Clareo Health | Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
