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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02786758




Registration number
NCT02786758
Ethics application status
Date submitted
3/05/2016
Date registered
1/06/2016
Date last updated
28/02/2020

Titles & IDs
Public title
Eliminating Hepatitis C Transmission by Enhancing Care and Treatment Among HIV Co-infected Individuals
Scientific title
Eliminating Hepatitis C Transmission by Enhancing Care and Treatment Among HIV Co-infected Individuals: The Co-EC Study
Secondary ID [1] 0 0
burnet_coec_2016
Universal Trial Number (UTN)
Trial acronym
co-EC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
HIV 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
Treatment uptake
Timepoint [1] 0 0
18 months
Primary outcome [2] 0 0
Sustained virological response after treatment (SVR12)
Timepoint [2] 0 0
Change in sustained viral response rates post-treatment (SVR12).
Primary outcome [3] 0 0
HCV prevalence
Timepoint [3] 0 0
12 months
Primary outcome [4] 0 0
HCV incidence
Timepoint [4] 0 0
12 months
Secondary outcome [1] 0 0
Change in HCV testing among HIV-infected gay and bisexual men
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
Change in number of HIV/HCV infected gay and bisexual men who have a complete management plan including HCV RNA status, FibroScan and liver function tests.
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
Medical adherence
Timepoint [3] 0 0
Up to 24 weeks, documented at each study visit

Eligibility
Key inclusion criteria
1. Aged =18 years;
2. Attendance for medical care of HIV at any study site;
3. Evidence of chronic HCV infection (HCV antibody or RNA positive for =6 months and HCV RNA positive);
4. HIV infected;
5. Willing and able to provide written informed consent;

Subjects must meet routine clinical care criteria for commencing HCV treatment, in accordance with Australian licensing, prescribing restrictions, manufacturers' recommendations and best- practice clinical care.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy or breastfeeding at time of HCV antiviral treatment;
2. Evidence of any condition, therapy, laboratory abnormality or other circumstance (current or prior) that may confound the study's results, or interfere with participation for the full duration of the study, such that it is not in the best interest of the participant

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2019
Sample size
Target
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Melbourne Sexual Health Centre - Carlton
Recruitment hospital [2] 0 0
Alfred Health, The Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
Northside Clinic - North Fitzroy
Recruitment hospital [4] 0 0
Melbourne Health, Royal Melbourne Hospital - Parkville
Recruitment hospital [5] 0 0
Prahran Market Clinic - Prahran
Recruitment hospital [6] 0 0
Centre Clinic - St Kilda
Recruitment postcode(s) [1] 0 0
3053 - Carlton
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
3068 - North Fitzroy
Recruitment postcode(s) [4] 0 0
3052 - Parkville
Recruitment postcode(s) [5] 0 0
3181 - Prahran
Recruitment postcode(s) [6] 0 0
3182 - St Kilda

Funding & Sponsors
Primary sponsor type
Other
Name
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will offer proof of concept that scaling up treatment for Hepatitis C virus (HCV) in individuals co-infected with HIV could lead to elimination of HCV/HIV co-infection in gay and bisexual men by treating prevalent infection, thereby reducing new primary infections and re-infection.
Trial website
https://clinicaltrials.gov/study/NCT02786758
Trial related presentations / publications
Doyle JS, van Santen DK, Iser D, Sasadeusz J, O'Reilly M, Harney B, Traeger MW, Roney J, Cutts JC, Bowring AL, Winter R, Medland N, Fairley CK, Moore R, Tee BK, Asselin J, El-Hayek C, Hoy JF, Matthews GV, Prins M, Stoove MA, Hellard ME. Microelimination of Hepatitis C Among People With Human Immunodeficiency Virus Coinfection: Declining Incidence and Prevalence Accompanying a Multicenter Treatment Scale-up Trial. Clin Infect Dis. 2021 Oct 5;73(7):e2164-e2172. doi: 10.1093/cid/ciaa1500.
Public notes

Contacts
Principal investigator
Name 0 0
Margaret Hellard
Address 0 0
Burnet Institute
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/study/NCT02786758