Status:
COMPLETED
Simplified Monitoring Myanmar SM2 Study
Lead Sponsor:
Kirby Institute
Collaborating Sponsors:
University of Public Health, Myanmar
Conditions:
Hepatitis C
Liver Cirrhoses
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study will evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) following a course of DAA therapy delivered using a simplified schedule of safety and vi...
Detailed Description
A total of 200 HIV/HCV co-infected patients who plan to commence DAA therapy at Specialist Hospital Waibargi and Mingaladon, will be enrolled by simple random sampling. In addition to standard of car...
Eligibility Criteria
Inclusion
- Subjects must meet all of the following inclusion criteria to participate in this study.
- Have voluntarily signed the consent form.
- 18 years of age or older.
- HCV antibody positive.
- HIV antibody positive.
Exclusion
- Subjects who meet any of the exclusion criteria are not to be enrolled in this study.
- Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the subject treatment, assessment or compliance with the protocol.
- Creatinine clearance (CLcr) \< 30mL/min at screening.
- Pregnant or nursing female.
- Use of prohibited concomitant medications.
- Inability or unwillingness to provide informed consent or abide by the study requirements.
Key Trial Info
Start Date :
January 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04113629
Start Date
January 22 2019
End Date
December 22 2020
Last Update
February 21 2021
Active Locations (1)
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1
The Kirby Institute, University of New South Wales Australia
Sydney, New South Wales, Australia, 2052