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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Kirby Institute
Sponsor:
Information provided by (Responsible Party):
Kirby Institute
ClinicalTrials.gov Identifier:
NCT02102451
First received: March 20, 2014
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Hepatitis C
HIV
HIV-HCV Coinfection
Drug: Sofosbuvir and ribavirin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 in Australia.

Resource links provided by NLM:


Further study details as provided by Kirby Institute:

Primary Outcome Measures:
  • HCV viraemia [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Proportion of HCV viraemia within the Australian HIV-HCV population over a five year period


Secondary Outcome Measures:
  • Needs, behaviour and attitudes towards HCV treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To assess the needs, risk behaviour and willingness to undergo treatment in HIV-HCV coinfected individuals

  • HCV treatment uptake [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To monitor levels and types of HCV treatment uptake over time as therapies for HCV infection evolve

  • Factors associated with HCV treatment and retreatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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

  • HCV treatment response rates [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To assess treatment response rates to the roll out of interferon-free DDA therapies including the reasons for treatment failure

  • Rates of HCV retreatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To monitor rates of retreatment including for treatment failure and for reinfection

  • HCV transmission history [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To characterise, using molecular epidemiology, HCV transmission history within the HIV-HCV coinfected population


Estimated Enrollment: 1000
Study Start Date: July 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hepatitis C treatment
Interferon-free direct acting antiviral treatment. Exact drug combination and regimen/s to be determined, based on phase II and III data released before the treatment phase commences.
Drug: Sofosbuvir and ribavirin
Exact drug combination and regimen/s to be determined, based on phase II and III data released before the treatment phase commences.

Detailed Description:

This project has four major components which will occur independently but are linked to the central theme of controlling and eradicating hepatitis C from the Australian HIV positive population.

Database of HIV-HCV individuals (CEASE-D):

Surveillance of HIV-HCV positive individuals will occur through the enrolment into the CEASE-D observational study database. The proportion with HCV viraemia in this population will be determined through three cross-sectional surveys; at enrolment (2014-2015), follow-up 1 (2016) and follow-up 2 (2018). Participation will involve providing informed consent, collection of limited clinic and demographic information, a dried blood spot sample, patient completed CEASE questionnaires and FibroScan® (where available). It is estimated that approximately 1000 HIV-HCV coinfected individuals will be enrolled into the CEASE-D database.

Modelling (CEASE-M):

Mathematical modeling will be undertaken to examine various treatment strategies, including HCV treatment scale-up timelines. The data from the first cross-sectional survey of the HCV surveillance phase (CEASE-D) will inform components of the modeling.

HCV Education for HIV prescribers (CEASE-E):

A comprehensive education program in HCV treatment with interferon-free DAA therapy will be conducted with HIV prescribers with high HCV caseloads in preparation for the rapid scale-up of HCV treatment.

HCV Treatment Scale-Up (CEASE-T):

An initial pilot phase will involve clinics (tertiary care and primary care) with existing HCV treatment programs, with early access to interferon-free DAA regimens pre-PBS listing through pharma-sponsored early access schemes or clinical trials protocols. This will be followed by an expanded phase following PBS listing.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

CEASE-D:

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

CEASE-T:

  • 18 years of age or older
  • Voluntarily signed the informed consent form
  • HIV positive
  • HCV antibody positive
  • The exact treatment regimen will be determined prior to the commencement of the treatment intervention phase, and inclusion criteria relevant to the regimen defined in line with this decision.

Exclusion Criteria:

CEASE-D:

  • Inability or unwillingness to comply with protocol requirements

CEASE-T:

  • Exclusion criteria specific to the drug regimen/s will be submitted once the regimen/s has been selected.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02102451

Contacts
Contact: Jasmine Skurowski, BSc +61 2 9385 0932 jskurowski@kirby.unsw.edu.au
Contact: Pip Marks, BSc, MPH(Hons) +61 2 9385 0886 pmarks@kirby.unsw.edu.au

Locations
Australia, New South Wales
St Vincent's Hospital Not yet recruiting
Sydney, New South Wales, Australia, 2010
Principal Investigator: Greg Dore, BSc, MBBS, FRACP, MPH, PhD         
Taylor Square Private Clinic Not yet recruiting
Sydney, New South Wales, Australia, 2010
Principal Investigator: Robert Finlayson, MBBS,FACSHP,FAChSH         
East Sydney Doctors Not yet recruiting
Sydney, New South Wales, Australia, 2010
Principal Investigator: David Baker, MBChB,DCH,DipMed         
Holdsworth House Medical Practice Not yet recruiting
Sydney, New South Wales, Australia, 2010
Principal Investigator: Mark Bloch, MBBS,DipFP,DipMedHyp,MMed         
Sponsors and Collaborators
Kirby Institute
Investigators
Principal Investigator: Gail Matthews, MbChB, MRCP, FRACP, PhD Kirby Institute, University of New South Wales; St Vincent's Hospital Sydney
Principal Investigator: Greg Dore, BSc, MBBS, FRACP, MPH, PhD Kirby Institute, University of New South Wales; St Vincent's Hospital Sydney
  More Information

No publications provided

Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT02102451     History of Changes
Other Study ID Numbers: VHCRP1208
Study First Received: March 20, 2014
Last Updated: July 21, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Kirby Institute:
Interferon-free
Direct acting antiviral (DAA)
Treatment as prevention
Surveillance
Feasibility

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Coinfection
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Infection
Parasitic Diseases

ClinicalTrials.gov processed this record on September 16, 2014