Status:
COMPLETED
Generic VEL/SOF With or Without RBV for HIV/HCV Coinfected Patients
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Hepatitis C Virus Infection, Response to Therapy of
Human Immunodeficiency Virus
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
Data are limited regarding the effectiveness and safety of generic velpatasvir plus sofosbuvir (VEL/SOF) with or without ribavirin (RBV) for the treatment of hepatitis C virus (HCV) in patients with h...
Detailed Description
Due to the lack of effective vaccination and the shared routes of transmission, hepatitis C virus (HCV) infection remains a challenging co-morbidity in patients with human immunodeficiency virus (HIV)...
Eligibility Criteria
Inclusion
- Age \> or = 20 years
- Chronic HCV infection, defined as detectable HCV antibody (anti-HCV; Abbott HCV EIA 2.0, Abbott Laboratories, Abbott Park, Illinois, USA) and quantifiable serum HCV RNA (Cobas TaqMan HCV Test v2.0, Roche Diagnostics GmbH, Mannheim, Germany, lower limit of quantification \[LLOQ\]: 25 IU/mL) for ≥ 6 months
Exclusion
- Chronic kidney disease (CKD) stage ≥ 4,
- Organ transplantation
- Prior DAA exposure
- Refusal to provide written informed consent.
Key Trial Info
Start Date :
August 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2017
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT03250910
Start Date
August 1 2016
End Date
October 31 2017
Last Update
December 8 2017
Active Locations (2)
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1
National Taiwan University Hospital, Yun-Lin Branch
Douliu, Taiwan
2
National Taiwan University Hospital
Taipei, Taiwan