Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV
Status:
Terminated
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
Background:
- Standard treatment for the hepatitis C virus (HCV) is a combination of the drugs peg-IFN
and ribavirin. However, this treatment is not very effective in people with a serious type of
HCV (HCV genotype 1) and also in people who have human immunodeficiency virus (HIV)
coinfection. Researchers want to add a new drug, boceprevir to see if it can improve
treatment results in people with both HCV genotype 1 and HIV. Boceprevir used in combination
with peg-IFN and ribavirin has been recently approved for the treatment of people with HCV
genotype 1 infection only, and is currently being studied in those with HIV and HCV.
Objectives:
- To test boceprevir, peg-IFN, and ribavirin as a treatment for HCV genotype 1 in people with
HCV monoinfection compared to those with both HIV and HCV infections.
Eligibility:
- Individuals at least 18 years of age who have HCV genotype 1 infection, and have not
received interferon treatment for HCV
- Half of the study participants will also have HIV infection.
Design:
- Participants will be screened with a medical history and physical exam. They will also
have blood and urine tests.
- Participants will also have heart and liver function tests, and answer questions about
mood and depression.
- Those in the study will receive ribavirin tablets to take twice a day, and peg-IFN to
inject under the skin weekly.
- Two weeks after starting treatment, participants will have blood tests to study the
treatment.
- Four weeks after starting treatment, participants will start taking boceprevir three
times a day.
- Participants will have regular study visits with blood samples and other tests. The
length of therapy will depend on the level of virus detected in the blood at several
clinic visits. Those who do not respond well to the medicines at 12 weeks will stop
treatment. The full length of treatment is 48 weeks.
Phase:
Phase 4
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)