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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03343925




Registration number
NCT03343925
Ethics application status
Date submitted
8/11/2017
Date registered
17/11/2017
Date last updated
21/11/2019

Titles & IDs
Public title
Direct-acting Antiviral Therapy and Reinfection Among PWID With Chronic HCV in Community-based Settings
Scientific title
Direct-acting Antiviral Therapy and Reinfection Among People With Chronic Hepatitis C Virus Infection and Recent Injecting Drug Use in Community-based Settings: the SHARP-C Study
Secondary ID [1] 0 0
VHCRP1605
Universal Trial Number (UTN)
Trial acronym
SHARP-C
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reinfection - Incidence of HCV reinfection following successful DAA therapy.
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Undetectable HCV RNA at SVR12 - The proportion of participants with a treatment response at SVR12
Timepoint [1] 0 0
2.5 years
Secondary outcome [2] 0 0
Treatment completion - The proportion of participants who complete treatment
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Undetectable HCV RNA at the end of treatment - The proportion of participants with undetectable HCV RNA at the end of treatment
Timepoint [3] 0 0
3 years

Eligibility
Key inclusion criteria
1. Participants have voluntarily signed the informed consent form.

2. Be =18 years of age on day of signing informed consent form.

3. Have chronic HCV infection.

4. Recent injecting drug use (previous 6 months).

5. Eligible for DAA therapy as per the Pharmaceutical Benefits Scheme (PBS) criteria

6. HIV-1 infected participants enrolled in the study must meet the following criteria:

1. 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.

2. 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
Drug and Alcohol Services (Hunter) - Newcastle
Recruitment hospital [4] 0 0
Infectious Diseases Clinic, Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2751 - Kingswood
Recruitment postcode(s) [3] 0 0
2300 - Newcastle
Recruitment postcode(s) [4] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

Summary
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. A prospective, observational cohort design will be used to enrol patients
attending tertiary drug and alcohol and primary health care services.

Participants will be prescribed a direct-acting HCV medication as per the standard of care.
The on treatment phase will vary dependent on the type of a direct-acting antiviral
prescribed as per the standard of care. Once patients have completed their treatment course
they will be followed up every 3 months for up to 3 years following the end of treatment
phase.

The study will aim to evaluate the incidence of HCV reinfection following successful DAA
treatment over the three years of follow up. The study will also evaluate the proportion of
patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) with
direct-acting anti-viral HCV therapy.
Trial website
https://clinicaltrials.gov/show/NCT03343925
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jason Grebely
Address 0 0
Kirby Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pip Marks
Address 0 0
Country 0 0
Phone 0 0
+61 2 9385 0886
Fax 0 0
Email 0 0
pmarks@kirby.unsw.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03343925