Simplified Monitoring Myanmar SM2 Study

Not Applicable

Completed

• Conditions: Liver Inflammation; Hepatitis C; HIV Infections; Liver Cirrhoses
• Interventions: Device: HCV point of care machine

• Registration Number: NCT04113629
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-01-22
• Study First Submitted: 2019-10-01
• Study First Submitted QC: 2019-10-01
• Study First Posted: 2019-10-03
• Primary Completion: 2020-12-22
• Study Completion: 2020-12-22
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sofosbuvir/Daclatasvir	HCV point of care machine	standard DAA therapy: 12 or 24 weeks of sofosbuvir/daclatasvir

Primary Outcome Measures

Name	Time	Method
Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12)	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.

Trial Locations

Locations (1)

The Kirby Institute, University of New South Wales Australia; 🇦🇺 Sydney, New South Wales, Australia