GS 5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) in Chronic Genotype 1 Hepatitis C Virus (HCV) Infection
- Conditions
- Hepatitis C, Chronic
- Interventions
- Registration Number
- NCT01353248
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The purpose of this phase 2 study is to determine whether 30 mg or 90 mg of GS-5885 when given with GS-9451, Tegobuvir and Ribavirin (RBV) for 12 or 24 weeks is effective, safe and tolerable in the treatment of Chronic Genotype 1 HCV Infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 141
- Adult subjects 18 to 70 years of age
- Chronic HCV infection for at least 6 months prior to Baseline (Day 1)
- Liver biopsy results (performed no more than 2 years prior to Screening) indicating the absence of cirrhosis
- Monoinfection with HCV genotype 1a or 1b
- HCV treatment-naïve
- Body mass index (BMI) between 18 and 36 kg/m2
- Creatinine clearance ≥ 50 mL/min
- Subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.
- Screening laboratory values within defined thresholds
- Autoimmune disease
- Decompensated liver disease or cirrhosis
- Poorly controlled diabetes mellitus
- Severe psychiatric illness
- Severe chronic obstructive pulmonary disease (COPD)
- Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
- Suspicion of hepatocellular carcinoma or other malignancy (with exception of certain skin cancers)
- History of hemoglobinopathy
- Known retinal disease
- Subjects who are immunosuppressed
- Subjects with known, current use of amphetamines, cocaine, opiates (i.e., morphine, heroin), methadone, or ongoing alcohol abuse
- Subjects must have no history of clinically significant cardiac disease, including a family history of Long QT syndrome, and no relevant electrocardiogram (ECG) abnormalities at screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 ribavirin tablet GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 24 weeks. Arm 1 GS-5885 GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 24 weeks. Arm 2 Tegobuvir GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 12 or 24 weeks. Arm 2 GS-9451 GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 12 or 24 weeks. Arm 2 ribavirin tablet GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 12 or 24 weeks. Arm 2 GS-5885 GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 12 or 24 weeks. Arm 1 GS-9451 GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 24 weeks. Arm 1 Tegobuvir GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 24 weeks.
- Primary Outcome Measures
Name Time Method Sustained virologic response (SVR) 24 weeks of off-treatment follow-up
- Secondary Outcome Measures
Name Time Method HCV RNA < Lower Limit Of Quantification Weeks 1, 2, 4, 12 and 24 To evaluate the antiviral efficacy at Weeks 1, 2, 4, 12 and 24, as measured by the rates of HCV RNA \< LLoQ and viral breakthrough and relapse.
Emergence of viral resistance 12 or 24 weeks To evaluate the emergence of viral resistance during treatment with GS-9451, Tegobuvir and RBV when given with 30 mg or 90 mg GS-5885 for 12 or 24 weeks.
Pharmacokinetics of GS-5885, GS-9451 and Tegobuvir when administered in combination with RBV Through Week 2 of therapy Pharmacokinetics (Cmax, Tmax, Clast, Tlast, Ctau, λz, AUCtau, and T½) will be listed
and summarized for GS-5885, GS-9451 and Tegobuvir using descriptive statistics (e.g.,
sample size, arithmetic mean, geometric mean, % coefficient of variation, standard deviation,
median, minimum, and maximum). Plasma concentrations of the study drug over time will be
summarized using descriptive statisticsRescue Therapy Substudy SVR 24 Weeks To evaluate the antiviral efficacy (as defined by SVR) of the addition of pegylated interferon (PEG) for 24 weeks to GS-5885, GS-9451, tegobuvir and RBV in subjects who experience viral breakthrough on treatment.
Safety and tolerability through 24 weeks of off-treatment follow-up To evaluate the safety and tolerability of 30 mg or 90 mg GS-5885 when given with GS-9451, Tegobuvir and RBV for 12 or 24 weeks. Safety endpoints will be analyzed by the number and percent of subjects with events or abnormalities for categorical values or 8-number summary (n, mean, standard deviation, median, Q1, Q3, minimum, maximum) for continuous data by treatment group.
Viral dynamics of GS-5885, GS-9451 and Tegobuvir when administered in combination with RBV Through Week 2 of therapy HCV RNA levels, pharmacokinetics and viral sequencing
Trial Locations
- Locations (43)
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Digestive Health Specialists of the Southeast
🇺🇸Dothan, Alabama, United States
UCSF Fresno Medical Education Program (MEP)
🇺🇸Fresno, California, United States
Birmingham Gastroenterology Associates, P.C.
🇺🇸Birmingham, Alabama, United States
Stanford University School of Medicine
🇺🇸Palo Alto, California, United States
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
Fundacion de Investigacion de Diego
🇵🇷San Juan, Puerto Rico
Borland-Groover Clinic
🇺🇸Jacksonville, Florida, United States
Kaiser Permanente
🇺🇸San Diego, California, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Nashville Gastrointestinal Specialists, Inc
🇺🇸Nashville, Tennessee, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Lifetree Clinical Research, LC
🇺🇸Salt Lake City, Utah, United States
Columbia Medical Group, The Frist Clinic
🇺🇸Nashville, Tennessee, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
Southern California Liver Centers
🇺🇸Coronado, California, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
UCSF
🇺🇸San Francisco, California, United States
Bach and Godofsky Infectious Diseases
🇺🇸Bradenton, Florida, United States
University of Florida - Gainesville
🇺🇸Gainesville, Florida, United States
University of Miami School of Medicine
🇺🇸Miami, Florida, United States
Gastrointestinal Specialists of Georgia PC
🇺🇸Marietta, Georgia, United States
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Johns Hopkins University
🇺🇸Lutherville, Maryland, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Gastrointestinal Associates, PA
🇺🇸Jackson, Mississippi, United States
Options Health Research, LLC
🇺🇸Tulsa, Oklahoma, United States
University of Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
Memphis Gastroenterology Group
🇺🇸Germantown, Tennessee, United States
Research Specialists of Texas
🇺🇸Houston, Texas, United States
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
Inova Fairfax Hospital - Center for Liver Diseases
🇺🇸Falls Church, Virginia, United States
Liver Institute of Virginia, Bon Secours Health System
🇺🇸Newport News, Virginia, United States
Private Practice
🇺🇸Opelousas, Louisiana, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
University of California San Diego
🇺🇸San Diego, California, United States