Simplified Monitoring Myanmar SM2 Study
SM2
Evaluation of Simplified HCV Diagnostics in HIV/HCV Co-infected Patients in Myanmar (Simplified Monitoring Myanmar SM2 Study)
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 22, 2019
CompletedFirst Submitted
Initial submission to the registry
October 1, 2019
CompletedFirst Posted
Study publicly available on registry
October 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2020
CompletedFebruary 21, 2021
February 1, 2021
1.9 years
October 1, 2019
February 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
12 weeks post completion of commenced treatment
Study Arms (1)
Sofosbuvir/Daclatasvir
OTHERstandard DAA therapy: 12 or 24 weeks of sofosbuvir/daclatasvir
Interventions
Xpert HCV Assay performed on the GeneXpert point of care machine
Eligibility Criteria
You may qualify if:
- Have voluntarily signed the consent form.
- years of age or older.
- HCV antibody positive.
- HIV antibody positive.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kirby Institutelead
- University of Public Health, Myanmarcollaborator
Study Sites (1)
The Kirby Institute, University of New South Wales Australia
Sydney, New South Wales, 2052, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2019
First Posted
October 3, 2019
Study Start
January 22, 2019
Primary Completion
December 22, 2020
Study Completion
December 22, 2020
Last Updated
February 21, 2021
Record last verified: 2021-02