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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02102451




Registration number
NCT02102451
Ethics application status
Date submitted
20/03/2014
Date registered
3/04/2014
Date last updated
8/09/2021

Titles & IDs
Public title
Control and Elimination Within Australia of Hepatitis C From People Living With HIV
Scientific 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.
Secondary ID [1] 0 0
VHCRP1208
Universal Trial Number (UTN)
Trial acronym
CEASE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
HIV 0 0
HIV-HCV Coinfection 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HCV viraemia
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Needs, behaviour and attitudes towards HCV treatment
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
HCV treatment uptake
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Factors associated with HCV treatment and retreatment
Timepoint [3] 0 0
5 years
Secondary outcome [4] 0 0
HCV treatment response rates
Timepoint [4] 0 0
5 years
Secondary outcome [5] 0 0
Rates of HCV retreatment
Timepoint [5] 0 0
5 years
Secondary outcome [6] 0 0
HCV transmission history
Timepoint [6] 0 0
5 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2022
Actual
Sample size
Target
Accrual to date
Final
492
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Dr Doong's Surgery - Burwood
Recruitment hospital [2] 0 0
Blue Mountains Sexual Health and HIV Centre - Katoomba
Recruitment hospital [3] 0 0
Sydney Sexual Health Centre - Sydney
Recruitment hospital [4] 0 0
East Sydney Doctors - Sydney
Recruitment hospital [5] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [6] 0 0
Kirketon Road Centre - Sydney
Recruitment hospital [7] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [8] 0 0
Taylor Square Private Clinic - Sydney
Recruitment hospital [9] 0 0
The Albion Centre - Sydney
Recruitment hospital [10] 0 0
Western Sydney Sexual Health - Sydney
Recruitment hospital [11] 0 0
Nepean Sexual Health and HIV Clinic - Sydney
Recruitment hospital [12] 0 0
Brisbane Sexual Health Clinic - Brisbane
Recruitment hospital [13] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [14] 0 0
Melbourne Sexual Health Centre - Carlton
Recruitment hospital [15] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [16] 0 0
Northside Clinic - North Fitzroy
Recruitment hospital [17] 0 0
Prahran Market Clinic - Prahran
Recruitment hospital [18] 0 0
The Centre Clinic - St Kilda
Recruitment postcode(s) [1] 0 0
2134 - Burwood
Recruitment postcode(s) [2] 0 0
2780 - Katoomba
Recruitment postcode(s) [3] 0 0
2000 - Sydney
Recruitment postcode(s) [4] 0 0
2010 - Sydney
Recruitment postcode(s) [5] 0 0
2150 - Sydney
Recruitment postcode(s) [6] 0 0
2747 - Sydney
Recruitment postcode(s) [7] 0 0
4000 - Brisbane
Recruitment postcode(s) [8] 0 0
- Adelaide
Recruitment postcode(s) [9] 0 0
3053 - Carlton
Recruitment postcode(s) [10] 0 0
3004 - Melbourne
Recruitment postcode(s) [11] 0 0
3068 - North Fitzroy
Recruitment postcode(s) [12] 0 0
3181 - Prahran
Recruitment postcode(s) [13] 0 0
3182 - St Kilda

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT02102451
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gail Matthews, MbChB, MRCP, FRACP, PhD
Address 0 0
Kirby Institute, University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02102451