Treatment of Hepatitis C in IDUs (HI-LO Study)
A study testing Interferon injections and ribavirin in people with Hepatitis C Virus Infection, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hepatitis C Virus Infection
- What is being tested?
- Interferon injections and ribavirin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2007to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Pender Community Health Centre
Vancouver, British Columbia, V6B 1R3
About this study
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.
Read the detailed description
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.
- Conditions
- Hepatitis C Virus Infection
- Being tested
- Interferon injections and ribavirin
- Keywords
- HCV, injection drug users, ribavirin, pegylated interferon, illicit drug users
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon injections and ribavirinDrug
Weekly pegylated interferon injections will be administered by clinic staff and ribavirin will be dispensed in weekly medication pack.
Interferon injections and ribavirinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 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. Receives: Drug: Interferon injections and ribavirin |
| 2 | Active comparator | 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. Receives: Drug: Interferon injections and ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of sustained virologic response (SVR) six months after completion of treatment.
Secondary outcomes (3)
Adherence to therapy
Cost
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2006 (estimated)
- Study startJun 2007
- Primary completionAug 2010
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus InfectionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Brian Conway, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399672
- Sponsor's protocol ID
- C06-0192
- Status last verified
- Nov 2016
- First submitted
- 14 Nov 2006
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Multi-disciplinary Approach for the Treatment of Hepatitis C in IDUs (HI-LO Study)
- ClinicalTrials.gov ID
- NCT00399672
- Acronym / sponsor ID
- C06-0192
- Conditions
- Hepatitis C Virus Infection
- Keywords
- HCV, injection drug users, ribavirin, pegylated interferon, illicit drug users
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jun 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Interferon injections and ribavirinThe 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. |
| 2 | Active comparator | Drug: Interferon injections and ribavirinThe 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 19 years;
- Serum HCV-RNA pos;
- HCV genotype 2 or 3;
- HBsAg neg;
- serum ALT > 1.5x upper limit normal > 3 months;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon injections and ribavirinWeekly pegylated interferon injections will be administered by clinic staff and ribavirin will be dispensed in weekly medication pack. | Drug | 1 |
| Interferon injections and ribavirinPatients 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. | Drug | 2 |
Primary outcome
Rate of sustained virologic response (SVR) six months after completion of treatment.
3 secondary outcomes
Adherence to therapy
Cost
Quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Conway, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interferon injections and ribavirin in people with Hepatitis C Virus Infection, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of sustained virologic response (SVR) six months after completion of treatment.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2016.