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NCT Number: NCT04113629

Simplified Monitoring Myanmar SM2 Study

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Genital Diseases HIV Infections Hepatitis Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Cirrhoses Liver Diseases Liver Inflammation RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Kirby Institute, University of New South Wales Australia

Sydney, New South Wales, 2052, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HCV point of care machine

Device

Xpert HCV Assay performed on the GeneXpert point of care machine

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kirby Institute

Other Gov

Collaborators

  • University of Public Health, Myanmar

Registry information

Official study title

Evaluation of Simplified HCV Diagnostics in HIV/HCV Co-infected Patients in Myanmar (Simplified Monitoring Myanmar SM2 Study)

Acronym: SM2

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 3, 2019
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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