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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT02073656
Eligibility Criteria:
Inclusion Criteria:
* HCV RNA ≥ 10,000 IU/mL at screening
* HCV genotype 1 or 4
* HIV-1 infection
* Cirrhosis determination, a fibroscan or liver biopsy may be required
* Screening laboratory values within defined thresholds
* Use of protocol specified method(s) of contraception if female of childbearing potential or sexually active male
Exclusion Criteria:
* Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol
* Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (HCC), or other malignancy (with the exception of certain resolved skin cancers)
* Hepatitis B virus (HBV) infection
* Pregnant or nursing female
* Chronic use of systemically administered immunosuppressive agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02073656
Study Brief:
Protocol Section:
NCT02073656