Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399672
Status:
COMPLETED
Last Update Posted:
2016-11-30
First Post:
2006-11-14
Brief Title:
Evaluation of a Multi-disciplinary Approach for the Treatment of Hepatitis C in IDUs HI-LO Study
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Evaluation of a Multi-disciplinary Approach for the Treatment of Hepatitis C in IDUs HI-LO Study
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although injection drug users IDUs account for over 70 of new cases of HCV infectionyear 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 2000 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 100study 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 patientssite 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 patientssite 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None