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Control and Elimination Within Australia of Hepatitis C From People Living With HIV (CEASE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02102451
Recruitment Status : Active, not recruiting
First Posted : April 3, 2014
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Kirby Institute

Brief Summary:

The purpose of this study is to evaluate the feasibility of rapid scale-up of new hepatitis C (HCV) treatments, known as interferon-free Direct Acting Antiviral (DAA) drugs, and impact on the proportion of people with HCV within the HIV-HCV coinfected population of Australia.

It is hypothesised that a rapid scale-up of hepatitis C treatment with interferon-free therapies in individuals with HIV-HCV coinfection will assist in controlling HCV infection in this population.


Condition or disease
Hepatitis C HIV HIV-HCV Coinfection

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Study Type : Observational
Actual Enrollment : 492 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: A Five Year Plan of Enhanced HCV Monitoring, Primary Care-Based Workforce Development, Rapid Scale-up of HCV Treatment and Public Health Policy Action in HIV Positive Individuals Within Australia.
Actual Study Start Date : July 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. HCV viraemia [ Time Frame: 5 years ]
    Proportion of HCV viraemia within the Australian HIV-HCV population over a five year period


Secondary Outcome Measures :
  1. Needs, behaviour and attitudes towards HCV treatment [ Time Frame: 5 years ]
    To assess the needs, risk behaviour and willingness to undergo treatment in HIV-HCV coinfected individuals

  2. HCV treatment uptake [ Time Frame: 5 years ]
    To monitor levels and types of HCV treatment uptake over time as therapies for HCV infection evolve

  3. Factors associated with HCV treatment and retreatment [ Time Frame: 5 years ]
    To examine factors which are associated with treatment and retreatment uptake at the tertiary, secondary and primary care level, including the influence of liver stage disease, genotype and availability of treatment regimens on treatment decision making

  4. HCV treatment response rates [ Time Frame: 5 years ]
    To assess treatment response rates to the roll out of interferon-free DDA therapies including the reasons for treatment failure

  5. Rates of HCV retreatment [ Time Frame: 5 years ]
    To monitor rates of retreatment including for treatment failure and for reinfection

  6. HCV transmission history [ Time Frame: 5 years ]
    To characterise, using molecular epidemiology, HCV transmission history within the HIV-HCV coinfected population


Biospecimen Retention:   Samples With DNA

Dry Blood Spot -whole blood collected on filter paper and dried.

EDTA Plasma

Peripheral Blood Mononuclear Cell's (PBMC's)

Samples will be used for HCV related tests including HCV antibody, HCV RNA and HCV genotypes/sequencing that will be performed at the central laboratory from the research samples



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:   No
Sampling Method:   Probability Sample
Study Population
Adults living with HIV-HCV coinfection
Criteria

Inclusion Criteria:

CEASE-D:

  1. 18 years of age or older
  2. Voluntarily signed the informed consent form
  3. HIV positive
  4. HCV antibody positive
  5. Adequate English and mental health status to provide written informed consent and comply with study procedures

CEASE-T (ISTEP):

  1. 18 years of age or older
  2. Voluntarily signed the informed consent form
  3. HIV positive
  4. HCV RNA positive
  5. Adequate English and mental health status to provide written informed consent and comply with study procedures
  6. Undergoing DAA therapy HCV treatment.

CEASE-V:

  1. 18 years of age or older
  2. Voluntarily signed the informed consent form
  3. HIV positive
  4. Undergone IFN-free DAA therapy for HCV

6) On treatment virological failure or post-treatment recurrent viraemia as defined by either:

  1. Non-response: Failure of viral suppression on IFN-free DAA therapy
  2. Virological breakthrough on IFN-free DAA therapy
  3. Post-treatment recurrent viraemia: Detectable HCV RNA post-treatment following an end-of-treatment response (ETR, undetectable HCV RNA at end of treatment)

    DBS Sub-study Population:

    1) 18 years of age or older 2) Voluntarily signed the informed consent form 3) HIV positive 4) HCV antibody positive 5) Adequate English and mental health status to provide written informed consent and comply with study procedures 6) Under follow-up within I-STEP post-treatment for HCV

    DBS Sub-study Controls:

    1) 18 years of age or older 2) Voluntarily signed the informed consent form 3) HIV negative 4) HCV antibody positive 5) Undergoing DAA therapy for HCV and requiring confirmation of SVR post therapy 6) Adequate English and mental health status to provide written informed consent and comply with study procedures

    CEASE-Q:

    1) 18 years of age or older 2) Voluntarily signed the informed consent form 3) HIV positive 4) HCV antibody positive 5) Adequate English and mental health status to provide written informed consent and comply with study procedures 6) Under follow-up within I-STEP post-treatment for HCV

    Exclusion Criteria:

    CEASE-D:

    1) Inability or willingness to comply with protocol requirements

    CEASE-T:

    1) Inability or willingness to comply with protocol requirements

    CEASE-V:

    1) Inability or willingness to comply with protocol requirements

    DBS Sub-study:

    1) Inability or willingness to comply with protocol requirements

    CEASE-Q:

    1) Inability or willingness to comply with protocol requirements


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): NCT02102451


Locations
Show Show 18 study locations
Sponsors and Collaborators
Kirby Institute
Investigators
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Principal Investigator: Gail Matthews, MbChB, MRCP, FRACP, PhD Kirby Institute, University of New South Wales
Principal Investigator: Greg Dore, BSc, MBBS, FRACP, MPH, PhD Kirby Institute, University of New South Wales
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT02102451    
Other Study ID Numbers: VHCRP1208
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kirby Institute:
Interferon-free
Direct acting antiviral (DAA)
Treatment as prevention
Surveillance
Feasibility
Additional relevant MeSH terms:
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Coinfection
Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Infection
Parasitic Diseases