Status:
COMPLETED
Direct-acting Antiviral Therapy and Reinfection Among PWID With Chronic HCV in Community-based Settings
Lead Sponsor:
Kirby Institute
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Brief Summary
SHARP-C is an observational cohort study investigating the effect of direct-acting antiviral (DAA) therapy and reinfection in people with chronic hepatitis C virus (HCV) and recent injecting drug use....
Detailed Description
In Australia, hepatitis C virus (HCV)-related morbidity and mortality have doubled in the past decade, with health care costs of $220 million per annum1. This is due to a large, ageing population with...
Eligibility Criteria
Inclusion
- Participants have voluntarily signed the informed consent form.
- Be ≥18 years of age on day of signing informed consent form.
- Have chronic HCV infection.
- Recent injecting drug use (previous 6 months).
- Eligible for DAA therapy as per the Pharmaceutical Benefits Scheme (PBS) criteria
- HIV-1 infected participants enrolled in the study must meet the following criteria:
- Have HIV infection documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry (Baseline) and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen, or plasma HIV-1 RNA viral load.
- Be on HIV Antiretroviral Therapy (ART) for at least 4 weeks prior to study entry using an ART regimen that is allowable with the intended DAA regimen as determined by the current PI and the Liverpool drug interaction website (http://www.hiv-druginteractions.org/) OR be naive to treatment with any antiretroviral therapy (ART) with a baseline CD4 count of \>200 and have no plans to initiate ART treatment while participating in this study and through to at least Follow-up Week 4.
Exclusion
- 1\) The participant must be excluded from participating in the trial if the subject is unable or unwilling to provide informed consent or abide by the requirements of the study.
Key Trial Info
Start Date :
August 17 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 11 2022
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03343925
Start Date
August 17 2018
End Date
April 11 2022
Last Update
April 14 2022
Active Locations (4)
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1
St Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
2
Nepean Hospital
Kingswood, New South Wales, Australia, 2751
3
Drug and Alcohol Services (Hunter)
Newcastle, New South Wales, Australia, 2300
4
Infectious Diseases Clinic, Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000