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Direct-acting Antiviral Therapy and Reinfection Among People With Chronic Hepatitis C Virus Infection and Recent Injecting Drug Use in the Prison Setting (SHARP-P)

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ClinicalTrials.gov Identifier: NCT03740906
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Kirby Institute

Brief Summary:

SHARP-P 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 from correctional centres in New South Wales, Australia.

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.


Condition or disease
Hepatitis C, Chronic

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Direct-acting Antiviral Therapy and Reinfection Among People With Chronic Hepatitis C Virus Infection and Recent Injecting Drug Use in the Prison Setting (The SHARP-P Study)
Actual Study Start Date : September 6, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. To evaluate the incidence of HCV reinfection following successful DAA therapy among people with chronic HCV infection and recent injecting drug use in the prison setting. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. To evaluate the proportion of participants with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following DAA HCV therapy among PWID with chronic HCV infection and recent injecting drug use [ Time Frame: 2.5 years ]
  2. To evaluate the proportion of participants who complete treatment [ Time Frame: 3 years ]
  3. To evaluate the proportion of participants with undetectable HCV RNA at the end of treatment [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
EDTA Plasma, PBMCs, Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants with chronic HCV infection and recent injecting drug use who are 18 years or over and are eligible for DAA therapy as per the PBS criteria
Criteria

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. Report of recent injecting drug use (within the previous 6 months).
  5. Eligible for DAA therapy as per the PBS
  6. HIV-1 infected participants enrolled in the study must meet the following additional 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.

Exclusion Criteria:

1. The participant will be excluded from participating in the study if the subject is unable or unwilling to provide informed consent or abide by the requirements of the study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740906


Contacts
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Contact: Pip Marks +61 2 9385 0886 pmarks@kirby.unsw.edu.au
Contact: Andrew Lloyd a.lloyd@unsw.edu.au

Locations
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Australia, New South Wales
NSW Correctional Centres Recruiting
Sydney, New South Wales, Australia
Contact: Jodi Van Dyk       jvandyk@kirby.unsw.edu.au   
Sponsors and Collaborators
Kirby Institute
Investigators
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Principal Investigator: Andrew Lloyd Kirby Institute
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Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT03740906    
Other Study ID Numbers: VHCRP1606
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic