Simplified Monitoring Myanmar SM2 Study (SM2)
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|ClinicalTrials.gov Identifier: NCT04113629|
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : October 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Liver Cirrhoses Liver Inflammation HIV Infections||Device: HCV point of care machine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Simplified HCV Diagnostics in HIV/HCV Co-infected Patients in Myanmar (Simplified Monitoring Myanmar SM2 Study)|
|Actual Study Start Date :||January 22, 2019|
|Estimated Primary Completion Date :||December 22, 2020|
|Estimated Study Completion Date :||January 22, 2021|
standard DAA therapy: 12 or 24 weeks of sofosbuvir/daclatasvir
Device: HCV point of care machine
Xpert HCV Assay performed on the GeneXpert point of care machine
- Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) [ Time Frame: 12 weeks post completion of commenced treatment ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04113629
|Contact: PIp Marks, MPHfirstname.lastname@example.org|
|Australia, New South Wales|
|The Kirby Institute, University of New South Wales Australia||Recruiting|
|Sydney, New South Wales, Australia, 2052|
|Contact: Gail V Matthews, MbChB, PhD +61 2 9385 0900 email@example.com|
|Contact: Pip Marks +61 2 9385 0886 firstname.lastname@example.org|