Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-02-25 @ 5:33 PM
Study NCT ID:
NCT02609893
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2015-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Treatment as Prevention for HCV Among Persons Who Actively Inject Drugs
Sponsor:
Phillip Coffin, MD, MIA
Organization:
Study Overview
Official Title:
Pilot Treatment as Prevention for HCV Among Persons Who Actively Inject Drugs
Status:
COMPLETED
Status Verified Date:
2020-10
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:
BYE-C
Brief Summary:
This project is a randomized trial of two strategies to treat persons with genotype 1 HCV who currently inject drugs (PWIDs) with a once daily regime of ledipasvir-sofosbuvir (LDV-SOF) for 8 weeks. The study will enroll 30 participants and will assess the feasibility and acceptability of treating active PWIDs for HCV with LDV-SOF by modified directly observed therapy (mDOT) versus unobserved dosing, with motivational interviewing based adherence support; and assess through in-depth, semi-structured qualitative interviews, the challenges with time intensity required for mDOT and unobserved dosing interventions, and identify key factors affecting treatment adherence.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: