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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Kirby Institute
Sponsor:
Information provided by (Responsible Party):
Kirby Institute
ClinicalTrials.gov Identifier:
NCT02102451
First received: March 20, 2014
Last updated: June 7, 2016
Last verified: June 2016
  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
Hepatitis C
HIV
HIV-HCV Coinfection

Study Type: Observational
Study Design: 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.

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


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


Estimated Enrollment: 1000
Study Start Date: July 2014
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Detailed Description:

This project has five major components which will occur independently but are linked to the central theme of controlling and eliminating HCV infection from the majority of 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):

HCV treatment scale‐up with PBS listed regimens will involve primary and tertiary clinics. All patients who are commencing HCV treatment will be invited to participate in CEASE‐T which will involve data collection regarding treatment with PBS listed regimens. The regimen and duration will be determined by the treating clinician according to PBS prescribing guidelines. At selected sites subjects will be offered enrollment into a more intensive follow‐up substudy (I‐STEP) involving collection of research EDTA plasma samples, patient completed behavioural questionnaires and FibroScan® (where available). Patients with recurrent viraemia during or following treatment (relapse/reinfection) may also be entered into a separate substudy cohort (CEASE‐V)

Recurrent Viraemia Treatment (CEASE-V) At selected sites patients with on‐treatment virological failure (nonresponse or viral breakthrough) or post‐treatment recurrent viraemia (relapse or reinfection) will be entered into an intensive follow‐up cohort (CEASE‐V). Participation will involve providing informed consent, collection of research EDTA plasma samples and patient completed behavioural questionnaires. Patients may be offered retreatment with PBS listed regimens. The decision to retreat as well as the regimen and duration will be determined by the treating clinician according to PBS prescribing guidelines

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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:

a) Non‐response: Failure of viral suppression on IFN‐free DAA therapy b) Virological breakthrough on IFN‐free DAA therapy c) Post‐treatment recurrent viraemia: Detectable HCV RNA post‐treatment following an end‐of‐treatment response (ETR, undetectable HCV RNA at end of treatment)

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

  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: Arlen Wilcox, BBsc +61 2 9385 9970 awilcox@kirby.unsw.edu.au
Contact: Pip Marks, BSc, MPH(Hons) +61 2 9385 0886 pmarks@kirby.unsw.edu.au

Locations
Australia, New South Wales
Dr Doong's Surgery Recruiting
Burwood, New South Wales, Australia, 2134
Principal Investigator: Nicholas Doong, MBBS, Dip Obst, MPH, FRACGP         
Blue Mountains Sexual Health and HIV Centre Recruiting
Katoomba, New South Wales, Australia, 2780
Principal Investigator: Eva Jackson, MBBS, FAChSHM         
Sydney Sexual Health Centre Recruiting
Sydney, New South Wales, Australia, 2000
Principal Investigator: Anna McNulty, MBBS, Dip Comm, M Med         
East Sydney Doctors Recruiting
Sydney, New South Wales, Australia, 2010
Principal Investigator: David Baker, MBChB, DCH, DipMed         
Holdsworth House Medical Practice Recruiting
Sydney, New South Wales, Australia, 2010
Principal Investigator: Mark Bloch, MBBS, DipFP, DipMedHyp, MMed         
Kirketon Road Centre Recruiting
Sydney, New South Wales, Australia, 2010
Principal Investigator: Phillip Read, MBBS, MRCP, FAChSHM, MPH         
St Vincent's Hospital Recruiting
Sydney, New South Wales, Australia, 2010
Principal Investigator: Greg Dore, BSc, MBBS, FRACP, MPH, PhD         
Taylor Square Private Clinic Recruiting
Sydney, New South Wales, Australia, 2010
Principal Investigator: Robert Finlayson, MBBS, FACSHP, FAChSH         
The Albion Centre Recruiting
Sydney, New South Wales, Australia, 2010
Principal Investigator: Rohan Bopage, MBBS, MMed, FAChSHM, FRACP         
Western Sydney Sexual Health Recruiting
Sydney, New South Wales, Australia, 2150
Principal Investigator: Rick Varma, MbChB, MRCP, FAChSHM         
Nepean Sexual Health and HIV Clinic Recruiting
Sydney, New South Wales, Australia, 2747
Principal Investigator: Rick Varma, MbChB, MRCP, FAChSHM         
Australia, Queensland
Brisbane Sexual Health Clinic Recruiting
Brisbane, Queensland, Australia, 4000
Principal Investigator: Diane Rowling, MBBS         
Cairns Sexual Health Service Not yet recruiting
Cairns North, Queensland, Australia, 4870
Principal Investigator: Darren Russel, MBBS         
Royal Brisbane Womens Hospital Not yet recruiting
Herston, Queensland, Australia, 4029
Principal Investigator: Krispin Hajkowicz, MBBS, MPH         
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia
Principal Investigator: David Shaw, MBBS         
Australia, Victoria
Melbourne Sexual Health Centre Not yet recruiting
Carlton, Victoria, Australia, 3053
Principal Investigator: Nicholas Medland, MBBS         
Northside Clinic Recruiting
Fitzroy North, Victoria, Australia, 3076
Principal Investigator: Richard Moore, MBBS         
The Alfred Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3004
Principal Investigator: Margaret Hellard, MBBS         
Royal Melbourne Hospital Not yet recruiting
Parkville, Victoria, Australia, 3050
Principal Investigator: Joe Sasadeusz, MBBS         
Prahran Market Clinic Not yet recruiting
Prahran, Victoria, Australia, 3181
Principal Investigator: Mark O'Reilly, MBBS         
The Centre Clinic Not yet recruiting
St Kilda, Victoria, Australia, 3182
Principal Investigator: Bam Kiem Tee, MBBS         
Sponsors and Collaborators
Kirby Institute
Investigators
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
  More Information

Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT02102451     History of Changes
Other Study ID Numbers: VHCRP1208 
Study First Received: March 20, 2014
Last Updated: June 7, 2016
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Individual Participant Data  
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:
Hepatitis
Hepatitis C
Coinfection
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Infection
Parasitic Diseases

ClinicalTrials.gov processed this record on December 09, 2016