Back to resultsSimplified Monitoring Myanmar SM2 Study (SM2)
Primary Purpose
Hepatitis C, Liver Cirrhoses, Liver Inflammation
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
HCV point of care machine
Sponsored by
About this trial
This is an interventional diagnostic trial for Hepatitis C
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Sites / Locations
- The Kirby Institute, University of New South Wales Australia
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Sofosbuvir/Daclatasvir
Arm Description
standard DAA therapy: 12 or 24 weeks of sofosbuvir/daclatasvir
Outcomes
Primary Outcome Measures
Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12)
To 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 virological monitoring.
Secondary Outcome Measures
Full Information
NCT ID
NCT04113629
First Posted
October 1, 2019
Last Updated
February 17, 2021
Sponsor
Kirby Institute
Collaborators
University of Public Health, Myanmar
1. Study Identification
Unique Protocol Identification Number
NCT04113629
Brief Title
Simplified Monitoring Myanmar SM2 Study
Acronym
SM2
Official Title
Evaluation of Simplified HCV Diagnostics in HIV/HCV Co-infected Patients in Myanmar (Simplified Monitoring Myanmar SM2 Study)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 22, 2019 (Actual)
Primary Completion Date
December 22, 2020 (Actual)
Study Completion Date
December 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kirby Institute
Collaborators
University of Public Health, Myanmar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 virological monitoring.
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 care medical procedures, each participant will complete a questionnaire and have blood taken for standard HCV RNA testing.
They will also have a finger-stick capillary blood sample collected for a HCV point of care test, using the the Xpert HCV Assay performed in the GeneXpert point of care machine.
Dried blood spot collection (DBS) for HCV core antigen and HCV RNA testing will be collected as a research sample. Concordance between standard of care method and new DBS method will be evaluated.
The proportion of patients reaching SVR will be calculated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Liver Cirrhoses, Liver Inflammation, HIV Infections
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sofosbuvir/Daclatasvir
Arm Type
Other
Arm Description
standard DAA therapy: 12 or 24 weeks of sofosbuvir/daclatasvir
Intervention Type
Device
Intervention Name(s)
HCV point of care machine
Intervention Description
Xpert HCV Assay performed on the GeneXpert point of care machine
Primary Outcome Measure Information:
Title
Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12)
Description
To 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 virological monitoring.
Time Frame
12 weeks post completion of commenced treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Facility Information:
Facility Name
The Kirby Institute, University of New South Wales Australia
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2052
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Simplified Monitoring Myanmar SM2 Study
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