Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT02102451
Eligibility Criteria:
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
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02102451
Study Brief:
Protocol Section:
NCT02102451