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 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT02220868
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* Chronic HCV genotype 1 infection
* Receiving emtricitabine/tenofovir/cobicistat/elvitegravir for at least 8 weeks.
* CD4 count \>200 cells/mm3 at screening and no CD4 count \<200 in previous 12 weeks
* HIV RNA PCR \<50 copies/ml at screening and no HIV RNA PCR \> 200 copies/ml in previous 12 weeks
Exclusion Criteria:
* History of integrase inhibitor resistance
* History of integrase inhibitor failure
* Absolute neutrophil counts under 1500/mm3 ( Black/ African Americans \<1200/mm3
* Patients with cirrhosis
* Platelet count under 90,000 per cubic millimeter
* Hemoglobin levels \<11 gm/dl in women or \<12 gm/dl in men
* Previous treatment with a DAA
* Hepatocellular carcinoma
* AFP\>100 ng/mL
* hepatitis B virus (HBsAg positive)
* Evidence of decompensated liver disease including, but not limited to, a history of presence of clinical ascites, bleeding varices, or hepatic encephalopathy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02220868
Study Brief:
Protocol Section:
NCT02220868