Study of A Combination Pill With GS-7977 and GS-5885 for Hepatitis C in People With HIV
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
Background:
- Present treatment for hepatitis C includes the use of a weekly injection and two different
pills. This treatment is associated with serious side effects. Drugs that can be taken by
mouth and cure HCV infection without serious side effects would be a great help to the large
number of people infected with HCV. GS-7977 and GS-5885 are new medications being developed
to treat the hepatitis C virus (HCV) infection. They are still being researched and are not
approved by the Food and Drug Administration. They are being developed as treatment for
hepatitis C as a single pill taken once a day.
Objectives:
- To determine whether a combination of the two study drugs can safely and effectively treat
HCV infection in people with HIV infection and who do not have cirrhosis of the liver.
Eligibility:
- Individuals who have HIV infection and have liver disease caused by infection with HCV.
Design:
- Participants will be screened with a physical exam and medical history. Blood samples
will be collected. Urine samples will be collected from participants who might become
pregnant. If a participant has not had a liver biopsy in the past 3 years, one will be
required.
- Participants will take one pill daily for 12 weeks. This pill will be a combination of
the two study drugs.
- Treatment will be monitored with frequent clinic visits and blood tests over a total of
60 weeks.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)