|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02786758 |
|
Date of registration:
|
03/05/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Eliminating Hepatitis C Transmission by Enhancing Care and Treatment Among HIV Co-infected Individuals
co-EC |
|
Scientific title:
|
Eliminating Hepatitis C Transmission by Enhancing Care and Treatment Among HIV Co-infected Individuals: The Co-EC Study |
|
Date of first enrolment:
|
April 2016 |
|
Target sample size:
|
200 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02786758 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Australia
| | | | | | | |
|
Contacts
|
|
Name:
|
Margaret Hellard |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Burnet Institute |
|
|
Name:
|
Joseph Doyle |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
The Alfred |
| |
|
Key inclusion & exclusion criteria
|
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.
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
HIV
|
|
Hepatitis C
|
|
Primary Outcome(s)
|
|
HCV prevalence
[Time Frame: 12 months]
|
|
Sustained virological response after treatment (SVR12)
[Time Frame: Change in sustained viral response rates post-treatment (SVR12).]
|
|
HCV incidence
[Time Frame: 12 months]
|
|
Treatment uptake
[Time Frame: 18 months]
|
|
Secondary Outcome(s)
|
|
Change in HCV testing among HIV-infected gay and bisexual men
[Time Frame: 18 months]
|
|
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.
[Time Frame: 18 months]
|
|
Medical adherence
[Time Frame: Up to 24 weeks, documented at each study visit]
|
|
Secondary ID(s)
|
|
burnet_coec_2016
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|