Simplified Monitoring Myanmar SM2 Study

NCT ID: NCT04113629

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-22
• Study Completion Date: 2020-12-22

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.

Conditions

Hepatitis C; Liver Cirrhoses; Liver Inflammation; HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sofosbuvir/Daclatasvir

standard DAA therapy: 12 or 24 weeks of sofosbuvir/daclatasvir

Group Type: OTHER

HCV point of care machine

Intervention Type: DEVICE

Xpert HCV Assay performed on the GeneXpert point of care machine

Interventions

HCV point of care machine

Xpert HCV Assay performed on the GeneXpert point of care machine

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Have voluntarily signed the consent form.

2. 18 years of age or older.

3. HCV antibody positive.

4. HIV antibody positive.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Public Health, Myanmar

OTHER

Sponsor Role: collaborator

Kirby Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Kirby Institute, University of New South Wales Australia

Sydney, New South Wales, Australia

Countries

Australia

Other Identifiers

VHCRP1803

Identifier Type: -

Identifier Source: org_study_id