HCV Treatment in HIV Co-Infected Patients in Asia
NCT01838772 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 188
Last updated 2016-10-27
Summary
The purpose of this study is to assess the effectiveness and tolerability of hepatitis C virus (HCV) treatment in HIV co-infected patients in routine health care services in Asia through a pilot model of care for treatment of HCV in resource-limited settings.
Conditions
- Hepatitis C
- HIV
Interventions
- DRUG
-
Pegylated-Interferon and Ribavirin
This is an open-label, single arm demonstration study. Intervention consists in treatment with Pegylated-interferon (Peg-Intron®, 1.5 microgr/kg/week, as subcutaneous injection) and ribavirin (Rebetol®, weight-based dosing, 2-daily doses) for 48 weeks, or 24 weeks for patients with genotype 2 and 3, moderate liver fibrosis, and rapid virological response.
Sponsors & Collaborators
-
Kirby Institute
collaborator OTHER_GOV -
amfAR, The Foundation for AIDS Research
lead OTHER
Principal Investigators
-
Nicolas Durier, MD, MPH · TREAT Asia/ amfAR - The Foundation for AIDS Research
-
Gail Matthews, MD, PhD · Kirby Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-12-31
- Primary Completion
- 2016-06-30
- Completion
- 2016-09-30
Countries
- Indonesia
- Malaysia
- Thailand
- Vietnam
Study Locations
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