Simplified Monitoring Myanmar SM2 Study (SM2)

February 17, 2021 updated by: Kirby Institute

Evaluation of Simplified HCV Diagnostics in HIV/HCV Co-infected Patients in Myanmar (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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2052
        • The Kirby Institute, University of New South Wales Australia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks post completion of commenced treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirby Institute

Collaborators

University of Public Health, Myanmar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 22, 2019

Primary Completion (ACTUAL)

December 22, 2020

Study Completion (ACTUAL)

December 22, 2020

Study Registration Dates

First Submitted

October 1, 2019

First Submitted That Met QC Criteria

October 1, 2019

First Posted (ACTUAL)

October 3, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VHCRP1803

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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