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
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|
|Study Type :||Observational|
|Actual Enrollment :||492 participants|
|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|
- HCV viraemia [ Time Frame: 5 years ]Proportion of HCV viraemia within the Australian HIV-HCV population over a five year period
- 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
- HCV treatment uptake [ Time Frame: 5 years ]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 ]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 ]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 ]To monitor rates of retreatment including for treatment failure and for reinfection
- 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.
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
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
|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|