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Simplified Monitoring Myanmar SM2 Study (SM2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04113629
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : October 9, 2019
Sponsor:
Collaborator:
University of Public Health, Yangon, Myanmar
Information provided by (Responsible Party):
Kirby Institute

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Liver Cirrhoses Liver Inflammation HIV Infections Device: HCV point of care machine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Sofosbuvir/Daclatasvir
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

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


Contacts
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Contact: PIp Marks, MPH +61293850886 pmarks@kirby.unsw.edu.au

Locations
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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    gmatthews@kirby.unsw.edu.au   
Contact: Pip Marks    +61 2 9385 0886    pmarks@kirby.unsw.edu.au   
Sponsors and Collaborators
Kirby Institute
University of Public Health, Yangon, Myanmar

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Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT04113629    
Other Study ID Numbers: VHCRP1803
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Cirrhosis
Inflammation
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Pathologic Processes
Sofosbuvir
Antiviral Agents
Anti-Infective Agents