NCT02102451

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
492

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Longer than P75 for all trials

Geographic Reach
1 country

18 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

8.4 years

First QC Date

March 20, 2014

Last Update Submit

September 6, 2021

Conditions

Hepatitis CHIVHIV-HCV Coinfection

Keywords

Interferon-freeDirect acting antiviral (DAA)Treatment as preventionSurveillanceFeasibility

Outcome Measures

Primary Outcomes (1)

  • HCV viraemia

    Proportion of HCV viraemia within the Australian HIV-HCV population over a five year period

    5 years

Secondary Outcomes (6)

  • Needs, behaviour and attitudes towards HCV treatment

    5 years

  • HCV treatment uptake

    5 years

  • Factors associated with HCV treatment and retreatment

    5 years

  • HCV treatment response rates

    5 years

  • Rates of HCV retreatment

    5 years

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults living with HIV-HCV coinfection

You may qualify if:

  • CEASE-D:
  • 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 (ISTEP):
  • years of age or older
  • Voluntarily signed the informed consent form
  • HIV positive
  • HCV RNA positive
  • Adequate English and mental health status to provide written informed consent and comply with study procedures
  • Undergoing DAA therapy HCV treatment.
  • CEASE-V:
  • years of age or older
  • +13 more criteria

You may not qualify if:

  • CEASE-D:
  • \) Inability or willingness to comply with protocol requirements
  • CEASE-T:
  • \) Inability or willingness to comply with protocol requirements
  • CEASE-V:
  • \) Inability or willingness to comply with protocol requirements
  • DBS Sub-study:
  • \) Inability or willingness to comply with protocol requirements
  • CEASE-Q:
  • \) Inability or willingness to comply with protocol requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Dr Doong's Surgery

Burwood, New South Wales, 2134, Australia

Location

Blue Mountains Sexual Health and HIV Centre

Katoomba, New South Wales, 2780, Australia

Location

Sydney Sexual Health Centre

Sydney, New South Wales, 2000, Australia

Location

East Sydney Doctors

Sydney, New South Wales, 2010, Australia

Location

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Location

Kirketon Road Centre

Sydney, New South Wales, 2010, Australia

Location

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Taylor Square Private Clinic

Sydney, New South Wales, 2010, Australia

Location

The Albion Centre

Sydney, New South Wales, 2010, Australia

Location

Western Sydney Sexual Health

Sydney, New South Wales, 2150, Australia

Location

Nepean Sexual Health and HIV Clinic

Sydney, New South Wales, 2747, Australia

Location

Brisbane Sexual Health Clinic

Brisbane, Queensland, 4000, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Location

Melbourne Sexual Health Centre

Carlton, Victoria, 3053, Australia

Location

Northside Clinic

Fitzroy North, Victoria, 3068, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Prahran Market Clinic

Prahran, Victoria, 3181, Australia

Location

The Centre Clinic

St Kilda, Victoria, 3182, Australia

Location

Related Publications (2)

  • Martinello M, Carson JM, Post JJ, Finlayson R, Baker D, Read P, Shaw D, Bloch M, Doyle J, Hellard M, Filep E, Hosseini-Hooshyar S, Dore GJ, Matthews GV. Control and Elimination of Hepatitis C Virus Among People With HIV in Australia: Extended Follow-up of the CEASE Cohort (2014-2023). Open Forum Infect Dis. 2024 Dec 17;11(12):ofae665. doi: 10.1093/ofid/ofae665. eCollection 2024 Dec.

    PMID: 39691290DERIVED

  • Martinello M, Yee J, Bartlett SR, Read P, Baker D, Post JJ, Finlayson R, Bloch M, Doyle J, Shaw D, Hellard M, Petoumenos K, Lin L, Marks P, Applegate T, Dore GJ, Matthews GV. Moving Towards Hepatitis C Microelimination Among People Living With Human Immunodeficiency Virus in Australia: The CEASE Study. Clin Infect Dis. 2020 Sep 12;71(6):1502-1510. doi: 10.1093/cid/ciz985.

    PMID: 31585005DERIVED

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

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2014

First Posted

April 3, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

September 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

AU(18)