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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04113629




Registration number
NCT04113629
Ethics application status
Date submitted
1/10/2019
Date registered
3/10/2019
Date last updated
21/02/2021

Titles & IDs
Public title
Simplified Monitoring Myanmar SM2 Study
Scientific title
Evaluation of Simplified HCV Diagnostics in HIV/HCV Co-infected Patients in Myanmar (Simplified Monitoring Myanmar SM2 Study)
Secondary ID [1] 0 0
VHCRP1803
Universal Trial Number (UTN)
Trial acronym
SM2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Liver Cirrhoses 0 0
Liver Inflammation 0 0
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - HCV point of care machine

Other: Sofosbuvir/Daclatasvir - standard DAA therapy: 12 or 24 weeks of sofosbuvir/daclatasvir


Treatment: Devices: HCV point of care machine
Xpert HCV Assay performed on the GeneXpert point of care machine
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12)
Timepoint [1] 0 0
12 weeks post completion of commenced treatment

Eligibility
Key inclusion criteria
Subjects must meet all of the following inclusion criteria to participate in this study.

1. Have voluntarily signed the consent form.

2. 18 years of age or older.

3. HCV antibody positive.

4. HIV antibody positive.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects who meet any of the exclusion criteria are not to be enrolled in this study.

1. 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.

2. Creatinine clearance (CLcr) < 30mL/min at screening.

3. Pregnant or nursing female.

4. Use of prohibited concomitant medications.

5. Inability or unwillingness to provide informed consent or abide by the study
requirements.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/12/2020
Sample size
Target
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The Kirby Institute, University of New South Wales Australia - Sydney
Recruitment postcode(s) [1] 0 0
2052 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Public Health, Myanmar
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT04113629
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04113629