Combination Therapy for Chronic Hepatitis C Infection
Status:
Completed
Trial end date:
2015-08-01
Target enrollment:
Participant gender:
Summary
Background:
- GS-7977, GS-5885, GS-9669, and GS-9451 are new drugs for treating hepatitis C virus (HCV)
infection. GS-7977 may help treat the infection when used with other treatments like
interferon therapy. GS-5885, and GS-9669, and GS-9451 also lower the amount of HCV in the
body. Researchers want to see whether GS-7977 can be combined with any of the other three
drugs to treat HCV infection. Some participants will take GS-7977 and GS-5885. Others will
take GS-7977, GS-5885 and GS-9669 or GS-7977, GS-5885 and GS-9451.
Objectives:
- To see whether GS-7977 with GS-5885 alone or in combination with either GS-9669 or 9451 can
be used to treat HCV infection.
Eligibility:
Individuals at least 18 years of age who have chronic HCV infection and have never been
treated for it.
Individuals at least 18 years of age who have chronic HCV infection and have not responded to
interferon therapy.
Individuals at least 18 years of age who have chronic HCV infection with advanced liver
disease and have never been treated for HCV
Design:
Participants will be screened with a physical exam and medical history. Blood samples will be
collected. A liver biopsy may also be performed.
Some participants will take the two study drugs and some will take three study drugs. Those
who take GS-7977 and GS-5885 will have one daily tablet named fixed dose combination or FDC.
Those who take GS-7977 and CS-9669 will have three daily tablets taken once daily. Those who
take GS-7977 and GS-5885 and GS-9451 will take 2 pills once a day. GS-7977 and GS-5885 will
be combined in one pill and GS-9451 will be in another pill.
Treatment will be monitored with frequent blood tests. These tests will check liver function
and the level of HCV infection. Participants may have other blood tests as needed for
treatment.
Participants will have 4, 6 or 12 weeks of treatment depending on which study drugs are
scheduled to take. After they complete their schedule, they will stop treatment with the
study drugs. They may also have another liver biopsy.
Participants will have regular follow-up visits over the next 48 weeks. They will have
physical exams and provide blood samples....
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)